- 1 -

Act No.11690, Mar.23, 2013, Other Laws and Regulations Amended

1. Pharmaceutical Affairs Act (Act)

- 2 -

CHAPTER I GENERAL PROVISIONS

Article 1 (Purpose)

The purpose of this Act is to prescribe the matters that are needed to have the matters regarding pharmaceutical affairs achieved smoothly, thereby to contribute to the improvement of national public health.

Article 2 (Definitions)

The definitions of terms used in this Act shall be as follows: <Amended by Act No. 8643, Oct.

17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9847, Dec. 29, 2009; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

1. The term "pharmaceutical affairs" means the manufacture, preparation, evaluation, safekeeping, importation and sale (including presentation; hereinafter the same shall apply) of medicinal products and quasi-drugs, and other matters related to pharmaceutical technology;

2. The term "pharmacist" means a person who takes charge of the matters concerning pharmaceutical affairs (including those concerning herbal medicinal product), other than those concerning herb drugs, and the term "oriental pharmacist" means a person who takes charge of the matters concerning pharmaceutical affairs related to herb drugs and preparation thereof, and both of them shall be licensed by the Minister of Health and Welfare;

3. The term "pharmacy" means a place where a pharmacist or oriental pharmacist prepares drugs (including the preparation of pharmacy medication) for the purpose of presentation (including the place needed for distribution business in cases where the founder of the pharmacy engages in drug distribution business at the same time): Provided, That dispensaries of medical institutions shall be excluded;

4. The term "medicinal product" means an article falling under any of the following items:(a) Those, other than quasi-drugs, among the articles listed in the Pharmacopoeia of the

Republic of Korea;(b) Articles used for the purpose of diagnosis, medical care, alleviation, treatment or

prevention of diseases of human beings or animals, excluding appliances, machinery or equipment;

(c) Articles, other than appliances, machinery or equipment, used for the purpose of exerting pharmacological effect upon the structure or functions of human beings or animals;

5. The term "herbal medicine" means raw drugs picked from animals, plants or minerals, and dried, cut or carefully prepared without changing the original forms in most cases;

6. The term "herbal medicinal product" means a medicinal product made by using herbal medicine according to the principle of Oriental medicine;

7. The term "quasi-drug" means an article designated by the Minister of Food and Drug

- 3 -

Safety, which falls under any of the following items (excluding the articles which shall be used for the purposes pursuant to subparagraph 4 (b) or (c)):

(a) Fibers, rubber products or similar products used for the purpose of treating, alleviating, or preventing human or animal diseases;

(b) Non-appliance, non-machinery or similar articles which act slightly upon or do not directly act upon human bodies;

(c) Preparations used for sterilization, insecticide and uses similar thereto for the purpose of preventing communicable diseases;

8. The term "new drug" means a medicinal product of new materials, the chemical structure or the construction of substance of which is wholly new, or a medicinal product of composite medication containing new materials as effective ingredients, which is designated by the Minister of Food and Drug Safety;

9. The term "non-prescription drug" means a medicinal product that falls under any of the following items and conforms to the standards prescribed and announced by the Minister of Food and Drug Safety after consultation with the Minister of Health and Welfare:

(a) A medicinal product, the misuse or the abuse of which is of little concern, and the safety and efficacy of which may be expected even when used without a prescription by a doctor or a dentist;

(b) A medicinal product that may be used to cure a disease without doctor's or dentist's professional knowledge;

(c) A medicinal product that has a relatively small side effect on human bodies in light of their dosage form and pharmacological action;

10. The term "prescription drug" means a medicinal product that is not an over-the-counter drug;

11. The term "preparation of drug" means preparing medicinal products to use for the purposes of treatment, prevention, etc. of a certain disease for a specific individual in accordance with the specific directions by preparing two or more medicinal products or by dividing one kind of medicinal product into certain dosages as a certain prescription dictates;

12. The term "guidance on taking drug" means those falling under any of the following items:

(a) Providing information on the name, directions for use and volume, efficacy and effect, storage methods, side effects and interactions, etc. of medicinal products;

(b) Assisting buyers in choosing necessary medicinal products without passing diagnostic judgment when selling over-the-counter drugs;

13. The term "safety container or package" means a container or package designed and devised to be difficult for children under five years of age to open;

14. The term "contract manufacturing and sales business" means business manufacturing medicinal products of which has been obtained from the Minister of Food and Drug Safety without manufacturing facilities by entrustment of medicinal product manufacture with a medicinal product manufacturer.

- 4 -

15. The term "clinical demonstration" means a test conducted on persons to verify pharmacokinetic, pharmacodynamic, pharmacological, and clinical effects of the relevant medicinal products, etc. and to examine abnormal reactions, in order to prove the safety and effectiveness of medicinal products, etc.

16. The term "non-clinical demonstration" means a test conducted under the same condition as a laboratory using an animal, a plant, a microorganism, a physical or chemical agent, or a thing consisting of components thereof in order to obtain various kinds of data on the nature or safety of a tested material which influences human health;

17. The term "biological equivalence test" means a medical experiment using a living body conducted to prove biological equivalence, and which shows that bioavailability of two pharmaceutical preparations containing the same major components is statistically equal.

CHAPTER II PHARMACISTS AND ORIENTAL PHARMACISTS

SECTION 1 Qualification and Licenses

Article 3 (Qualification and Licenses of Pharmacists)

① Any person who desires to become a pharmacist shall obtain a license from the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② A license of a pharmacist under paragraph ① shall be granted to a person falling under any of the following subparagraphs: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932,

Jan. 18, 2010>

1. A person who has graduated from a college of pharmacy and received a bachelor's degree in pharmacy, and passed a national examination for pharmacists;

2. A person who has graduated from a foreign college of pharmacy, accredited by the Minister of Health and Welfare, obtained a foreign license of a pharmacist, and passed a national examination for pharmacists.

③ Any person who has not obtained a pharmacist license shall be prohibited from using the title of "pharmacist".

Article 4 (Qualification and Licenses of oriental pharmacists)

① Any person who desires to become a oriental pharmacist shall obtain a license from the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② A license of a oriental pharmacist under paragraph ① shall be granted to a person who has majored in herb pharmacy in a college, received a bachelor's degree in herb pharmacy, and passed a national examination for oriental pharmacists.

③ Any person who has not obtained a license of a oriental pharmacist shall be prohibited

- 5 -

from using the title of "oriental pharmacist".

Article 5 (Disqualification)

No license of pharmacist or oriental pharmacist shall be given to a person falling under any of the following subparagraphs: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 11118, Dec. 2,

2011; Act No. 11251, Feb. 1, 2012>

1. A mental patient under subparagraph 1 of Article 3 of the Mental Health Act: Provided, That this shall not apply to a person who is recognized by a medical specialist to be suitable for taking charge of pharmaceutical affairs;

2. A person who has been adjudicated incompetent or quasi-incompetent;3. Persons addicted to narcotics, marijuana, or psychotropic drugs;4. A person who has been sentenced to imprisonment without prison labor or a heavier

penalty on charges of violating the Pharmaceutical Affairs Act, the Act on the Control of Narcotics, etc., the Act on Special Measures for the Control of Public Health Crimes, the Medical Service Act, Article 347 of the Criminal Act (limited to the case of deceiving patients or an institution or organization paying the medicinal product expenses by demanding the medicinal product expenses by falsity; hereinafter the same shall apply) and other Acts and subordinate statutes related to pharmaceutical affairs and for whom the sentence has yet to be terminated or exemption from its execution has yet to be made definite; or

5. A person who has been subjected to a disposition of cancellation of his/her license by committing the crimes under Article 347 of the Criminal Act and for whom 3 years have not elapsed, or subjected to a disposition of cancellation of his/her license by violating Acts and subordinate statutes relating to pharmaceutical affairs and for whom 2 years have not elapsed.

Article 6 (Issuance and Registration of Licenses)

① When the Minister of Health and Welfare issues a pharmacist's or oriental pharmacist's license, he/she shall register matters relating to the license in the relevant registry and issue the license concerned. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② If a license referred to in paragraph ① has been lost or damaged, or the matters stated therein have been changed, a new license may be issued in lieu thereof.

③ No license shall be lent to any other person.④ Matters necessary for registration of a pharmacist's or oriental pharmacist's license and

issuance thereof shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 7 (reporting by Pharmacists or oriental pharmacists)

Each pharmacist or oriental pharmacist shall report matters to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011>

- 6 -

Article 8 (National Examinations for Pharmacists or oriental pharmacists)

① National examinations for pharmacists or oriental pharmacists shall be conducted by the Minister of Health and Welfare at least once a year. <Amended by Act No. 88562, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010>

② The Minister of Health and Welfare may commission relevant specialized institutions recognized as competent to administer national examinations for pharmacists or oriental pharmacists referred to in paragraph ①, as prescribed by Presidential Decree. <Amended by

Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

③ The Minister of Health and Welfare may, when he/she commissions specialized institutions to administer national examinations under paragraph ②, subsidize necessary expenses. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

④ Matters necessary for national examinations for pharmacists or oriental pharmacists shall be prescribed by Presidential Decree.

Article 9 (Restrictions on Application for Examination)

Persons falling under subparagraphs 1 through 3 of Article 5 shall not apply for the national examination for pharmacists or oriental pharmacists.

Article 10 (Cheating of Examinee)

① Any person who has cheated in a national examination for pharmacists or oriental pharmacists shall be suspended from taking the examination, and where the fact of cheating is found after a candidate has passed the examination, the pass shall be nullified.

② The Minister of Health and Welfare may disallow persons falling under paragraph ① to apply for a national examination for pharmacists or oriental pharmacists, for two years. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

SECTION 2 Pharmaceutical Association and oriental pharmacy association

Article 11 (Pharmaceutical Association)

① Pharmacists shall establish the Korean Pharmaceutical Association (hereinafter referred to as the "Pharmaceutical Association") under the conditions as prescribed by Presidential Decree to research pharmaceutical affairs, establish pharmacists' ethics, promote the pharmacists' interests and elevate their quality.

② The Pharmaceutical Association shall be a juristic person.③ When the Pharmaceutical Association is established, pharmacists shall naturally become its

members.④ The provisions of the Civil Act relating to the corporate juridical person, in addition to

those of this Act, shall apply mutatis mutandis to the Pharmaceutical Association.

- 7 -

⑤ The Pharmaceutical Association shall establish the Ethics Committee in order to deliberate on and resolve requests for the disposition of qualification suspension under Article 79-2. <Newly Inserted by Act No. 10788, Jun. 7, 2011>

⑥ Matters concerning the organization and operation of the Ethics Committee shall be prescribed by Presidential Decree. <Newly Inserted by Act No. 10788, Jun. 7, 2011>

Article 12 (oriental pharmacy association)

① Oriental pharmacists shall establish the Association of Korea Oriental Pharmacy (hereinafter referred to as the "oriental pharmacy association") under the conditions as prescribed by Presidential Decree to research pharmaceutical affairs in connection with herb and herbal medicinal product, establish oriental pharmacists' ethics, promote the oriental pharmacists' interests and elevate their quality.

② The oriental pharmacy association shall be a juridical person.③ When the oriental pharmacy association is established, oriental pharmacists shall naturally

become its members.④ The provisions of the Civil Act concerning a corporate juridical person, in addition to those

as provided in this Act, shall apply mutatis mutandis to the oriental pharmacy association.⑤ The oriental pharmacy association shall establish the Ethics Committee in order to deliberate

on and resolve requests for the disposition of qualification suspension under Article 79-2. <Newly Inserted by Act No. 10788, Jun. 7, 2011>

⑥ Matters concerning the organization and operation, etc. of the Ethics Committee shall be prescribed by Presidential Decree. <Newly Inserted by Act No. 10788, Jun. 7, 2011>

Article 13 (Authorization, etc.)

① When the Pharmaceutical Association or oriental pharmacy association is established, the articles of association and other necessary documents shall be submitted to the Minister of Health and Welfare and authorization from him/her shall be obtained, as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② Matters to be stated in the articles of association by the Pharmaceutical Association or by the oriental pharmacy association shall be prescribed by Presidential Decree.

③ If the Pharmaceutical Association or oriental pharmacy association intends to amend its articles of association, it shall obtain authorization therefor from the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 14 (Chapters, etc. of Pharmaceutical Association and oriental pharmacy

association)

① The Pharmaceutical Association or oriental pharmacy association shall establish its chapters in the Special Metropolitan City, Metropolitan Cities, Dos and Special Self-Governing Province (hereinafter referred to as "City/Do"), and may establish branches in the Gus and Sis of the Special Metropolitan City and Metropolitan Cities (referring to an administrative si in cases of special self-governing provinces; hereinafter the same shall apply) and Guns

- 8 -

thereof. <Amended by Act No. 10788, Jun. 7, 2011>

② When the Pharmaceutical Association or oriental pharmacy association has established its chapters and branches, it shall, without delay, file a report thereof with the Special Metropolitan City Mayor, Metropolitan City Mayors, Do governors or Special Self-Governing Province's Do governor (hereinafter referred to as "Mayor/Do governor").

Article 15 (Training and Education)

① The Minister of Health and Welfare may order pharmacists and oriental pharmacists to undergo training and education for the improvement of their quality. <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② Necessary matters concerning training and education under paragraph ① shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010>

Article 16 (Duties of Cooperation and entrustment)

① The Pharmaceutical Association or oriental pharmacy association shall comply with a request for cooperation of the Minister of Health and Welfare concerning projects for the improvement of national public health, pharmaceutical affairs, and pharmacists' or oriental pharmacists' ethics. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② The Minister of Health and Welfare may entrust some of matters concerning pharmaceutical affairs and pharmacists' or oriental pharmacists' ethics to the Pharmaceutical Association or oriental pharmacy association, as prescribed by Presidential Decree. <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 17 (Subsidization of Expenses)

When the Minister of Health and Welfare deems that the programs of the Pharmaceutical Association or oriental pharmacy association are necessary for the improvement of national public health, or when he/she has ordered or entrusted such Association to conduct training for pharmacists or oriental pharmacists, investigation and research, he/she may fully or partially subsidize necessary expenses. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18,

2010>

CHAPTER III PHARMACEUTICAL AFFAIRS COUNCIL

Article 18 (Central Pharmaceutical Affairs Council)

① A Central Pharmaceutical Affairs Council shall be established under the control of the Minister of Food and Drug Safety in order to provide the Minister of Health and Welfare and the Minister of Food and Drug Safety with advices when requested. <Amended by Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

- 9 -

② Matters necessary for the organization and operation of the Central Pharmaceutical Affairs Council and other necessary matters, shall be prescribed by Presidential Decree.

Article 19 Deleted. <by Act No. 10512, Mar. 30, 2011>

CHAPTER IV PHARMACIES AND PREPARATION OF DRUGS

SECTION 1 Pharmacies

Article 20 (Registration for Establishment of Pharmacies)

① No person, other than a pharmacist or oriental pharmacist, shall establish a pharmacy.② Any person intending to establish a pharmacy shall file for registration for establishment

with the head of a Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply), as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall apply in cases of any amendment to the registered matters. <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

③ Any person desiring to file for registration under paragraph ② shall install necessary facilities in conformity with the standards of facilities prescribed by Presidential Decree.

④ A Mayor/Do Governor may set the standards of registration for establishing a pharmacy, respectively by the regulations of the relevant City/Do in conformity with the standards prescribed by Presidential Decree.

⑤ In cases falling under any of the following subparagraphs, no application for the registration for establishment of a pharmacy shall be accepted:1. Where a person whose registration for establishment of a pharmacy has been cancelled

pursuant to Article 76 intends to register within six months from the date of cancellation;

2. Where a pharmacy is to be established in a place which is located within facilities or premises of a medical institution;

3. Where a pharmacy is established by dividing, altering or repairing part of facilities or sites of a medical institution;

4. Where a pathway, such as an exclusive corridor, a flight of stairs, an elevator or a footbridge, is in place or to be constructed between a pharmacy and a medical institution.

Article 21 (Duties to Manage Pharmacies)

① A pharmacist or oriental pharmacist may establish only one pharmacy.② Any pharmacy founder shall manage the pharmacy in person: Provided, That where a

pharmacy founder is unable to run the pharmacy, he/she shall designate a pharmacist or a

- 10 -

oriental pharmacist to run such pharmacy on behalf of him/her.③ Every pharmacist or oriental pharmacist who manages a pharmacy shall observe the

following matters necessary to manage such pharmacy: <Amended by Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

1. He/she shall manage his/her pharmacy and medicinal products in a manner not inflicting harm to health and sanitation and to keep the efficacy of medicinal products therein from falling;

2. He/she shall thoroughly oversee his/her employees in order to prevent any sanitary incident;

3. He/she shall keep any goods feared to incur any sanitary danger off from his/her pharmacy;

4. In the event that any adverse reaction, etc. occurs in connection with the use of medicinal products, etc., he/she shall take necessary safety steps;

5. He/she shall observe other matters corresponding to the provisions of subparagraphs 1 through 4 and recognized by Ordinance of the Ministry of Health and Welfare after consultation with the Minister of Food and Drug Safety as necessary to manage the facilities and medicinal products of pharmacies in a manner not inflicting harm to health and sanitation.

Article 22 (reporting on Discontinuation of Business, etc.)

Where a pharmacy founder discontinues the business of running the pharmacy, or suspends such business or resumes the suspended business, he/she shall file a report thereon with the head of a Si/Gun/Gu having jurisdiction over his/her business within seven days from the date of discontinuation, suspension or resumption, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That the same shall not apply in cases where a period for business suspension is less than one month. <Amended by Act No. 8852, Feb. 29, 2008; Act No.

9932, Jan. 18, 2010>

SECTION 2 Preparation of Drugs

Article 23 (Preparation of Drugs)

① No person, other than pharmacists or oriental pharmacists, may prepare medicinal products, and pharmacists or oriental pharmacists shall prepare medicinal products within the limit of the license, respectively: Provided, That students who major in pharmacy at college may prepare medicinal products within the limits prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② When a pharmacist or oriental pharmacist is to prepare medicinal products, he/she shall do so at a pharmacy or a dispensary of a medical institution (including a dispensary installed in the Korea Orphan Drug Center pursuant to the latter part of Article 92 ① 2): Provided, That this shall not apply in cases where he/she has obtained approval from the head of a

- 11 -

Si/Gun/Gu.③ Any doctor or dentist shall be entitled to prescribe prescription drugs and non-prescription

drugs and any pharmacist shall be entitled to prepare prescription drugs and non-prescription drugs according to the prescriptions issued by doctors or dentists: Provided, That a pharmacist may prepare medicinal products without prescriptions issued by a doctor or dentist in cases falling under any of the following subparagraphs: <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9847, Dec. 29, 2009; Act No. 9932, Jan. 18, 2010>

1. Where he/she prepares medicinal products in an area where no medical institution exists;2. Where he/she prepares medicinal products for the purpose of disaster relief after a

natural disaster renders medical institutions virtually nonexistent;3. Where he/she sells oral vaccines to prevent spread of a communicable disease after the

Minister of Health and Welfare recognizes that such communicable disease has broken out or is feared to break out widely;

4. Where he/she prepares medicinal products for social service activities.④ Notwithstanding the provisions of paragraph ①, a doctor or dentist may directly prepare

medicinal products, in any of the following cases: <Amended by Act Nos. 8723 & 8728, Dec.

21, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9819, Nov. 2, 2008; Act No. 9847, Dec. 29, 2009; Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011>

1. Where he/she prepares medicinal products in an area where no pharmacy exists;2. Where he/she prepares medicinal products for the purpose of disaster relief after a

natural disaster renders pharmacies virtually nonexistent;3. Where he/she prepares medicinal products for an emergency patient or a mental patient

suffering from schizophrenia or a manic-depressive insanity, etc. who is feared to harm himself/herself and others;

4. Where he/she prepares drugs for an in-patient, a patient suffering from a Type 1 communicable disease under the Communicable Disease Control and Prevention Act or a person admitted to a social welfare facility under the Social Welfare Services Act (in cases where the person does not board and lodge in such facility, it shall be limited only to the preparation of drugs during a period for which he/she utilizes such facility);

5. Where he/she gives injections;6. Where he/she makes dosages of vaccines to prevent communicable diseases, medicinal

products for medical examinations and other medicinal products, etc. prescribed by Ordinance of the Ministry of Health and Welfare;

7. Where he/she, while serving in a public health center or its branch office under the Regional Public Health Act, prepares medicinal products for patients, as performance of his/her duties (excluding treatment of visiting residents within the jurisdiction of a public health center and a public health branch office designated by the Minister of Health and Welfare);

8. Where he/she prepares medicinal products for veterans suffering from wound-rating I through III under the Act on the Honorable Treatment and Support of Persons, etc. of Distinguished Services to the State and its Enforcement Decree, persons suffering from

- 12 -

wound-rating I through IV among those who were wounded in the 5․18 Democratization Movement under the Act on the Honorable Treatment of Persons of Distinguished Services to the 5․18 Democratization Movement, highly handicapped persons under the Act on Assistance, etc. to Patients from Actual or Potential Aftereffects of Defoliants and its Enforcement Decree, grades I and II handicapped persons under Acts and subordinate statutes related to the welfare of handicapped persons, handicapped persons equivalent thereto, and patients suffering from Parkinson's disease or Hansen's disease;

9. Where he/she prepares medicinal products for the treatment of persons having undergone the surgery of internal organ transplant and the treatment of patients suffering from AIDS;

10. Where he/she prepares medicinal products for the active service persons in the course of discharging military duty, combat police officers, guards of any correctional institution and other persons who are held in prison facilities under the Administration and Treatment of Correctional Institution Inmates Act and the Administration and Treatment of Military Inmates Act, protected juvenile accommodation facilities under the Treatment of Protected Juveniles, etc. Act and foreigner protection facilities under the Immigration Control Act;

11. Where he/she makes dosages of medicinal products for the treatment of tuberculosis under the Tuberculosis Prevention Act (limited to public health centers, public health branches and affiliated hospitals of the Korean National Tuberculosis Association);

12. Where he/she prepares medicinal products for social service activities;13. Where prescriptions are prohibited from being made public for the sake of the

preservation of information related to the national security;14. Other cases prescribed by Presidential Decree.

⑤ The scope of the area where no medical institution or pharmacy exists, as referred to in paragraph ③ 1 or ④ 1, shall be determined by the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010 >

⑥ When a oriental pharmacist prepares any herb drug, he/she shall comply with the prescription of a herb doctor: Provided, That in cases where he/she prepares it according to the category of herb drug prescription or method of preparation determined by the Minister of Health and Welfare, he/she may prepare it without prescription of a herb doctor. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

⑦ Any pharmacist engaging in the preparation of drugs at a dispensary of a medical institution shall be prohibited from preparing any medicinal product for a patient to whom a prescription is issued under Article 18 of the Medical Service Act.

Article 24 (Duties and Matters to be Observed)

① No pharmacist or oriental pharmacist engaging in the preparation of drugs at a pharmacy, shall refuse any request for preparing medicinal products, without justifiable grounds.

② Any pharmacy founder (including persons working for the relevant pharmacy; hereafter the same shall apply in this Article) and any medical institution founder (including persons

- 13 -

working for the relevant medical institution; hereafter the same shall apply in this Article) shall be prohibited from engaging in any of the following collusive acts:1. The act, performed by any pharmacy founder, of wholly or partially exempting medicinal

product expenses for any person carrying a medical prescription written by a specific medical institution;

2. The act, performed by any pharmacy founder, of offering money, articles, favors, labor, entertainment and other economic interest in return for medical prescriptions arranged by a specific medical institution founder in favor of him/her;

3. The act, performed by any medical institution founder, of directing or inducing any person carrying its medical prescription to get such medical prescription prepared at a specific pharmacy (excluding the act of introducing in full the names, locations, etc. of pharmacies in the relevant area at the request of any patient);

4. The act, performed by any doctor or dentist, of repeatedly prescribing other medicinal products that are identical in composition to the medicinal products that are included in the list of medicinal products for prescription provided by the branches of the Medical Association or the branches of the Dental Association to the branches of the Pharmaceutical Association under Article 25 ② (the same shall apply to any pharmacist who repeatedly prepares the relevant medicinal products according to the relevant medical prescription);

5. Any other act similar to that referred to in subparagraphs 1 through 4 and prescribed by Presidential Decree as having the potential of collusion.

③ Any pharmacist or oriental pharmacist working at a dispensary of a medical institution under Article 23 ② shall, when he/she prepares medicinal products, observe matters prescribed by Ordinance of the Ministry of Health and Welfare after consultation with the Minister of Food and Drug Safety. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932,

Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

④ Every pharmacist shall, when he/she prepares medicinal products for any patient, give the guidance on taking such medicinal products to the relevant patient.

⑤ The Minister of Health and Welfare may take necessary steps to get pharmacists to faithfully offer patients the guidance on taking medicinal products provided for in paragraph ④ through the preparation of a proper number of medical prescriptions. <Amended by Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 25 (Drawing Up, etc. of List of Medicinal Products for Prescription)

① Any medical institution founder shall submit a list of medicinal products that the relevant medical institution intends to prescribe to the branch of the Medical Association or the branch of the Dental Association (hereinafter referred to as the "branch of the Medical Association, etc."), which has been established pursuant to Article 28 ⑤ of the Medical Service Act, of the Si/Gun/Gu where such medical institution is located.

② The branch of the Medical Association, etc. shall provide the branch of the Pharmaceutical Association of the relevant Si/Gun/Gu with a regional list of medicinal products to

- 14 -

prescribe which has been obtained by adjusting the list of medicinal products to prescribe by medical institutions pursuant to paragraph ① to a reasonable number of articles and a list of medicinal products to prescribe by medical institutions which has been obtained by adjusting within the extent of the medicinal products in the regional list of medicinal products to prescribe.

③ The branch of the Pharmaceutical Association shall, upon receiving the regional list of medicinal products to prescribe and the list of medicinal products to prescribe by medical institutions from the branch of the Medical Association, etc. under paragraph ②, furnish pharmacy founders in the relevant area with such lists and have them secure relevant medicinal products.

④ In the event that any pharmacy founder finds it difficult to secure medicinal products according to the list of medicinal products to prescribe referred to in paragraph ② and that it becomes necessary to adjust the number of articles, the branch of the Medical Association, etc. and the branch of the Pharmaceutical Association may adjust it through consultations. The same shall apply to a case where the numbers of articles are added or altered.

⑤ The branch of the Medical Association, etc. shall, if it intends to alter or add the list of medicinal products to prescribe referred to in paragraph ②, file a notice to that effect with the branch of the Pharmaceutical Association 30 days in advance.

Article 26 (Modification and Revision of Prescriptions)

① No pharmacist or oriental pharmacist shall prepare medicinal products by modifying or revising prescriptions without the consent of the doctor, dentist, herb doctor or veterinarian who has made the prescriptions.

② In cases where a name, quantity, directions, dose, etc. of a medicinal product written in a prescription is suspected to fall under any of the following subparagraphs, a pharmacist or oriental pharmacist shall not prepare medicinal products unless he/she has confirmed any suspect points by telephone and fax or by telephone and e-mail with the doctor, dentist, herb doctor or veterinarian who has issued the prescription: <Amended by Act No. 8558, Jul.

27, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

1. In cases where a medicinal product, product approval and product registration of which has been revoked by the Minister of Food and Drug Safety because of the problem in safety and effectiveness of the medicinal product, is written in the prescription;

2. In cases where it is unable to confirm a name of item or a name of composition of a medicinal product;

3. In cases where a medicinal product, which has been announced by the Minister of Food and Drug Safety as contraction of use in combination or as composition of contraction in specific age bracket pursuant to the basis of medical treatment benefit prescribed by Ordinance of the Ministry of Health and Welfare pursuant to Article 41 ② of the National Health Insurance Act, is written in the prescription.

- 15 -

③ Detailed matters, such as the method of and procedures for revising and modifying prescriptions under paragraph ①, shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852. Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 27 (Preparing Substitute Medicinal Products)

① When a pharmacist intends to prepare a medicinal product by substituting the medicinal product in a prescription slip issued by a doctor or dentist with a medicinal product of the same composition, content and dosage form, he/she shall obtain prior consent of the doctor or dentist who has issued the prescription slip.

② Notwithstanding the provisions of paragraph ①, a pharmacist may prepare a substitute medicinal product without obtaining prior consent of the doctor or dentist who has issued the prescription slip where it falls under any of the following subparagraphs: <Amended by

Act No. 11690, Mar. 23, 2013>

1. Where the pharmacist prepares a substitute medicinal product which has been recognized by the Minister of Food and Drug Safety as having biological equivalence (including medicinal products that prove their biological equivalence through a medical experiment using no living body because of the needlessness to conduct a medical experiment using a living body or of the impossibility to do so): Provided, That in case where the doctor or dentist has indicated in the prescription slip that the preparation of a substitute medicinal product is not permissible, and has written in detail the clinical reasons, etc. therefor, such article shall be excluded;

2. Where the pharmacist prepares a substitute medicinal product with the same prescription dosage, which has been manufactured by the same medicinal product manufacturer who also manufactures the medicinal product stated in the prescription slip, and which is different in content but is of the same composition and dosage form: Provided, That the preparation of such substitute medicinal product shall be limited only to cases where a substitute non-prescription drugs is prepared in place of non-prescription drugs and a substitute prescription drug is prepared in place of a prescription drug;

3. Where there is an unavoidable reason for which it is difficult to obtain prior consent of the doctor or dentist who has issued the prescription slip in cases where the medicinal product stated in the prescription slip, which has been issued by a medical institution located in a region, other than a Si/Gun/Gu in which the pharmacy is located, is not included in the regional list of medicinal products to prescribe, and the preparation is substituted by a medicinal product of the same composition, content and dosage form as the medicinal product stated in the prescription slip in the regional list of medicinal products to prescribe of the pharmacy concerned.

③ Every pharmacist shall, if he/she prepares a substitute medicinal product instead of the medicinal product stated in a prescription slip under paragraph ① or ②, notify the person carrying such prescription slip of the detail of such substitute medicinal product that has been prepared.

④ Every pharmacist shall, if he/she prepares a substitute medicinal product instead of the

- 16 -

medicinal product entered in a prescription slip under paragraph ②, notify the doctor or dentist who has issued such prescription slip of the details of such substitute medicinal product that has been prepared within one day from the date of preparation (within three days if extenuating circumstances exist): Provided, That the same shall not apply in cases where the pharmacist prepares such substitute medicinal product after obtaining prior consent of the doctor or dentist who has issued the prescription slip thereof.

⑤ Where any pharmacist prepares a substitute medicinal product instead of the medicinal product entered in a prescription slip without prior consent of the doctor or dentist who has issued such prescription slip, such doctor or dentist shall not be held responsible for any medicinal product accident caused by such substitute medicinal product.

⑥ Necessary matters concerning methods of and procedures for obtaining consent and providing notice, etc. under paragraphs ① and ④ shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan.

18, 2010>

Article 28 (Indication and Recording of Prepared Medicinal Products)

① A pharmacist or oriental pharmacist shall indicate the relevant patient's name, directions, and dose mentioned in the pertinent prescription slip and other matters prescribed by Ordinance of the Ministry of Health and Welfare on the containers or packages of medicinal products prepared for sale. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② When a pharmacist or oriental pharmacist has prepared medicinal products, he/she shall indicate in the prescription slip, the date of preparation and other matters prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008;

Act No. 9932, Jan. 18, 2010>

Article 29 (Preservation of Prescriptions)

The pharmacist or oriental pharmacist shall keep prescriptions by which he/she has prepared medicinal products at his/her pharmacy, for two years from the date of preparation.

Article 30 (Preparation Records)

① Whenever every pharmacist prepares medicinal products (including the cases where he/she prepares medicinal products without a prescription in accordance with the proviso to the partial provisions other than each subparagraph of Article 23 ③ and each paragraph of the said Article; hereafter the same shall apply in this Article) at his/her pharmacy, he/she shall enter the personal information of a patient, preparation date, the names of prescribed medicinal products and the days of taking medicinal products, details of preparation, details of guidance on taking medicinal products and other matters prescribed by Ordinance of the Ministry of Health and Welfare in his/her preparation records (including electronic records) and preserve such preparation records for five years. <Amended by Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011>

- 17 -

② Where any patient, his/her spouse, his/her lineal ascendant or descendant, or his/her spouse's lineal ascendant (an agent designated by such patient in cases where his/her spouse, his/her lineal ascendant or descendant and his/her spouse's lineal ascendant are all nonexistent) requests a perusal of the preparation records preserved under paragraph ①, an issuance of a copy of such preparation records and a confirmation of details of such preparation records, etc., he/she shall comply with such request.

CHAPTER V MANUFACTURE, IMPORTATION, ETC. OF MEDICINAL PRODUCTS, ETC.

SECTION 1 Manufacturing Business of Medicinal Products, etc.

Article 31 (Licensing of Manufacturing Business, etc.)

① A person who intends to engage in business of manufacturing medicinal products shall obtain license from the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister, after being equipped with necessary facilities pursuant to the standards for facilities prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act

No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② In cases where a manufacturer under paragraph ① intends to sell medicinal products manufactured (including cases of contracting another manufacturer with manufacture), he/she shall obtain product approval of manufacture and sale (hereinafter referred to as "product approval") by item from the Minister of Food and Drug Safety or apply for a product registration of manufacture and sale (hereinafter referred to as "product registration"), as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

③ In cases where a person, other than a manufacturer under paragraph ①, intends to entrust a manufacturer with manufacture of a medicinal product which has been put to clinical demonstrations after having obtained permission of plans of clinical demonstrations pursuant to Article 34 ① and sell it, he/she shall apply for registration on contract manufacturing and sales business to the Minister of Food and Drug Safety and obtain product approval by item, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

④ A person who intends to engage in business of manufacturing quasi-drugs shall apply for a product registration on manufacture business to the Minister of Food and Drug Safety after being equipped with necessary facilities pursuant to the standards for facilities prescribed by Presidential Decree, and obtain product approval or apply for a product registration by item. <Amended by Act No. 11690, Mar. 23, 2013>

⑤ A person who has obtained product approval or has applied for a product registration pursuant to paragraphs ② and ③ (hereinafter referred to as "person who has obtained product approval") may establish a business office, as prescribed by Ordinance of the Prime

- 18 -

Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690,

Mar. 23, 2013>

⑥ Notwithstanding paragraphs ① through ④, license of manufacture business, product approval, or product registration of medicinal product items may not be required for the medicinal products or quasi-drugs (hereinafter referred to as "medicinal products, etc.") prescribed by Ordinance of the Prime Minister, such as medicinal products for clinical demonstrations under Article 34. <Newly Inserted by Act. No. 10512, Mar. 30, 2011; Act No.

11690, Mar. 23, 2013>

⑦ Notwithstanding paragraphs ② through ④, a product or an item, in which medicinal products, etc. and a medical device are combined together or they are complexly made and which has been approved or registered pursuant to the Medical Devices Act because its major function is a medical device, shall be deemed obtained product approval or applied for a registration of medicinal products pursuant to paragraphs ② through ④. <Newly

Inserted by Act. No. 10512, Mar. 30, 2011>

⑧ No person who falls under any of the following subparagraphs shall obtain approval nor apply for a registration on manufacture business or contract manufacturing and sales business of medicinal products, etc.: <Amended by Act. No. 10512, Mar. 30, 2011>

1. A person falling under any subparagraph of Article 5;2. A person in whose case one year has not passed since the revocation of approval of

manufacture business or closure of an office of a contract manufacturing and sales business or a factory pursuant to Article 76;

3. A person who was declared bankrupt and has not been reinstated.⑨ In cases under paragraphs ① through ④, when intending to change the approved or

registered matters prescribed by Ordinance of the Prime Minister, he/she shall obtain approval for a change or apply for a registration on a change, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act. No. 10512, Mar. 30,

2011; Act No. 11690, Mar. 23, 2013>

⑩ If a medicinal product to be approved or registered pursuant to paragraphs ② and ③, is a new drug or a medicinal product designated by the Minister of Food and Drug Safety, the following documents related to its safety and efficacy shall be submitted, as prescribed by Ordinance of the Prime Minister: Provided, That subparagraph 2 shall be excluded, if active pharmaceutical ingredients(APIs) has been registered pursuant to Article 31-2: <Amended by Act No. 8852, Feb. 29, 2008; Act. No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>

1. Test results and their relevant data; 2. Data on active pharmaceutical ingredients(APIs); 3. Relevant literature; 4. Other necessary data.⑪ When obtaining approval or registration on manufacture business, contract manufacturing and

sales business and items of manufacture and sale of medicinal products, etc. under paragraphs ① through ④ and ⑨, matters necessary for the items, standards, conditions, management, etc. of approval or registration shall be prescribed by Ordinance of the Prime

- 19 -

Minister. <Amended by Act No. 8852, Feb. 29, 2008; <Amended by Act. No. 10512, Mar. 30,

2011; Act No. 11690, Mar. 23, 2013> [This Article Wholly Amended by Act No. 8643, Oct. 17, 2007]

Article 31-2 (Registration, etc. of Active Pharmaceutical Ingredients (Drug Master

file))

① A person who intends to manufacture and sell active pharmaceutical ingredients of a new drug or active pharmaceutical ingredients which was determined and notified by the Minister of Food and Drug Safety may register the matters prescribed by Ordinance of the Prime Minister, such as its substances, name and manufacturing methods, to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Amended by Act

No. 11690, Mar. 23, 2013> ② The Minister of Food and Drug Safety shall review whether the registered matters under

paragraph ① satisfy the criteria prescribed by Ordinance of the Prime Minister, inform the relevant applicant of the review results, record the review details in the active pharmaceutical ingredient register, and keep the register. In such cases, he/she shall publicly notify the matters prescribed by Ordinance of the Prime Minister, such as the substances and manufacturer, etc. of the corresponding active pharmaceutical ingredient. <Amended by

Act No. 11690, Mar. 23, 2013>

③ A person, who intends to alter the important matters prescribed by Ordinance of the Prime Minister from among the matters registered pursuant to paragraphs ① and ②, shall make alteration registration to the Minister of Food and Drug Safety: Provided, That a person who intends to alter matters other than such matters shall make a report. <Amended by Act

No. 11690, Mar. 23, 2013>

④ The medicinal product substance registered pursuant to paragraphs ① through ③ shall be deemed obtained product approval or registration under Article 31 ②.

⑤ Matters necessary for making registration and alteration registration of or an alteration report on medicinal product substance and for giving a public notice of registered medicinal product substance, etc., other than the matters prescribed in paragraphs ① through ③, shall be determined by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23,

2013> [This Article Newly Inserted by Act No. 10512, Mar. 30, 2011]

Article 31-3 (Patent List of Medicinal Products)

① If a person who has obtained product approval of medicinal products pursuant to Article 31 ② or ③ desires to have the matters prescribed by Ordinance of the Prime Minister, such as an owner of a patent right, duration, and the extent of the patent of the medicinal products which obtained product approval, (hereinafter referred to as "patent information") listed in the patent list for medicinal products (hereinafter referred to as "patent list"), he/she shall file an application for registration with the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

- 20 -

② If the patent of a medicinal product registration of which was applied for pursuant to paragraph ① satisfies the subjects and standards determined by Ordinance of the Prime Minister, the Minister of Food and Drug Safety shall register the patent information of the relevant medicinal product in the patent list. <Amended by Act No. 11690, Mar. 23, 2013>

③ If a person who has obtained product approval of the medicinal product registered in the patent list pursuant to paragraph ② (hereinafter referred to as "registered medicinal product") desires to alter the patent information registered in the patent list, he/she shall file an application for altering registration with the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

④ The Minister of Food and Drug Safety shall ascertain the details of the application for altering registration under paragraph ③, and if the details are deemed appropriate, he/she shall alter the patent information registered in the patent list. <Amended by Act No. 11690,

Mar. 23, 2013>

⑤ Where the patent on the registered medicinal product fails to meet the subjects and standards referred to in paragraph ②, the Minister of Food and Drug Safety may delete from the patent list or change the patent information on the registered medicinal product by his/her authority. In such cases, the Minister of Food and Drug Safety shall hear, in advance, opinions of the person who has obtained product approval of the relevant registered medicinal product. <Amended by Act No. 11690, Mar. 23, 2013>

⑥ If the Minister of Food and Drug Safety has registered the patent information on medicinal products in the patent list, or deleted or changed the patent information on registered medicinal products, he/she shall publicly notify the details on the Internet homepage. <Amended by Act No. 11690, Mar. 23, 2013>

⑦ Except as prescribed in paragraphs ① through ⑥, matters on the registration in the patent list, deletion and alteration of the registered patent information, and the procedures and methods for the public notice of the patent list and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 11118, Dec. 2, 2011]

Article 31-4 (Notice of Fact of Application for product approval)

① A person who has applied for product approval of medicinal products under Article 31 ② or ③ based on the data on the safety and effectiveness of the registered medicinal products shall inform the person who has obtained product approval of the registered medicinal products and the owner of the patent right (hereinafter referred to as "owner of the patent right, etc.") of the matters prescribed by Ordinance of the Prime Minister, such as the fact that he/she applied for product approval: Provided, That the same shall not apply to any of the following cases: <Amended by Act No. 11690, Mar. 23, 2013>

1. Where the duration of the patent of a registered medicinal product has ended; 2. Where an application for product approval has been made to sell a relevant medicinal

product after the duration of the patent of a registered medicinal product ends; 3. Where the owner of the patent right, etc. of a registered medicinal product has agreed to

- 21 -

the failure to give notice; 4. Where the patent tribunal's trial decision or a court judgement exists that the patent of a

registered medicinal product is invalid, or that a medicinal product which applied for product approval is not included in the scope of the right to the patent of the registered medicinal product;

5. Cases corresponding to those in subparagraphs 1 through 4 which are prescribed by Ordinance of the Prime Minister.

② Matters necessary for the period, methods, and procedures of notice under paragraph ① and other matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No.

11690, Mar. 23, 2013> [This Article Newly Inserted by Act No. 11118, Dec. 2, 2011]

Article 31-5 (Renewal of Product Approval, etc. for Medicinal Products)

① The effective period of product approval and product registration for medicinal products referred to in Article 31 ② and ③ shall be 5 years: Provided, The effective period shall not apply to medicinal products falling under any of the following subparagraphs. <Amended by Act No. 11690, Mar. 23, 2013>

1. Active pharmaceutical ingredients;2. Medicinal products manufactured for export purpose only; 3. Medicinal products which are corresponding to the provisions of subparagraphs 1 and 2

and prescribed by Ordinance of the Prime Minister.② Notwithstanding the provisions of paragraph ①, the effective period of product approval for

medicinal products subject to re-examination pursuant to Article 32 shall apply after completion of re-examination period for the relevant medicinal products.

③ When a person who has obtained product approval intends to continue to sell the relevant medicinal products after termination of the effective period as prescribed in the provisions of paragraphs ① and ②, he/she shall renew product approval from the Minister of Food and Drug Safety or product registration prior to termination of the effective period. <Amended by Act No. 11690, Mar. 23, 2013>

④ In cases where a medicinal product has been recognized by the Minister of Food and Drug Safety because of the problem in safety and effectiveness of the medicinal product and where documents necessary for renewal pursuant to paragraph ③ has not submitted, etc., product approval or product registration for the relevant medicinal products may not be renewed. <Amended by Act No. 11690, Mar. 23, 2013>

⑤ No person who has obtained product approval shall renew product approval nor product registration under paragraph ③ for any medicinal products which has not manufactured within the effective period pursuant to paragraph ①: Provided, That the same shall not apply in cases where they have failed to be manufactured owing to extenuating circumstances prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690,

Mar. 23, 2013>

⑥ Matters necessary for calculation methods of effective period under paragraphs ① and ②

- 22 -

and for the standards, methods and procedures, etc. for renewal of product approval and registration under paragraphs ③ and ④ shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 11421, May. 14, 2012]

Article 32 (Re-Examination of New Drugs, etc.)

① Medicinal products under Article 31 ⑩, approval by item of which has been granted pursuant to Article 31 ② and ③ shall undergo a re-examination by the Minister of Food and Drug Safety, within three months after four to six years have passed from the date of approval. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10512, Mar. 30, 2011; Act No.

11690, Mar. 23, 2013>

② Matters necessary for method, procedure, time, etc. for re-examination referred to in paragraph ① shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 33 (Reevaluation of Medicinal Products)

① The Minister of Food and Drug Safety may reevaluate medicinal products for which examination of their safety and effectiveness by efficacy or ingredient or the verification of medicinal product equivalence are deemed necessary from among medicinal products for which approval or registration by item has been granted pursuant to Article 31 ② and ③. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 11690, Mar. 23, 2013>

② Matters necessary for method, procedure, etc. for reevaluation as referred to in paragraph ① shall be determined by the Minister of Food and Drug Safety. <Amended by Act No. 11690,

Mar. 23, 2013>

Article 34 (Permission of Plans for Clinical Demonstrations, etc.)

① Any person who intends to conduct a clinical demonstration or a biological equivalence test using medicinal products, etc. shall prepare a plan therefor and obtain approval thereof from the Minister of Food and Drug Safety. The same shall apply to cases where he/she intends to alter the approved clinical demonstration plan or biological equivalence test plan. <Amended by Act No. 11690, Mar. 23, 2013>

② Notwithstanding paragraph ①, the clinical demonstrations and biological equivalence tests prescribed by Ordinance of the Prime Minister (hereinafter referred to as "clinical demonstrations, etc."), such as a test aimed at examining clinical effects of medicinal products, etc.currently for sale and investigating whether any extraordinary reactions exist within the extent that product approval was obtained or a product registration was applied for, may not obtain approval under paragraph ①. <Amended by Act No. 11690, Mar. 23,

2013>

③ Any person who intends to conduct a clinical demonstration referred to in paragraph ① shall observe the following matters: <Amended by Act No. 11690, Mar. 23, 2013>

- 23 -

1. A clinical demonstration shall be conducted at a clinical demonstration institution or a biological equivalence test institution designated under Article 34-2 ①: Provided, That the same shall not apply to clinical demonstrations, etc. prescribed by Ordinance of the Prime Minister in which participation by a medical institution, other than by a clinical demonstration institution or a biological equivalence test institution, is deemed necessary considering the characteristics of the clinical demonstrations, etc;

2. No person who is accommodated by mass facilities prescribed by Ordinance of the Prime Minister, such as social welfare facilities, (hereinafter referred to as "inmates" in this subparagraph) shall be selected as subjects of clinical demonstrations, etc.: Provided, That inmates may be selected as subjects of clinical demonstrations, etc. in cases where it is inevitable to select inmates as subjects thereof, considering the characteristics of the clinical demonstration, etc. and which meet the criteria prescribed by Ordinance of the Prime Minister.

3. Details of a clinical demonstration, etc. and details of and procedures, etc. for an indemnity for any health damage that may be inflicted on a testee during the clinical demonstration, etc. shall be explained to the testee of the clinical demonstration, etc. and consent of the testee shall be obtained;

4. Medicinal products, etc. which were manufactured, or imported after being manufactured, in appropriate manufacturing facilities prescribed by Ordinance of the Prime Minister shall be used;

④ No medicinal products, etc. which were manufactured or imported after being manufactured for the purpose of clinical demonstrations, etc. shall be used for any purpose other than clinical demonstrations, etc.: Provided, That in cases where approval from the Minister of Food and Drug Safety has been obtained, as prescribed by Ordinance of the Prime Minister, to treat any of the following patients, the relevant medicinal products, etc. may be used for any purpose other than clinical demonstrations, etc. and in such cases, paragraph ③ 3 shall apply mutatis mutandis: <Amended by Act No. 11690, Mar. 23, 2013>

1. A patient with serious life-threatening disease, such as terminal cancer and AIDS;2. An emergency patient prescribed by Ordinance of the Prime Minister, such as a patient

whose life is being threatened and a patient without alternative means of treatment. ⑤ Where a clinical demonstration, etc. on pharmaceutical preparations, blood pharmaceutical

preparations, gene remedial agents and cell remedial agents, etc., which contain questionable composition in light of safety or effectiveness, is deemed or feared to harm the public interest or health and sanitation, the Minister of Food and Drug Safety may place limits on such clinical demonstration, etc. which is subject to approval under paragraph ①. <Amended by Act No. 11690, Mar. 23, 2013>

⑥ Where any clinical demonstration, etc. approval for which has been granted under the former part and latter part of paragraph ① is conducted in violation of approved matters, or serious safety and ethical questions are raised with respect to such clinical demonstration, etc., the Minister of Food and Drug Safety may order that necessary steps shall be taken to halt conducing the clinical demonstration, etc., stop using medicinal

- 24 -

products, etc. for the clinical demonstration, etc., or recall or dispose of such medicinal products, etc. <Amended by Act No. 11690, Mar. 23, 2013>

⑦ Matters concerning approval of plans for clinical demonstrations, etc. under paragraph ①, matters to be included in the plans, the details of the consent of a testee of a clinical demonstration, etc. and the timing and methods thereof under paragraph 3 ③, standards for a clinical demonstration, etc., and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 34-2 (Designation, etc. of Clinical Demonstration Institution, etc.)

① The Minister of Food and Drug Safety shall designate an institution which shall conduct clinical demonstrations referred to in Article 34 (limited to medical institutions designated under the Medical Service Act) and an institution which shall conduct biological equivalence tests referred to in Article 34 (hereinafter referred to as "biological equivalence test institution"). <Amended by Act No. 11690, Mar. 23, 2013>

② A person who desires to be designated as a clinical demonstration institution or biological equivalence test institution pursuant to paragraph ① shall have facilities, professional personnel, and equipment necessary for such clinical demonstrations.

③ Where a clinical demonstration institution or biological equivalence test institution designated pursuant to paragraph ① has conducted a clinical demonstration, etc., it shall observe the matters prescribed by Ordinance of the Prime Minister, such as preparing and issuing clinical demonstration results or biological equivalence test results and keeping records on such clinical demonstrations, etc. <Amended by Act No. 11690, Mar. 23, 2013>

④ Matters necessary for the designation requirements, procedures, methods, operation, and management of clinical demonstration institutions or biological equivalence test institutions and other matters, other than those prescribed in paragraphs ① through ③, shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23,

2013> [This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 34-3 (Designation, etc. of Non-Clinical Demonstration Institution)

① The Minister of Food and Drug Safety shall designate an institution which shall conduct non-clinical demonstrations determined and publicly notified by the Minister of Food and Drug Safety on things other than persons with regard to the safety and effectiveness of medicinal products, etc. (hereinafter referred to as "non-clinical demonstration institution"). <Amended by Act No. 11690, Mar. 23, 2013>

② A person who desires to be designated as a non-clinical demonstration institution pursuant to paragraph ① shall have facilities, professional personnel, and equipment necessary for non-clinical demonstrations referred to in paragraph ①.

③ When a non-clinical demonstration institution has conducted a non-clinical demonstration referred to in paragraph ①, it shall observe the matters prescribed by Ordinance of the

- 25 -

Prime Minister, such as preparing and issuing non-clinical demonstration results and keeping records on such non-clinical demonstration, etc. <Amended by Act No. 11690, Mar.

23, 2013>

④ Matters necessary for the designation requirements, procedures, methods, operation, and management of non-clinical demonstration institutions and other matters, other than those prescribed in paragraphs ① through ③, shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 35 (Conditional licensing)

① In granting approval under Article 31 ① and ②, the Minister of Food and Drug Safety may grant approval for the manufacturing business of drugs or items prescribed by Ordinance of the Prime Minister, on condition that the facilities referred to in Article 31 ① be established within a fixed period. <Amended by Act No. 8643, Oct. 17, 2007; Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② If a person who has obtained approval under paragraph ① fails to establish proper facilities without justifiable grounds within a period under paragraph ①, the Minister of Food and Drug Safety shall cancel such approval. <Amended by Act No. 11690, Mar. 23, 2013>

Article 35-2 (Preliminary Examination of product approval of Medicinal

Products, etc.)

① A person who desires to obtain product approval or apply for a product registration, etc. pursuant to Article 31 and a person who desires to conduct a clinical demonstration, etc pursuant to Article 34 may request, in advance, the Minister of Food and Drug Safety to examine the standards for preparing documents necessary for approval, registration, and permission, etc. <Amended by Act No. 11690, Mar. 23, 2013>

② Upon receiving a request under paragraph ①, the Minister of Food and Drug Safety shall confirm such request and inform the applicant of examination results in writing. <Amended

by Act No. 11690, Mar. 23, 2013>

③ In the case of approval, registration, and permission referred to in Articles 31 and 34, the Minister of Food and Drug Safety shall take into consideration the examination results referred to in paragraph ②. <Amended by Act No. 11690, Mar. 23, 2013>

④ Matters necessary for preliminary examination, such as the subjects, scope, procedures and methods of preliminary examination, under paragraph ① shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 36 (Pharmaceutical Qualified Person)

① A manufacturer of drugs or quasi-drugs (excluding a manufacturer of quasi-drugs who manufactures only articles falling under subparagraph 7 (a) of Article 2) shall assign the necessary number of pharmacists or oriental pharmacists to each production facility and

- 26 -

entrust them with supervision over manufacturing affairs, as prescribed by Ordinance of the Prime Minister: Provided, That in the biological preparation manufacturing industry, he/she may entrust a doctor or a technician with bacteriological knowledge, approved by the Minister of Food and Drug Safety, with supervision over the manufacturing affairs thereof. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② A manufacturer of quasi-drugs who manufactures only the articles falling under subparagraph 7 (a) of Article 2 shall assign a technician approved by the Minister of Food and Drug Safety to each of his/her production facilities and entrust them with supervision over manufacturing affairs: Provided, That in cases where the manufacturer himself/ herself is a technician approved by the Minister of Food and Drug Safety, and supervises manufacturing affairs at his/her production facility, he/she may choose not to assign an additional technician to such production facility. <Amended by Act No. 11690, Mar. 23, 2013>

③ Where a manufacturer of medicinal products, etc. intends to assign a person who supervises manufacturing affairs of medicinal products, etc. (hereinafter referred to as "qualified person") pursuant to paragraph ① or ②, he/she shall file a report with the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Newly Inserted by

Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

Article 37 (Duty to Supervise Manufacturing Medicinal Products, etc.)

① A qualified person shall observe matters prescribed by Ordinance of the Prime Minister with regard to guidance and supervision of employees engaging in the affairs of manufacturing medicinal products, etc., quality control, management of manufacturing facilities, and other matters concerning manufacturing supervision. <Amended by Act No. 8852,

Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② No qualified person shall engage in business, other than manufacture supervising duties for the relevant production facility.

③ No manufacturer or person who has obtained product approval of medicinal products, etc. shall interfere with the supervisory affairs of a qualified person, nor refuse, without justifiable grounds, any request from a qualified person on the matters necessary for carrying out his/her duties. <Amended by Act No. 8643, Oct. 17, 2007>

Article 37-2 (Training of Qualified Person, etc.)

① A qualified person shall receive training on securing of safety and effectiveness, manufacturing, and quality control of medicinal products, etc. on a regular basis.

② If necessary to prevent harm to public health, the Minister of Food and Drug Safety may order a qualified person to receive training referred to in paragraph ①. <Amended by Act

No. 11690, Mar. 23, 2013>

③ A qualified person (where a report on the alteration of a manufacturing supervisor was filed pursuant to subparagraph 3 of Article 40, such altered manufacturing supervisor shall be included) shall receive training referred to in paragraph ① within three months: Provided,

- 27 -

That the same shall not apply to a person who has received relevant education within two years before he/she becomes a qualified person.

④ In order to implement training referred to in paragraphs ① through ③, the Minister of Food and Drug Safety may designate and publicly notify a relevant professional organization or an institution as an training institution. <Amended by Act No. 11690, Mar. 23,

2013> ⑤ Matters necessary for training qualified persons other than matters prescribed in paragraphs

① through ④, such as the content, time, method, procedures and fees of training, and matters necessary for designating an training institution shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 37-3 (Safety Control of Drugs after Sale at Market)

① A person who has obtained product approval shall employ a doctor, a pharmacist, or a oriental pharmacist to perform affairs of safety control after sale at a market such as re-examination of new drugs, etc., re-evaluation of medicinal products, report on side effects, etc. as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11251,

Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>

② A person who performs affairs of safety control under paragraph ① (hereinafter referred to as a "person in charge of safety control") shall observe the matters prescribed by Ordinance of the Prime Minister about safety control of drugs under distribution. <Amended by Act No.

11690, Mar. 23, 2013>[This Article Newly Inserted by Act No. 8643, Oct. 17, 2007]

Article 38 (Duty of Production Management of Medicinal Products, etc. and

Reporting thereof)

① A manufacturer of medicinal products, etc. or a person who has obtained product approval of drugs shall observe matters prescribed by Ordinance of the Prime Minister with respect to the manufacture and quality control (including self-experiment) of medicinal products, etc. and other production supervision thereof. <Amended by Act No. 8852, Feb. 29, 2008; Act No.

9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

② A person who has obtained product approval of drugs or a manufacturer of quasi-drugs shall report the production performance of medicinal products, etc. to the Minister of Food and Drug Safety or the president of the Korea Pharmaceutical Information Service under Article 47-2 ①, as prescribed by Ordinance of the Prime Minister. <Amended by Act No.

8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 39 (Recall of Hazardous Medicinal Products, etc.)

① When those prescribed by Ordinance of the Prime Minister, among persons who have obtained product approval, manufacturers of quasi-drugs or importers and sellers of

- 28 -

medicinal products, etc., pharmacy founders, medical institution founders and other persons who are eligible to sell or deal with drugs pursuant to this Act or other Acts, become aware of that the medicinal products, etc. have a problem in the safety and efficacy in violation of Article 53 ①, 61 (including cases where it applies mutatis mutandis in Article 66) or 62 (including cases where it applies mutatis mutandis in Article 66), they shall promptly recall the medicinal products, etc. in distribution or take necessary measures for recall. In such cases, persons who have obtained product approval of drugs, manufacturers of quasi-drugs or importers of medicinal products, etc. shall report a plan of recall to the Minister of Food and Drug Safety in advance. <Amended by Act No. 8643, Oct. 17, 2007; Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② The Minister of Food and Drug Safety, Mayors/Do Governors or heads of Sis/Guns/Gus may grant mitigation or remission of the administrative disposition pursuant to Article 76 to persons who have obtained product approval of drugs, manufacturers of quasi-drugs or importers of medicinal products, etc., pharmacy founders and distributors of drugs who conscientiously perform the recall or measures necessary for the recall in accordance with paragraph ①, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8643,

Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

③ Matters necessary for the classification of hazard and standards for appraisal necessary for the recall of medicinal products, etc. pursuant to paragraph ①, plans for recall, procedures for recall and abandonment and follow-up steps of recalled medicinal products, etc. shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act

No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

Article 40 (Report on Discontinuance of Business)

In cases where a manufacturer of medicinal products, etc. or a person who has obtained approval of medicinal products, etc. falls under any of the following subparagraphs, he/she shall report such fact to the Minister of Food and Drug Safety within twenty days: Provided, That the same shall not apply to a case where a period for suspension of business is under one month: <Amended by Act No. 11690, Mar. 23, 2013>

1. In cases where a factory or an office of a contract manufacturing and sales business is closed down or shut down;

2. In cases where a factory or an office of a contract manufacturing and sales business shut down has been reopened; and

3. In cases where a manufacturing supervisor, a person in charge of safety control and other matters prescribed by Ordinance of the Ministry for Health, Welfare and Family Affairs have been changed.

[This Article Wholly Amended by Act No. 8643, Oct. 17, 2007]

Article 41 (Preparing Pharmacy Medication)

① When a pharmacy founder intends to prepare pharmacy medications, or a dispensary of a

- 29 -

medical institution designated by the Minister of Health and Welfare intends to make medications, they shall report the articles to make to the head of a Si/Gun/Gu, as prescribed by Ordinance of the Prime Minister after consultation with the Minister of Health and Welfare: Provided, That where a dispensary of a medical institution which has been established by approval from a Mayor/Do Governor pursuant to the Medical Service Act intends to make medications, they shall report to the relevant Mayor/Do Governor. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② The scope of pharmacy medication and dispensary medication, facilities of dispensaries and other necessary matters shall be prescribed by Ordinance of the Prime Minister after consultation with the Minister of Health and Welfare. <Amended by Act No. 852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

SECTION 2 Approval, etc. for Importation of Medicinal Product, etc.

Article 42 (Approval, etc. for Importation of Medicinal Products, etc.)

① Any person who intends to import medicinal products, etc. (hereinafter referred to as "importer") shall obtain approval or file a report with the Minister of Food and Drug Safety for every medicinal product, as prescribed by Ordinance of the Prime Minister. The same shall also apply in cases where he/she intends to modify the approved or registered matters. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690,

Mar. 23, 2013>

② Notwithstanding paragraph ①, the Minister of National Defense or an importer may import a relevant medicinal products, etc. without obtaining approval or applying a registration on such item under paragraph ① in any of the following cases: <Amended by Act No. 10512,

Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>

1. Cases where the Minister of National Defense desires to import medicinal products, etc., which are not produced in Korea for any urgent military purpose with prior consultation with the Minister of Food and Drug Safety on the items and quantity thereof;

2. Cases where an importer desires to import active pharmaceutical ingredients or medicinal products, etc. prescribed by Ordinance of the Prime Minister, including medicinal products, etc. for clinical demonstration, in order to manufacture medicinal products, etc.

③ An importer shall have necessary facilities in conformity with the standards of installation prescribed by Presidential Decree.

④ Articles 31 ⑦, ⑩ and ⑪, 31-2 through 31-5, 32, 33, 35-2, 36, 37, 37-2, 37-3, 38, and 75 shall apply mutatis mutandis to medicinal products, etc. that are imported pursuant to paragraph ① or to an importer thereof. In such cases, "manufacture" or "production" shall be construed as "importation", and "manufacturers or persons who have obtained product approval" shall be construed as "importers" <Amended by Act No. 8643, Oct. 17, 2007; Act No.

10512, Mar. 30, 2011; Act No. 10788, Jun. 7, 2011; Act No. 11118, Dec. 2, 2011; Act No. 11421, May. 14, 2012>

- 30 -

⑤ Matters necessary for the subjects, standards, conditions, and control, etc. of approval or registration on the import items of medicinal products, etc. referred to in paragraph ① shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008;

Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011; Act No. 11118, Dec. 2, 2011; Act No. 11690, Mar. 23, 2013>

Article 43 (International Trade, etc. in Endangered Species of Wild Fauna and

Flora)

① Any person who desires to export, import, or carry into Korea by sea, medicinal products made from processed goods of animals and plants as prescribed by the Convention on International Trade in Endangered Species of Wild Fauna and Flora, shall obtain approval from the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690,

Mar. 23, 2013>

② No person shall commit any of the following acts with respect to the horns of rhinoceroses or the bones of tigers, which are processed goods using endangered species of wild animals:1. Importing or selling the horns of rhinoceros or the bones of tigers, or storing or

displaying them for sale;2. Manufacturing or preparing medicinal products made from the horns of rhinoceros or

bones of tigers;3. Selling any medicinal products manufactured or prepared using the horns of rhinoceros or

the bones of tigers, or storing or displaying them for sale.

SECTION 3 Distribution Business of Medicinal Products, etc.

Article 44 (Distribution of Medicinal Products)

① No person other than pharmacy founders (including pharmacists or oriental pharmacists working for such medicinal products; hereafter the same shall apply in Articles 47, 48 and 50) shall sell medicinal products, etc., or acquire medicinal products, etc. for the purpose of selling: Provided, That the same shall not apply in cases where a person who has obtained product approval of medicinal products or an importer of medicinal products sells medicinal products manufactured or imported to a person who can manufacture or sell medicinal products according to this Act. <Amended by Act No. 8643, Oct. 17, 2007>

② Notwithstanding the provisions of paragraph ①, those falling under any of the following subparagraphs shall be eligible to sell medicinal products or acquire medicinal products for sales purpose: <Amended by Act No. 11421, May, 14. 2012>

1. Korea Orphan Drug Center established pursuant to Article 91;1-2. OTC drug seller registered pursuant to Article 44-2 (limited only to cases where he/she

sells OTC drugs pursuant to Article 44-2 ①); or

- 31 -

2. herb druggist or drug wholesaler permitted pursuant to Article 45.

Article 44-2 (Registration of OTC Drug Seller)

① A person who intends to sell OTC drugs (of which non-prescription drugs that can be readily used mainly for alleviation of mild symptoms with patient’s own judgment and that are prescribed and announced by the Minister of Health and Welfare within the range of 20 products while considering composition, side effect, content, dosage form, awareness, convenience of purchase, etc.; hereinafter the same shall apply) at a place, other than his/her pharmacy shall register thereon to the head of a Si/Gun/Gu as a OTC drug seller.

② A person who intends to be registered as an OTC drug seller pursuant to paragraph ① shall have a store that is open 24 hours a day all year around and satisfy the standards of registration determined by Ordinance of the Ministry of Health and Welfare while considering convenience of being used by community residents, easiness of recall of hazardous medicinal products, etc.

③ A OTC drug seller, who intends to alter the registered matters prescribed by Ordinance of the Ministry of Health and Welfare from among the matters registered, shall make alteration registration to the head of a Si/Gun/Gu.

④ In cases where a sales business of OTC drugs is closed down or shut down or where such business shut down has been reopened, he/she shall report to the head of a Si/Gun/Gu: Provided, That the same shall not apply to a case where a period for suspension of business is under one month.

⑤ Matters necessary for registration, alteration registration, etc. pursuant to paragraphs ① through ③ and for the methods and procedures for discontinuance, suspension and reopen pursuant to paragraph ④ shall be prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Newly Inserted by Act No. 11421, May. 14, 2012]

Article 44-3 (Education for OTC Drug Seller)

① A person who intends to register as an OTC drug seller pursuant to Article 44-2 ① shall receive education on quality control and safety of OTC drugs in advance.

② If necessary to prevent harm to public health, the Minister of Health and Welfare may order an OTC drug seller (including his/her employees) to receive education on quality control and safety of OTC drugs.

③ In order to implement education referred to in paragraphs ① and ②, the Minister of Health and Welfare may designate a relevant organization or an institution as an education institution.

④ Matters necessary for details, time, method, procedures and fees of education under paragraphs ① and ② and for designation, operation, and cancellation of an education institution under paragraph ③ shall be prescribed by Ordinance of the Ministry of Health and Welfare.

- 32 -

[This Article Newly Inserted by Act No. 11421, May. 14, 2012]

Article 44-4 (Matters to be observed by OTC Drug Seller)

An OTC drug seller shall observe the following subparagraphs:1. He/She shall manage his/her facility and OTC drugs in a manner not inflicting harm to

health and sanitation and to keep the efficacy of medicinal products therein from falling;2. He/she shall thoroughly oversee his/her employees in order to prevent any sanitary

incident;3. He/she shall observe matters prescribed by Ordinance of the Ministry of Health and

Welfare regarding safe control such as an age restriction and quantity level limits at one time when selling OTC drugs;

4. He/She shall observe other matters corresponding to the provisions of subparagraphs 1 through 3 as prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Newly Inserted by Act No. 11421, May. 14, 2012]

Article 44-5 (Application)

① Article 39 ①, Article 47 ①, Article 50 ① and ③, Article 56 ②, Article 68-7, Article 69, Article 71 and Article 72-2 shall apply mutatis mutandis to OTC drug sellers registered under Article 44-2 ①. In this case, "a pharmacy founder" shall be construed as "an OCT drug seller registered under Article 44-2 ①" and "non-prescription drugs" under Article 50 ③ shall be construed as "OTC drugs under Article 44-2 ①".

② Article 47-2 ② shall apply to an OTC drug seller registered under Article 44-2 ①. In such cases, "pharmacy" shall be construed as "OTC drug seller".

[This Article Newly Inserted by Act No. 11421, May. 14, 2012]

Article 45 (Licenses of Medicinal Products Distribution Business)

① A person who intends to become a herb druggist or drug wholesaler pursuant to Article 44 ② 2 shall be licensed by the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall apply to the modification of the licensed matters. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788,

Jun. 7, 2011>

② A herb druggist or a medicinal product wholesaler who desires to obtain approval pursuant to paragraph ① shall have the facilities as prescribed in the following subparagraphs:

<Amended by Act No. 10512, Mar. 30, 2011>

1. With regard to a herb druggist, a place of business and other facilities meeting the standards for facilities prescribed by Presidential Decree;

2. With regard to a medicinal product wholesaler, a place of business, a warehouse, and other facilities meeting the standards for facilities prescribed by Presidential Decree. In such cases, the size of the warehouse shall be at least 264 square meters: Provided, That in cases where only imported medicinal products, reagents, or medicinal product substances are

- 33 -

handled, the size of the warehouse shall be at least 66 square meters, while in cases where only herb drugs, medicinal gases for medical purposes, and radiopharmaceuticals are handled, the standards for the warehouse sizes shall not be applied.

③ A license of herb druggist pursuant to paragraph ① shall be granted to a person who has passed a herb druggist examination prescribed by Presidential Decree by limiting districts prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852,

Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

④ A herb druggist who has obtained a license pursuant to paragraph ① may sell herb drugs after mixing them in accordance with a prescription recorded in an established herb book or with a prescription of a herb doctor.

⑤ A medicinal product wholesaler who has obtained a license pursuant to paragraph ① shall employ a pharmacist and have him/her administer duties, and a herb wholesaler shall employ any of the following persons and have him/her administer duties: Provided, That in cases where the medicinal product wholesaler who himself/herself is a pharmacist administers duties in person, or the herb wholesaler who falls under any of the following subparagraphs administers duties in person, this shall not apply: <Amended by Act No. 8852,

Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

1. A pharmacist;2. A oriental pharmacist;3. A herb druggist;4. A person who has completed a herb-related course of a college or university accredited

by the Minister of Health and Welfare.⑥ Where a medicinal product wholesaler or a herb wholesaler intends to employ a person

who shall administer affairs pursuant to paragraph ⑤, he/she shall file a report with the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare. <Newly Inserted by Act No. 10788, Jun. 7, 2011>

⑦ Matters necessary for the standards, conditions and management of approval pursuant to paragraph ① shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011>

Article 46 (Reasons for Disqualification for approval for herb druggist or

Medicinal Product Wholesaler)

A person who falls under any of the following subparagraphs shall not be permitted for the license of herb druggist or medicinal product wholesaler: <Amended by Act No. 10788, Jun. 7, 2011>

1. Person falling under any of subparagraphs of Article 5;2. Person for whom one year has not passed after approval was revoked pursuant to Article

76;3. Founder of a medical institution (where the medical institution is a juristic person, the

officers and staff thereof) or a pharmacy founder;

- 34 -

4. Person who was declared bankrupt but has not yet been reinstated.

Article 47 (Order in Distribution of Medicinal Products, etc.)

① A pharmacy founder, a person who has obtained product approval of medicinal products, an importer and a distributor of medicinal products and other persons who are entitled to sell medicinal products pursuant to this Act shall abide by the matters necessary to establish a distribution system of medicinal products, etc. and to maintain distribution order, as prescribed by Presidential Decree. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb.

29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② No person who has obtained product approval of medicinal products, importer and wholesaler of medicinal products shall offer any money, articles, labor, entertainment or other economic interest (hereinafter referred to as "economic interest , etc.") to a pharmacist, oriental pharmacist (including persons working for the relevant pharmacy; hereafter the same shall apply in this Article), medical personnel, medical institution founders (including the representative, director and other employees of a juristic person) or persons working for the relevant medical institution for the purpose of sales promotion, such as adoption of medicinal products or inducement of prescription: Provided, That the same shall not apply to the economic interest, etc. within the scope determined by Ordinance of the Ministry of Health and Wealth after consultation with the Minister of Food and Drug Safety, such as provision of samples, support of symposiums, support for clinical demonstrations, product presentation, discount of expenses pursuant to price payment conditions, and post-marketing survey (hereinafter referred to as "provision, etc. of samples"). <Newly Inserted by Act No. 10324, May 27, 2010; Act No. 11690, Mar. 23, 2013>

③ No pharmacist and oriental pharmacist shall receive any economic interest, etc. from a person who has obtained product approval of medicinal products, an importer and a wholesaler of medicinal products for the purpose of sales promotion, such as adoption of medicinal products: Provided That the same shall not apply to the economic interest, etc. within the scope determined by Ordinance of the Ministry of Health and Welfare after consultation with the Minister of Food and Drug Safety, such as provision, etc. of samples. <Newly Inserted by Act No. 10324, May 27, 2010; Act No. 11690, Mar. 23, 2013>

④ No medicinal product wholesaler shall sell medicinal products, directly or through another medicinal product wholesaler, to a medical institution or a pharmacy falling under any of the following subparagraphs with which he/she has special relationship: Provided, That the same shall not apply to herb drugs: 1. Where a person who has special relationship falling under any of the following items

with a medicinal product wholesaler (hereinafter referred to as "specially related person") is a founder of a medical institution or a pharmacy founder, the relevant medical institution or pharmacy;

(a) If a medicinal product wholesaler is an individual, his/her relatives within the second degree of relationship (referring to the definition of relatives under Article 767 of the Civil Act; hereinafter the same shall apply);

- 35 -

(b) If a medicinal product wholesaler is a juristic person, executives of the relevant juristic person and their relatives within the second degree of relationship;

(c) If a medicinal product wholesaler is a juristic person, a person who actually controls the relevant juristic person (referring to a person who has contributed or owns the share exceeding 50/100 of the total amount of contributions, the total issued stocks, or the total contributed shares of the relevant juristic person, and a person who wields a dominant influence over the organization of executives or business operation, etc.; hereinafter the same shall apply);

(d) If a specially related person in item (c) is a juristic person, executives of the relevant juristic person or a person who actually controls the relevant juristic person;

(e) If a specially related person in items (c) and (d) is an individual, his/her relatives within the second degree of relationship;

(f) A juristic person which actually controls medicinal product wholesalers;(g) A juristic person actually controlled by a specially related person in this

subparagraph;(h) An employee of a medicinal product wholesaler or of a specially related person in

this subparagraph (referring to executives in the case of a juristic person, and commercial employees and employees by an employment contract in the case of individuals; hereinafter the same shall apply in this Article);

2. Where a specially related person falling under any of the following items with a founder of a medical institution or a pharmacy founder is a medicinal product wholesaler, the relevant medical institution or pharmacy;

(a) If a founder of a medical institution or a pharmacy founder is an individual, his/her relatives within the second degree of relationship;

(b) If a founder of a medical institution is a juristic person, executives of the relevant juristic person and their relatives within the second degree of relationship;

(c) If a founder of a medical institution is a juristic person, a person who actually controls the relevant juristic person;

(d) If a specially related person in item (c) is a juristic person, executives of the relevant juristic person and a person who actually controls the relevant juristic person;

(e) If a specially related person in items (c) and (d) is an individual, his/her relatives within the second degree of relationship;

(f) A juristic person actually controling a medical institution which is a juristic person; (g) A juristic person actually controlled by a specially related person in this

subparagraph;(h) Employees of a founder of a medical institution, a pharmacy founder, or a specially

related person in this subparagraph. <Newly Inserted by Act No. 10788, Jun. 7, 2011>

Article 47-2 (Designation and Operation of Korea Pharmaceutical Information

- 36 -

Service)

① The Minister of Health and Welfare may designate a specialized agency or organization as an agency for information control of distribution of medicinal products (hereinafter referred to as the "Korea Pharmaceutical Information Service"), as prescribed by Presidential Decree, for collection, investigation, processing, utilization and provision of information on distribution of medicinal products, such as manufacture, importation, supply and details of use of medicinal products and have it perform such affairs. <Amended by Act No. 8852, Feb.

29, 2008; Act No. 9932, Jan. 18, 2010>

② In cases where a person who has obtained product approval of medicinal products, an importer and a wholesaler of medicinal products has supplied medical institutions, pharmacies and wholesalers of medicinal products with medicinal products, he/she shall submit details of such supply to the Korea Pharmaceutical Information Service, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That the same may be omitted when he/she has supplied medicinal products in a manner that details of supply can be confirmed, as prescribed by Ordinance of the Ministry of Health and Welfare.

③ The Korea Pharmaceutical Information Service may request the State, local governments and other public organizations to provide it with necessary data for efficient control of the information on distribution of medicinal products, and the State, local governments and other public organizations which have been requested to provide such data shall comply with such request unless extenuating circumstances exist. In such cases, such data provided to the Korea Pharmaceutical Information Service shall be utilized free of royalties, fees, etc.

④ The Minister of Health and Welfare and the Minister of Food and Drug Safety may order the president of the Korea Pharmaceutical Information Service to report the current status of management and distribution of medicinal products. <Amended by Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

⑤ The Minister of Health and Welfare may fully or partially subsidize expenses incurred in operation of the Korea Pharmaceutical information Service. <Amended by Act No. 8852, Feb.

29, 2008; Act No. 9932, Jan. 18, 2010>

⑥ Matters necessary for operation, etc. of the Korea Pharmaceutical Information Service shall be prescribed by Presidential Decree.

[This Article Newly Inserted by Act No. 8643, Oct. 17, 2007]

Article 48 (Prohibition of Sale of Unsealed Medicinal Products)

No person shall sell medicinal products, etc. after breaking the seal of container or package sealed by manufacturers, persons who have obtained product approval of medicinal products, etc. or importers pursuant to Article 63: Provided, That the same shall not apply in any of the following cases: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No.

9932, Jan. 18, 2010>

1. Where a pharmacy founder prepares and sells medicinal products according to

- 37 -

prescriptions made by a doctor, dentist or herb doctor, or pursuant to the provisos to Article 23 ③ and ⑥ or to Article 4 of the Addenda of the Pharmaceutical Affairs Act amended by Act No. 4731;

2. Where a pharmacy founder sells prepared herbal medicinal product after opening them;3. Where a person designated by the Minister of Health and Welfare opens and sells

medicinal products within the scope prescribed by Ordinance of the Ministry of Health and Welfare.

Article 49 (Restrictions on Articles for Sale by Medicinal Product Sellers)

No medicinal product seller shall sell medicinal products, other than those designated separately by the Minister of Health and Welfare, nor store or display them for sale. <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 50 (Distribution of Medicinal Products)

① No pharmacy founder or medicinal product distributor shall sell medicinal products at a place, other than his/her pharmacy or shop: Provided, That the same shall not apply in cases where approval therefor is obtained from the head of a Si/Gun/Gu.

② No pharmacy founder shall sell any prescription drugs except for cases of preparing them in accordance with a prescription issued by a doctor or dentist: Provided, That the same shall not apply in cases where such medicinal products are sold to any person who has established a veterinary hospital in accordance with the Veterinarians Act, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008;

Act No. 9932, Jan. 18, 2010>

③ Any pharmacy founder may sell any non-prescription drugs without prescriptions issued by a doctor or a dentist.

④ Where any pharmacy founder deems it necessary to sell non-prescription drugs, he/she may offer guidance on taking such medicinal products.

CHAPTER VI HANDLING OF MEDICINAL PRODUCTS, ETC.

SECTION 1 Criteria and Approval

Article 51 (Pharmacopoeia of Republic of Korea)

① In order to insure the appropriateness in the nature, state, quality and storing method of medicinal products, etc., the Minister of Food and Drug Safety shall enact the Pharmacopoeia of the Republic of Korea through the deliberation of the Central Pharmaceutical Affairs Council, and shall announce it publicly. <Amended by Act No. 10788,

Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

② The Pharmacopoeia of the Republic of Korea shall be divided into Parts I and II: medicinal

- 38 -

product substances that are frequently used and the basic preparation of drugs shall be mainly listed in Part I, and the mixed preparations of medicinal products and the medicinal products, etc. not listed in Part I shall be mainly listed in Part II. <Amended by Act No.

10788, Jun. 7, 2011>

Article 52 (Criteria for Medicinal Products, etc.)

① With regard to biological preparations and medicinal products which are not listed in the Pharmacopoeia of the Republic of Korea, the Minister of Food and Drug Safety may determine the nature, state, quality and storing methods and other necessary criteria thereof, after consultation with the Central Pharmaceutical Affairs Council. <Amended by Act No.

10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

② When the Minister of Food and Drug Safety deems it necessary for the prevention of any danger or harm to the public health and sanitation, he/she may, after consultation with the Central Pharmaceutical Affairs Council, determine the manufacturing method, nature, efficacy, quality and storing method of quasi-drugs and other necessary criteria thereof. <Amended by Act No. 11690, Mar. 23, 2013>

Article 53 (Medicinal Products under National Batch Release)

① A person who desires to sell or to display, keep, or store, for sale, the medicinal products prescribed by Ordinance of the Primem Minister, among those falling under any of the following subparagraphs, shall obtain shipment approval from the Minister of Food and Drug Safety after the data on manufacturing and quality control of the medicinal products are examined and authorized: <Amended by Act No. 11690, Mar. 23, 2013>

1. Biological products;2. Medicinal products liable to be changed or spoiled in quality;3. Other preparation of drugs deemed necessary by the Minister of Food and Drug Safety.

② Matters concerning the procedures and methods for shipment approval referred to in paragraph ① and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 54 (Radiopharmaceuticals)

The Minister of Food and Drug Safety may determine the necessary matters concerning manufacture and imports of radiopharmaceuticals after consultation with the Minister of Science, ICT and Future Planning. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

Article 55 (Toxic and Habit-forming Medicinal Products)

The necessary matters concerning the manufacturing and management of medicinal products that might affect the human body and thus cause toxicosis or habituation, shall be determined by a

- 39 -

separate Act.

SECTION 2 Handling of Medicinal Products

Article 56 (Matters to be Stated on Containers, etc. of Medicinal Products)

① A person who has obtained product approval and an importer of medicinal products shall enter the following subparagraphs on the containers or packages of medicinal products: Provided, That in the case of the containers or packages prescribed by Ordinance of the Prime Minister, some of the following subparagraphs may not be entered or only some of the following subparagraphs may be entered: <Amended by Act No. 11421, May. 14, 2012;Act

No. 11690, Mar. 23, 2013> 1. Trade name and address of a person who has obtained product approval of medicinal

products or an importer of medicinal products (in the case of manufacture by entrustment, trade name and address of a factory shall be included);

2. Name (as for medicinal products listed in the Pharmacopoeia of the Republic of Korea, the names provided for in such Pharmacopoeia, and as for other medicinal products, general names);

3. Manufacturing number and effective period or time-limit for use;4. Weight, capacity, or number of articles;5. Matters to be entered in containers or packages as prescribed by the Pharmacopoeia of

the Republic of Korea;6. As for the medicinal products, the standards for which are determined under Article 52

①, the methods of storing such medicinal products and other matters to be stated on the containers or packages in accordance with such standards;

7. As for the medicinal products not listed in the Pharmacopoeia of the Republic of Korea, names of effective ingredients (if there are general names, such names shall be stated) and quantity (if effective ingredients are not clear, the essence thereof and outline of manufacturing methods shall be stated);

8. The letter "prescription drug" or "non-prescription drugs" [OTC drugs is "over-the-counter drug"]; <Amended by Act. No 11421, May. 14, 2012>

9. Matters provided for in subparagraphs 1 through 3 of Article 58;10. Other matters prescribed by Ordinance of the Prime Minister.

② A person who sells medicinal products directly to consumers, such as a pharmacy founder, shall state prices of medicinal products on the containers or packages of medicinal products, as prescribed by the Minister of Health and Welfare.

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 57 (Matters to be Stated on Outside Packages)

If the matters listed in subparagraphs of Article 56 ① and 56 ②, which have been stated on the immediate container or package of medicinal products, are not visible because they are

- 40 -

obstructed by the outside container or wrapper, such matters shall also be stated on the outside container or wrapper. <Amended by Act No. 10788, Jun. 7, 2011>

Article 58 (Matters to be Stated on Appended Notes)

The following matters shall be stated in notes appended to medicinal products: <Amended by Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

1. Directions, doses, and other precautions necessary for use or handling;2. As for the medicinal products listed in the Korean Pharmacopoeia, matters to be stated

on notes appended to the medicinal products, containers, or packages thereof provided for in the Pharmacopoeia of the Republic of Korea;

3. As for the medicinal products, the standards for which are determined under Article 52 ①, matters to be stated on notes appended to the medicinal products, containers, or packages thereof in accordance with such standards;

4. Other matters prescribed by Ordinance of the Prime Minister.

Article 59 (Precautions in Statement)

Matters provided for in Articles 56 though 58 shall be stated on places which are more easily seen than other letters, news articles, pictures or designs, and such matters shall be stated precisely in easy and understandable terms, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 60 (Matters Prohibited to State)

Contents falling under the following subparagraphs shall not be stated on the notes appended to medicinal products, or containers or packages of medicinal products: <Amended by Act No. 8643,

Oct. 17, 2007>

1. False matters or those apprehended to be misunderstood with regard to the medicinal product concerned;

2. Efficacy or effect which has not been approved or registered pursuant to Article 31 ② and ③ or 41 ①; and

3. Direction, dosage or period of use which is dangerous to public health and sanitation,

Article 61 (Prohibition of Distribution, etc.)

① No one shall sell, or store or display for sales purpose the medicinal products in the following subparagraphs: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7,

2011>

1. Medicinal products in violation of the provisions of Articles 56 through 60 or counterfeit medicinal products; and

2. Medicinal products manufactured or imported in violation of Articles 31 ② and ③, 41

- 41 -

①, 42 ① and ③, and 43 ①.② No one shall put a mark on the container, package or appended note, which is apprehended

to make an article other than medicinal product misunderstood as having efficacy, effect, etc., or shall put an advertisement of these contents, sell an article indicated or advertised like medicinal products, store or display them for sales purpose.

Article 62 (Prohibition of Manufacturing, etc.)

No one shall sell medicinal products falling under any of the following subparagraphs nor manufacture, import, store, display them for sales purposes: <Amended by Act No. 8643, Oct. 17,

2007; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

1. Medicinal products which are listed in the Pharmacopoeia of the Republic of Korea, but whose nature, efficacy or quality does not meet the standards specified in the Pharmacopoeia of the Republic of Korea;

2. Medicinal products which are approved or registered under Articles 31 ② and ③ and 41 ①, but whose ingredients or quantities (if effective ingredients are not clear, the essence thereof or outline of manufacturing methods) are different from contents as approved or registered;

3. Medicinal products whose standards are determined under Article 52 ①, but which do not meet such standards;

4. Medicinal products all or part of which are made from unclean, or degenerated or spoiled materials;

5. Medicinal products which are tainted or deemed to have been tainted by germs that may cause a disease;

6. Medicinal products to which alien substances are mixed or adhered;7. Medicinal products in which tar pigment other than that determined by the Minister of

Food and Drug Safety is used;8. Medicinal products which are manufactured under unsanitary conditions that might do

harm to public health and sanitation, or which are manufactured at a place where the manufacturing equipment becomes unconformed to such standards as prescribed by Presidential Decree;

9. Medicinal products which are deemed to cause harm to the public health and sanitation, because of unsanitary containers or packages;

10. Medicinal products whose containers or packages might make users misunderstand the method of using them; or

11. Medicinal products falling under Article 76 ① 4.

Article 63 (Sealing)

If a manufacturer, a person who has obtained product approval, or an importer of medicinal products sells medicinal products manufactured or imported by himself/herself, he/she shall seal the containers or packages of such medicinal products, as prescribed by Ordinance of the Prime

- 42 -

Minister: Provided, That this shall not apply in cases where he/she sells them to a manufacturer or a person who has obtained product approval of medicinal products. <Amended

by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 64 (Safety Containers or Packages, etc.)

① Where a person who has obtained product approval of medicinal products or an importer of medicinal products sell medicinal products manufactured or imported by him/herself, he/she shall use safety containers or packages in order to prevent the accidents of medicinal products by children due to misuses: Provided, That the same shall not apply in cases where they are sold to manufacturers or persons who have obtained product approval of medicinal products. <Amended by Act No. 8643, Oct. 17, 2007>

② Articles which shall use safety containers or packages and criteria, etc. for safety containers or packages shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No.

8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

SECTION 3 Quasi-drugs

Article 65 (Matters to be Stated on Containers, etc. of Quasi-drugs)

① A manufacturer and an importer of quasi-drugs shall state the following matters on the containers, packages, or appended notes (only in cases where appended notes exist) of quasi-drugs: Provided, That in the case of the containers or packages designated by Ordinance of the Prime Minister, only the names of quasi-drugs and the firm name of a manufacturer or an importer may be stated: <Amended by Act No. 11690, Mar. 23, 2013>

1. Names of quasi-drugs (excluding articles under subparagraph 7 (a) of Article 2);2. Firm name and address of a manufacturer or importer;3. Capacity or weight (or number, in cases of articles under subparagraph 7 (a) of Article

2);4. Manufacturing number and date (referring to the period of use, instead of the

manufacturing number and date, in cases of articles under subparagraph 7 (b) of Article 2);

5. Names of major ingredients (excluding articles under subparagraph 7 (a) of Article 2);6. For products, the standards for which are determined under Article 52 ②, the methods

of storing them, and other matters to be stated on the container or package under such standards;

7. The letter "quasi-drug";8. Other matters prescribed by Ordinance of the Prime Minister.

② A person who sells quasi-drugs directly to consumers, such as a pharmacy founder, shall state prices of quasi-drugs on the containers or packages of quasi-drugs, as prescribed by the Minister of Health and Welfare.

- 43 -

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 65-2 (Caution when Matters are Stated)

The matters to be stated under Article 65 shall be entered in an area which stands out more conspicuously than other letters, article, picture or design, and such matters shall be written clearly in words easy to read and understand, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013> [This Article Newly Inserted by Act No. 11251, Feb. 1, 2012]

Article 66 (Application Mutatis Mutandis)

Articles 60 through 63 (Articles 60 through 62 in case of goods falling under subparagraph 7 (a) of Article 2 from among the quasi-drugs) shall apply mutatis mutandis to quasi-drugs. In this case, "medicinal products" shall be deemed "quasi-drugs" and Article 31 ② and ③ shall be construed as Article 31 ④. <Amended by Act No. 11251, Feb. 1, 2012>

SECTION 4 Pharmaceutical Organizations

Article 67 (Organization)

Manufacturers, persons who have obtained product approval, importers of medicinal products, etc. or distributors of medicinal products may form an incorporated association respectively in order to secure independent activities and common interests and to contribute to the improvement of the national public health. <Amended by Act No. 8643, Oct. 17, 2007>

SECTION 5 Advertisement of Medicinal Products, etc.

Article 68 (Prohibition of Exaggerated Advertisement, etc.)

① Names, manufacturing methods, efficacy, or performance of medicinal products, etc. shall not be advertised falsely or exaggeratedly.

② No article shall be used to make people misunderstand that doctors, dentists, herb doctors, veterinarians or other persons guarantee the efficacy or performance of medicinal products, etc.

③ No efficacy or performance of medicinal products, etc. shall be advertised by suggestive articles, photographs, designs and other suggestive methods.

④ No documents or designs which suggest induced abortion shall be used with respect to medicinal products.

⑤ Names, manufacturing methods, efficacy or performance of medicinal products, etc. shall not be advertised without obtaining approval or registration, as prescribed by Article 31 ② and ③ or 42 ①. <Amended by Act No. 8643, Oct. 17, 2007>

⑥ Necessary matters for the scope and other matters of advertisement of medicinal products,

- 44 -

etc. shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb.

29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>>

Article 68-2 (Deliberation of Advertisement)

① In cases where a manufacturer, a person who has obtained product approval or an importer of medicinal products intends to advertise such medicinal products manufactured or imported, he/she shall undergo deliberation by the Minister of Food and Drug Safety as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

② The Minister of Food and Drug Safety may entrust a juristic person incorporated pursuant to Article 67 with affairs concerning deliberation of advertisement of medicinal products. <Amended by Act No. 11690, Mar. 23, 2013>

③ Procedure for and method of deliberation of advertisement under paragraph ① and matters necessary for raising an objection against the results of deliberation, altering the details of deliberation, and indicting the results of deliberation shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 8643, Oct. 17, 2007]

SECTION 5 Korea Institute of Drug Safety and Risk Management

Article 68-3 (Establishment)

① The Korea Institute of Drug Safety and Risk Management (hereinafter referred to as the '"Korea Institute of Drug Safety and Risk Management") shall be established to efficiently and systematically perform the affairs of collecting, managing, analyzing, evaluating, and supplying a variety of information on medicinal product safety, such as side effects caused by medicinal products, etc., information on product approval, and information on product registration (hereinafter referred to as "drug safety information").

② The Korea Institute of Drug Safety and Risk Management shall be a juristic person.③ The provisions concerning incorporated foundations under the Civil Act shall apply mutatis

mutandis to the Korea Institute of Drug Safety and Risk Management, except as prescribed by this Act.

④ Other matters necessary for the organization and operation of the Korea Institute of Drug Safety and Risk Management shall be prescribed by Presidential Decree.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-4 (Business)

The Korea Institute of Drug Safety and Risk Management shall perform any of the following business entrusted by the Minister of Food and Drug Safety pursuant to Article 84 and profitable business concerning drug safety information prescribed by Presidential Decree: <Amended by Act No. 11690, Mar. 23, 2013>

1. Business of investigating and identifying causal relationships of side effects of medicinal

- 45 -

products, such as pharmaceutical accidents; 2. Business of establishing a medicinal product safety information management system to

collect and manage medicinal product safety information; 3. Business of collecting, analyzing, assessing, managing, and supplying medicinal product

safety information; 4. Investigation, research, education, and publicity aimed at developing and utilizing

medicinal product safety information. [This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-5 (Financial Resources for Operation)

The Korea Institute of Drug Safety and Risk Management shall be operated by contributions by the Government and persons other than the Government and other gains.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-6 (Submission, etc. of Business Plan)

① The business year of the Korea Institute of Drug Safety and Risk Management shall conform to the fiscal year of the Government.

② The Korea Institute of Drug Safety and Risk Management shall prepare a business plan and budget bill for each fiscal year every year, as prescribed by Presidential Decree, and obtain approval from the Minister of Food and Drug Safety. The same shall apply to cases where it intends to alter such business plan and budget bill. <Amended by Act No. 11690, Mar. 23,

2013>[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-7 (Request for Provision of Data)

① If deemed necessary for collecting and assessing, etc. medicinal product safety information, the president of the Korea Institute of Drug Safety and Risk Management may require an institution or a person falling under any of the following subparagraphs to provide data on medicinal product safety information: 1. The State or a local government;2. A public institution or a public organization; 3. A research institute; 4. A pharmacy founder or a founder of a medical institution;5. A person who may handle medicinal products in accordance with this Act, such as a

manufacturer, a person who obtained product approval, an importer, or a seller of medicinal products, etc.

② An institution or a person who has received a request under paragraph ① shall comply with such request, unless any extenuating circumstances exist otherwise.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-8 (Report on Side Effects, etc.)

- 46 -

① Where a manufacturer, a person who has obtained product approval, an importer, or a medicinal product wholesaler of medicinal products, etc. happens to know a harmful case suspected of having been caused by medicinal products, etc. which relates to disease, disability, death, and the safety and effectiveness of other medicinal products, etc. prescribed by Ordinance of the Prime Minister, he/she shall file a report with the president of the Korea Institute of Drug Safety and Risk Management, as prescribed by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

② Where a pharmacy founder and a founder of a medical institution happens to know a harmful case suspected of having been caused by medicinal products, etc. which is serious disease, disability, and death prescribed by Ordinance of the Prime Minister, he/she shall file a report with the president of the Korea Institute of Drug Safety and Risk Management, as prescribed by the Minister of Food and Drug Safety. <Amended by Act No.

11690, Mar. 23, 2013>

③ The president of the Korea Institute of Drug Safety and Risk Management shall file a report on the matters reported pursuant to paragraphs ① and ② with the Minister of Food and Drug Safety, as prescribed by the Minister of Food and Drug Safety. <Amended by Act

No. 11690, Mar. 23, 2013> [This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-9 (Duty of Confidentiality)

No executive, employee, or person who was previously in a position of the Korea Institute of Drug Safety and Risk Management shall divulge a secret that he/she knew while fulfilling his/her duties.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-10 (Prohibition of Use of Similar Name)

Any person, other than the Korea Institute of Drug Safety and Risk Management, shall be prohibited from using the name, the Korea Institute of Drug Safety and Risk Management or any other similar name.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 68-11 (Establishment of Deliberative Council on Side Effects of Drugs)

① In order to deliberate on matters of judging side effects and dangerousness of medicinal products, such as pharmaceutical accidents, and identifying causes thereof, the Deliberative Council on Side Effects of Drugs (hereinafter referred to as the "Deliberative Council") shall be established in the Ministry of Food and Drug Safety. <Amended by Act No. 11690,

Mar. 23, 2013>

② The Deliberative Council shall be comprised of 10 to 15 members, including one chairperson, and the chairperson shall be elected from among its members.

③ The members shall be appointed or commissioned by the Minister of Food and Drug Safety, as prescribed by Presidential Decree, and at least one of the following persons shall

- 47 -

be included: <Amended by Act No. 11690, Mar. 23, 2013>

1. A person with expertise in public health care and medicinal products;2. A person recommended by a non-profit, non-governmental organization under Article 2

of the Assistance for Non-Profit, Non-Governmental Organizations Act; 3. An expert in the Medical Service Act and forensic medicine who is a qualified judge,

prosecutor, or a lawyer;4. A public official in the relevant central administration agency prescribed by Presidential

Decree. ④ The Deliberative Council shall deliberate on the following matters:

1. Matters on side effects and possible harm of medicinal products, etc.; 2. Matters on identifying the causal relationship of side effects of medicinal products, etc.

⑤ The Deliberative Council may establish a professional committee under its control to have the committee deliberate on the matters prescribed in the subparagraphs of paragraph ④ in a professional point of view.

⑥ Matters on the organization and operation of the Deliberative Council and the professional committee and other necessary matters shall be prescribed by Presidential Decree.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

CHAPTER VII SUPERVISION

Article 69 (Reporting, Inspection, etc.)

① The Minister of Health and Welfare, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order the following matters: <Amended by Act

No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

1. Ordering pharmacy founders, medical institution founders, manufacturers, persons who have obtained product approval, importers or distributors of medicinal products, etc., persons who obtained approval for plans for clinical demonstrations or biological equivalence tests, clinical demonstration institutions, biological equivalence test institutions, non-clinical demonstration institutions, and quality examination institutions under Article 73 ①, and other persons engaged in the business of handling medicinal products, etc. to submit necessary documents or other data;

2. Ordering the relevant public officials to enter pharmacies, medical institutions, factories, warehouses, shops or offices that manufacture, store or handle medicinal products, etc., clinical demonstration institutions, biological equivalence test institutions, non-clinical demonstration institutions, quality examination institutions under Article 73 ①, places where medicinal products, etc. are handled for clinical demonstrations or biological equivalence tests, or other places where medicinal products, etc. are handled for business, and inspect the facilities concerned, relevant books and documents or other articles, or

- 48 -

query to persons concerned;3. Collecting the minimum quantity of articles necessary for quality examination into

products, medicinal products, etc. which are suspected to fall under Article 71 ①.② Any public official who performs an inspection under paragraph ① shall carry with him/her

a certificate indicating such authority and produce it to persons concerned.③ The authority and the scope of duties of pertinent public officials and other necessary

matters under paragraph ② shall be prescribed by Ordinance of the Prime Minister after consultation with the Minister of Food and Drug Safety. <Amended by Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010>

Article 70 (Order to Commence Business, etc.)

① If it is recognized that medicinal product manufacturers, persons who have obtained product approval, pharmacy founders, or medicinal product distributors cause or are likely to cause remarkable impediment in the purchase of medicinal products through joint suspension of production and sale of medicinal products, collective business suspension, or closure, the Minister of Health and Welfare, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order them to commence production of medicinal products or duties. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29,

2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② No medicinal product manufacturer, person who has obtained product approval, pharmacy founder, or medicinal product distributor shall refuse an order referred to in paragraph ① without justifiable grounds. <Amended by Act No. 8643, Oct. 17, 2007>

Article 71 (Order, etc. of Scrapping)

① The Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order persons who have obtained product approval of medicinal products, manufacturers of quasi-drugs, importers or distributors of medicinal products, etc., pharmacy founders, medical institution founders, or other persons prescribed by Ordinance of the Prime Minister among persons eligible to sell or deal with medicinal products pursuant to this Act or other Acts to scrap the medicinal products, etc. which have been sold, stored, displayed, manufactured or imported in violation of Articles 53 ①, 61 (including cases where it applies mutatis mutandis in Article 66), and 62 (including cases where it applies mutatis mutandis in Article 66) or bad medicinal products, etc. or raw materials and materials thereof, etc. in a manner that prevents hazards to public health or to take other necessary measures. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act

No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

② When any medicinal products, etc. actually harms or is likely to harm public health, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order persons who have obtained product approval of medicinal products, manufacturers of quasi-drugs, importers or distributors of medicinal products, etc., or pharmacy founders, medical institution founders, or other persons prescribed by Ordinance of the Prime Minister

- 49 -

among persons eligible to sell or deal with medicinal products pursuant to this Act or other Acts, to recall and scrap such medicinal products, etc. under distribution or to take other necessary measures. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act

No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

③ In cases where any person who has been ordered pursuant to paragraph ① or ② fails to comply with such order, or in cases of emergency for public health, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may have the competent public officials recall and scrap the relevant medicinal product, etc., or take other necessary measures. <Amended by Act No. 11690, Mar. 23, 2013>

④ The provisions of Article 69 ② shall apply mutatis mutandis to paragraph ②.⑤ The grades of harms and standards for appraisal of medicinal products, etc., recall and

scrapping of medicinal products, etc. and matters necessary for other measures, etc. pursuant to paragraph ② shall be prescribed by Ordinance of the Prime Minister.

<Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 72 (Announcement of Recall, etc. of Medicinal Products, etc.)

① When the Minister of Food and Drug Safety receives a report on a plan for recall of medicinal products, etc. pursuant to the latter part of Article 39 ①, he/she may order persons who have obtained product approval of medicinal products, manufacturers of quasi-drugs or importers of medicinal products, etc. to announce the recall plan: Provided, That he/she shall order a public announcement if the use of relevant medicinal products, etc. causes the occurrence of harms prescribed by Ordinance of the Prime Minister, such as a serous side effect impossible to cure completely and a side effect temporarily or medically possible to cure completely. <Amended by Act No. 8643, Oct. 17, 2007; Act No.

10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>

② Where the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu has ordered to recall and scrap medicinal products, etc. under distribution, or to take other necessary measures pursuant to Article 71 ②, he/she shall order persons who have obtained product approval of medicinal products, manufacturers of quasi-drugs, importers or distributors of medicinal product, etc., pharmacy founders, medical institution founders, or other persons prescribed by Ordinance of the Ministry of Health and Welfare from among persons eligible to sell or deal with medicinal products pursuant to this Act or other Acts, to announce such fact. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852,

Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

③ A person who has received an order for public announcement under paragraphs ① and ② shall make a public announcement in accordance with the grades of harms under Article 71 ⑤ by any of the following methods: <Newly Inserted by Act No. 11251, Feb. 1, 2012>

1. Broadcasting, daily newspaper, or the mass media which is equal to or higher than such media;

2. Medical or pharmaceutical journal or a medium which is equal to or higher than such

- 50 -

journals;3. The homepage of the relevant firm or a medium which is equal to or higher than its

homepage; ④ Matters necessary for the public announcement referred to in paragraphs ① through ③ shall

be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11251, Feb. 1, 2012;

Act No. 11690, Mar. 23, 2013>

Article 73 (Order of Examination and Quality Examination Institution)

① The Minister of Food and Drug Safety or the Mayor/Do governor may order manufacturers of medicinal products, etc., importers, or persons who obtained product approval of medicinal products to have examination into medicinal products, etc., which have been manufactured, imported, obtained product approval, or filed product registration, by a quality examination institution designated by the Minister of Food and Drug Safety or the Mayor/Do governor (hereinafter referred to as "quality examination institution"). <Amended

by Act No. 11690, Mar. 23, 2013>

② The Minister of Food and Drug Safety or the Mayor/Do governor shall designate an institution equipped with facilities and experts necessary for examination referred to in paragraph ① as a quality examination institution. <Amended by Act No. 11690, Mar. 23,

2013>

③ Where the quality examination institution has conducted examination referred to in paragraph ①, it shall observe the matters prescribed by Ordinance of the Prime Minister, such as preparing and issuing the quality examination results and keeping records on such examination. <Amended by Act No. 11690, Mar. 23, 2013>

④ Matters concerning the designation requirements, procedures, and methods for the quality examination institution and other necessary matters, except as prescribed in paragraphs ① through ③, shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No.

11690, Mar. 23, 2013>[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 73-2 (Effective Period of Designation of Quality Examination

Institution)

① The effective period of designating a quality examination institution designated pursuant to Article 73 ② shall be three years from the date on which it is designated.

② The effective period referred to in paragraph ① may be extended by up to one year only once more, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690,

Mar. 23, 2013>

③ A quality examination institution the effective period of which is terminated pursuant to paragraphs ① and ② and which satisfies the designation requirements for a quality examination institution under Article 73 ④ may be designated again as such in accordance with the same Article.

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

- 51 -

Article 73-3 (Education of Examiners)

① The representative and examiners of a quality examination institution shall receive education on the methods of quality examination, etc. each year.

② Matters on an institution which provides education on the examination methods, etc. under paragraph ①, the details of education, and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 74 (Repair Order)

When the facilities has come to fall short of the facilities standards pursuant to Articles 20 ③, 31 ① and ④, 34-2 ②, 34-3 ②, 42 ③, 45 ② and 73 ② or the facilities have become old, squalid or damaged, so that there is an apprehension that the medicinal products, etc. which have been manufactured by using the facilities would fall under any of subparagraphs of Article 62 (including the case where it applies mutatis mutandis in Article 66), the Minister of Food and Drug Safety, the Mayor/ Do governor, or the head of Si/Gun/Gu may order pharmacy founders, manufacturers, persons who have obtained product approval, importers or distributors of medicinal products, etc., clinical demonstration institutions, biological equivalence test institutions, non-clinical demonstration institutions, or quality examination institutions to repair the facilities or may order not to use all or part of the facilities until the completion of repair. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar.

23, 2013>

Article 75 (Order to Change Manager, etc.)

If a manager of a manufacturing business of medicinal products, etc. or a manager of a pharmacy has committed acts in violation of this Act or orders issued pursuant to this Act, or if the manager is deemed as unsuited as the manager, the Minister of Food and Drug Safety may order the manufacturer concerned to change the manager, and as to the manager of a pharmacy, the head of a Si/Gun/Gu may order the pharmacy founder to change the manager. <Amended by Act No. 11690, Mar. 23, 2013>

Article 76 (Revoke of approval and Suspension of Business, etc.)

① If a manufacturer or a person who has obtained product approval of medicinal products, etc., a person who has registered medicinal product substance, an importer of medicinal products, etc., a person who has obtained approval for plans for clinical demonstrations or biological equivalence tests, a pharmacy founder, or a medicinal product distributor falls under any of the following subparagraphs, the Minister of Food and Drug Safety, as for a manufacturer or a person who has obtained product approval of medicinal products, etc., a person who has registered medicinal product substance or an importer of medicinal products, etc., a person who has obtained approval for plans for clinical demonstrations or biological equivalence tests, and the head of a Si/Gun/Gu, as for a pharmacy founder, or a medicinal product distributor, may, respectively, cancel approval, approval and registration, or close an

- 52 -

office of a contract manufacturing and sales business and a factory (limited to the cases where reports have been filed pursuant to Article 31 ④; hereafter the same shall apply in subparagraph 1 of Article 77), or order a prohibition against manufacture by item or against importation by item, or order a suspension of all or some of the business concerned for a specified period: Provided, That in cases of subparagraph 4, if the person is not responsible for the matter, and it is considered that some change in ingredient and formulation of the medicinal product enables its approval or registration, he/she may order the person only to change the ingredient and formulation of the medicinal product. <Amended by Act No. 8643,

Oct. 17, 2007; Act No. 10324, May 27, 2010; Act No. 10512, Mar. 30, 2011; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>

1. Where he/she falls under any of subparagraphs 1 through 4 of Article 5;2. Where it turns out that he/she falls under any subparagraph of Article 20 ⑤, or under

Article 31 ⑧ 2;2-2. Where he/she has registered, registered the alteration of, or filed a report on the

alteration of medicinal product substance under Article 31-2 ① and ③ (including the cases which are applied mutatis mutandis under Article 42 ④) by deceit or other fraudulent means;

2-3. Where he/she has failed to register the alteration of or file a report on the alteration of APIs under Article 31-2 ③ (including the cases which are applied mutatis mutandis under Article 42 ④);

3. Where he/she violates this Act or any order issued under this Act;4. Where he/she manufactures, imports or sells medicinal products, etc. which harm or are

likely to harm national public health, and medicinal products, etc. which are regarded as having no efficacy;

5. Where he/she fails to recall or take measures necessary for recall, or fails to report, or falsely reports a recovery plan pursuant to Article 39 ①;

5-2. Where he/she offers any economic interest, etc. in violation of Article 47 ②;5-3. Where he/she violates an order under Articles 71 ① and ② and 72 ① and ②; 6. Where a pharmacy founder has received a disposition of suspension of qualification of a

pharmacist or oriental pharmacist under Article 79 ②.② In cases where the facilities of the persons referred to in paragraph ①, do not meet the

standards for facilities prescribed by Articles 20 ③, 31 ① and ④, 42 ③ and 45 ②, the same as paragraph ① shall apply thereto. <Amended by Act No. 8643, Oct. 17, 2007>

③ For the criteria for an administrative disposition under paragraphs ① and ②, the criteria of revoke of approval, register, registration and permission or suspension of business, etc. of a manufacturer of medicinal products, etc., a person who has obtained product approval, a person who has registered APIs, an importer of medicinal products, etc., a person who has obtained permission for plans for clinical demonstrations or biological equivalence tests shall be prescribed by Ordinance of the Prime Minister and the criteria of revoke of license, registration, approval or suspension of qualification or business, etc. of a pharmacist, oriental pharmacist, pharmacy founder or distributer of medicinal products shall be

- 53 -

prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No.

11690, Mar. 23, 2013>

Article 76-2 (Cancellation, etc. of Designation)

① If a clinical demonstration institution, a biological equivalence test institution, a non-clinical demonstration institution, or a quality examination institution referred to in Article 34-2, 34-3, or 73 (hereinafter referred to as "examination institution, etc.") falls under any of the following subparagraphs, the Minister of Food and Drug Safety or the head of a Si/Gun/Gu may cancel the designation of such institution, or may order suspension of business for up to nine months: Provided, That in cases of subparagraphs 1, 2 (limited to cases of intention and serious negligence) and 5, he/she shall cancel the designation of such institution: <Amended by Act No. 11690, Mar. 23, 2013>

1. Where designation has been made by fraud or other wrongful means;2. Where the clinical demonstration results, biological equivalence test results, non-clinical

demonstration results, or quality examination results under Article 34-2 ③, 34-3 ③, or 73 ③ have been falsely prepared or issued;

3. Where the designation requirements referred to in Article 34-2 ② and ④, 34-3 ② and ④, or 73 ② and ④ have not been satisfied:

4. Where the matters to be observed referred to in Article 34-2 ③, 34-3 ③, or 73 ③ have not been observed;

5. Where business has been performed during a business suspension period. ② No person whose designation has been canceled pursuant to paragraph ① shall be

designated again within two years from the date on which the designation is cancelled. ③ The criteria for administrative disposition under paragraph ① shall be prescribed by

Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 76-3 (Cancellation of Registration of OTC Drug Seller)

① In cases where an OTC drug seller falls under any of the following subparagraphs, the head of a Si/Gun/Gu may cancel the registration of such OTC drug seller: Provided, That in cases of subparagraphs 1 and 3 through 6, he/she shall cancel the registration of such OTC drug seller:1. Where registration has been made by fraud or other wrongful means;2. Where he/she fails to perform the recall or measures necessary for the recall in violation

of the former part of Article 39 ①; 3. Where the registration requirements referred to in Article 44-2 ② have not been

satisfied;4. Where he/she fails to make alteration registration or alteration registration has been made

by fraud or other wrongful means in violation of Article 44-2 ③;5. Where he/she fails to receive education in violation of Article 44-3 ①;6. Where he/she fails to observe the matters to be observed by designated OTC drug seller

- 54 -

referred to in Article 44-4 (limited to the case where he/she has violated more than 3 times over the course of 1 year);

7. Where the matters necessary to establish the distribution system and maintain sales order in violation of Article 47 ①;

8. Where he/she sells medicinal products at a place, other than a registered place in violation of Article 50 ①;

9. Where he/she has failed to comply with a request for submission of documents and information under Article 69 ① 1 or rejected, obstructed or evaded inspection, inquiry and collection under Article 69 ① 2 and 3;

10. Where he/she has failed to comply with an order, etc. of scrapping under Article 71 ① or an order of the recall and scrapping under Article 71 ② or to rejected, obstructed or evaded the disposition of the recall and scrapping under Article 71 ③;

11. Where he/she has failed to comply with an order of announcement pursuant to Article 72 ②.

② A person whose registration has been cancelled under paragraph ① shall not be registered as a designated OTC drug seller within one year from the date of cancellation.

[This Article Newly Inserted by Act No. 11421, May. 14, 2012]

Article 77 (Hearings)

The Minister of Health and Welfare, the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu who desires to render a disposition falling under any of the following subparagraphs shall hold a hearing: <Amended by Act No. 8643, Oct. 17, 2007; Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11421, May. 14, 2012; Act No. 11690, Mar. 23, 2013>

1. Cancelling approval, permission and registration, or closure of an office of a contract manufacturing and sales business and a factory, or issuing orders to prohibit manufacturing or importing of items under Article 76;

1-2. Cancellation of registration under Article 76-3;2. Cancelling designation under Article 76-2 ①; 3. Cancelling a license under Article 79 ① or ②.

Article 78 (Pharmaceutical Inspectors)

① Pharmaceutical inspectors shall be assigned to the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, Cities/Dos, Sis/Guns/Gus (referring to autonomous Gus of the Special Metropolitan City and Metropolitan Cities) in order to have them perform the duties of pertinent public officials under Articles 69 ① and 71 ②. <Amended by Act

No. 11690, Mar. 23, 2013>

② Pharmaceutical inspectors shall be appointed by the Minister of Health and Welfare, the Minister of Food and Drug Safety, Mayors/Do Governors or the heads of Sis/Guns/Gus from among public officials belonging to the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, Cities/Dos or Sis/Guns/Gus. <Amended by Act No. 11690, Mar. 23,

- 55 -

2013>

③ Necessary matters concerning qualification, appointment, etc. of pharmaceutical inspectors shall be prescribed by Ordinance of the Prime Minister after consultation with the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010;

Act No. 11690, Mar. 23, 2013>

Article 79 (Cancellation, etc. of Pharmacist's or oriental pharmacist's License)

① If a pharmacist or oriental pharmacist falls under any of subparagraphs 1 through 4 of Article 5, the Minister of Health and Welfare shall cancel his/her license. <Amended by Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

② If a pharmacist or oriental pharmacist falls under any of the following subparagraphs, the Minister of Health and Welfare may cancel his/her license or order the suspension of qualification as a pharmacist or oriental pharmacist, by up to one year: <Amended by Act

No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

1. When he/she violates the Acts and subordinate statutes concerning pharmaceutical affairs or violates the criteria for ethics prescribed by Ordinance of the Ministry of Health and Welfare;

2. When he/she forges or alters the relevant documents or demands medicinal product expenses by fraudulent and other illegal means.

③ In cases where a pharmacist or a oriental pharmacist falls under any of the following subparagraphs, the Minister of Health and Welfare may order the suspension of qualification as a pharmacist or a oriental pharmacist by up to one year: <Newly Inserted by Act No. 9123,

Jun. 13, 2008; ; Act No. 9932, Jan. 18, 2010; Act No. 10324, May 27, 2010>

1. Where he/she has been employed by a person disqualified as a pharmacy founder and performs affairs of a pharmacist or a oriental pharmacist;

2. Where he/she receives any economic interest, etc. in violation of Article 47 ③.④ Even though a pharmacist's or oriental pharmacist's license is cancelled under paragraphs ①

and ②, if a ground for the cancellation ceases to exist, the Minister of Health and Welfare may regrant the license, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>

Article 79-2 (Pharmaceutical Association and Oriental Pharmacy Association's

Request, etc. for Disposition of Qualification Suspension)

If a pharmacist or oriental pharmacist falls under the cases of violating the criteria for ethics under Article 79 ② 1, the head of the Pharmaceutical Association or theoriental pharmacy association may require the Minister of Health and Welfare to suspend qualification of such pharmacist or oriental pharmacist, after deliberation and resolution by the Ethics Committee of the Pharmaceutical Association or the oriental pharmacy association.

[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 80 (Renewal of Certificate of License, approval, Registration, etc.)

- 56 -

A person who has obtained a pharmacist's license or a oriental pharmacist's license, a person who has registered opening of a pharmacy, a person who has obtained approval of sales business of medicinal products or OTC drugs shall renew his/her certificate of license, approval, registration as prescribed by Ordinance of the Ministry of Health and Welfare and a person who has obtained approval of a manufacture business or has registered on contract manufacturing and sales business of medicinal products, etc. shall renew his/her certificate of license, approval and registration as prescribed by Ordinance of the Prime Minister.

[This Article Wholly Amended by Act No. 11690, Mar. 23, 2013]

Article 81 (Disposition of Penalty Surcharge)

① If a manufacturer, a person who has obtained product approval of medicinal products, etc., an importer of medicinal products, etc., a pharmacy founder or a distributor of medicinal products is to be subject to the disposition of business suspension under Article 76, the Minister of Food and Drug Safety, the Mayor/Do governor or the head of Si/Gun/Gu may impose a penalty surcharge not exceeding 200 million won (50 million for pharmacy founders or herb druggists) in lieu of such disposition as prescribed by Presidential Decree. In such cases, if a pharmacy founder who has been subject to the disposition of suspension of license of pharmacist or oriental pharmacist under Article 79 ② 2 comes to be subject to the disposition of business suspension under Article 76 ① 5, the penalty surcharge replacing it shall not be imposed in excess of three times. <Amended by Act No. 8643, Oct.

17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

② The amount of penalty surcharge according to categories of offenses against which penalty surcharge as referred to in paragraph ① is imposed and the degree thereof, and other necessary matters shall be prescribed by Presidential Decree.

③ When necessary for the collection of penalty surcharge, the Minister of Food and Drug Safety, the Mayor/Do governor or the head of Si/Gun/Gu, may request the head of competent tax office to provide taxation information by a paper stating the matters in the following subparagraphs:1. Character of tax payer;2. Purpose of use; and3. Data on sales on which the imposition of penalty surcharge shall be based.

④ If the person who has to pay the penalty surcharge pursuant to paragraph ① fails to pay it within the time limit of payment, the Minister of Food and Drug Safety, the Mayor/Do governor or the head of Si/Gun/Gu shall cancel the disposition of imposition of penalty surcharge pursuant to paragraph ①, and shall render disposition of business suspension pursuant to Article 76 ① or ②, or shall collect it according to the examples of disposition of national taxes or local taxes in arrears as prescribed by Presidential Decree: Provided, That it is impossible to render disposition of business suspension pursuant to Article 76 ① or ② due to closedown, etc. pursuant to Article 40, it shall be collected according to the examples of disposition of national taxes or local taxes in arrears. <Amended by Act No.

11690, Mar. 23, 2013>

- 57 -

⑤ The amount collected as penalty surcharge under paragraphs ① and ④ shall revert to the State or local government to which the collecting agency belongs.

Article 82 (Fees)

① A person who falls under the following subparagraphs shall pay a fee, as determined by Ordinance of the Ministry of Health and Welfare. The same shall also apply to the modification of license, registration or approval, etc. prescribed by Ordinance of the Minister of Health and Welfare:1. A person who intends to obtain a license of pharmacist and oriental pharmacist under

the provisions of Article 3 and 4;2. A person who intends to file for registration for establishment of pharmacy under the

provisions of Article 20;3. A person who intends to register as a distributor of OTC drugs under Article 44-2; 4. A person who intends to obtain approval for distribution of drugs under Article 45;5. A person who intends to obtain information on distribution of drugs;6. A person who intends to apply for the national examination for pharmacists, etc.;7. A person who intends to request other matters prescribed by Ordinance of the Ministry

of Health and Welfare.② Regarding the affairs under the jurisdiction of the Ministry of Food and Drug Safety, a

person who falls under the following subparagraphs shall pay a fee, as prescribed by Ordinance of the Prime Minister. The same shall also apply to the modification of approval, renewal, registration, report, permission and other matters prescribed by Ordinance of the Prime Minister.1. A person who intends to apply for approval, renewal, registration, report, permission,

designation and preliminary examination;2. A person who intends to determine the standards of new products;3. A person who requests other matters prescribed by Ordinance of the Prime Minister.

[This Article Wholly Amended by Act No. 11690, Mar. 23, 2013]

CHAPTER VIII SUPPLEMENTARY PROVISIONS

Article 83 (Subsidization from National Treasury)

As prescribed by Presidential Decree, the Minister of Health and Welfare and the Minister of Food and Drug Safety may subsidize research funds to the manufacturers of medicinal products, etc. who have contributed to exportation, or to the institutions, etc. that contribute to the national health by carrying out research projects on the safety of medicinal products, etc. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010, Act No. 11690, Mar. 23, 2013>

- 58 -

Article 84 (Delegation and entrustment of Authority)

① As prescribed by Presidential Decree, the authority of the Minister of Health and Welfare under this Act may be partially delegated to the director of the Korea Centers for Disease Control and Prevention or the Mayor/Do Governor.

② As prescribed by Presidential Decree, the authority of the Minister of Food and Drug Safety under this Act may be partially delegated to the Commissioner of the local Korea Food and Drug Administration, the Director General of the National Institute of Food and Drug Safety Evaluation or the Mayor/Do governor.

③ As prescribed by Presidential Degree, the authority of the Mayor/Do Governor under this Act may be partially delegated to the head of a Si/Gun/Gu or the head of a community health center.

④ As prescribed by Presidential Decree, the authority of the head of a Si/Gun/Gu under this Act may be partially delegated to the head of a community health center.

⑤ The Minister of Health and Welfare and the Minister of Food and Drug Safety may entrust an organization or the Institute of Drug Safety and Risk Management prescribed in Article 67 with part of pharmaceutical affairs under this Act, as prescribed by Presidential Decree.

[This Article Wholly Amended by Act No. 11690, Mar. 23, 2013]

Article 85 (Special Cases concerning Medicinal Products, etc. for Animals)

① Drugs or therapeutic devices, the purpose of which is to be used exclusively for animals, under the jurisdiction of the Minister of Health and Welfare and the Minister of Food and Drug Safety under this Act, shall be matters under the jurisdiction of the Minister of Agriculture, Food and Rural Affairs and the Minister of Maritime Affairs and Fisheries, and "Minister of Health and Welfare" or "Minister of Food and Drug Safety" in the corresponding provisions of this Act shall be construed as "Minister of Agriculture, Food and Rural Affairs" or "Minister of Maritime Affairs and Fisheries", and "Ordinance of the Ministry of Health and Welfare" or "Ordinance of the Prime Minister" shall be construed as "Ordinance of the Ministry of Agriculture, Food and Rural Affairs" or "Ordinance of the Ministry of Maritime Affairs and Fisheries". In such cases, when the Minister of Agriculture, Food and Rural Affairs issues Ordinance of the Ministry of Agriculture, Food and Rural Affairs or the Minister of Maritime Affairs and Fisheries issues Ordinance of the Ministry of Maritime Affairs and Fisheries, he/she shall consult with the Minister of Health and Welfare or the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23,

2013>

② With respect to the medicinal products for animals used for the diagnosis and treatment or prevention of animal's diseases, and designated as ones that may stay in an animal's body and inflict danger or injury to human health, the Minister for Food, Agriculture, Forestry and Fisheries may determine the standards for use of animal medicinal products, such as animals for which such medicinal products are used, direction, dosage, the period banning its use, etc. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 11690, Mar. 23, 2013>

③ Any person who desires to use animal medicinal products, the using standards of which are

- 59 -

determined under paragraph ②, shall observe such standards: Provided, That where he/she uses them pursuant to the diagnosis or prescription of a veterinarian or a certified marine disease manager, he/she may choose not to observe such standards.

④ Notwithstanding Article 44, a person who has established a veterinary hospital as prescribed by the Veterinarians Act, may sell animal medicinal products used for the treatment of animals to any person who rears them, or may purchase medicinal products for the purpose of treating animals from any pharmacy founder under the proviso to Article 50 ②. In such cases, a person who has established a veterinary hospital shall prepare and retain sale and purchase records, as prescribed by Ordinance of the Ministry for Food, Agriculture, Forestry and Fisheries. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 11690, Mar. 23, 2013>

⑤ Notwithstanding Article 44, a person who has established a marine disease management office as prescribed by the Fish Farming Development Act may sell medicinal products used for the treatment of marine life to any person who cultivates such marine life. <Amended by Act No. <Amended by Act No. 10888, Jul. 21, 2011>

⑥ No person who has obtained permission for a wholesaler of medicinal products for animals under this Act shall distribute any of the following medicinal products for animals, which are determined and publicly notified by the Minister of Agriculture, Food and Rural Affairs and the Minister of Maritime Affairs and Fisheries, without a prescription of a veterinarian or a certified marine disease manager: Provided, That the same shall not apply to cases where such medicinal products are distributed among a founder of a veterinary hospital, a founder of a marine disease management office, a pharmacy founder, or a wholesaler of medicinal products for animals: <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690,

Mar. 23, 2013>

1. Medicinal products for animals which are likely to do harm to human and animal health if misused or abused;

2. Medicinal products for animals which require expertise of a veterinarian or a certified marine disease manager;

3. Medicinal products for animals deemed likely to cause disorder in light of their dosage form and pharmacological action.

⑦ A founder of a pharmacy may sell medicinal products for animals falling under any of the subparagraphs of paragraph ⑥ without a prescription of a veterinarian or a certified marine disease manager: Provided, That the same shall not apply to medicinal products for animals falling under any of the following subparagraphs as prescribed by the Minister of Agriculture, Food and Rural Affairs or the Minister of Maritime Affairs and Fisheries: <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>

1. An antibiotic substance preparation for injection;2. A biological preparation for injection.

⑧ Notwithstanding paragraphs ⑥ and ⑦, a person who sells medicinal products for animals pursuant to this Act may sell medicinal products for animals in subparagraphs of paragraph ⑥ without a prescription of a veterinarian or a certified marine disease manager, if he/she falls under any of the following cases. In such cases, matters on the methods for sale, the

- 60 -

management of records and the scope of purchasers, matters to be observed, and other necessary matters shall be prescribed by Ordinance of the Ministry of Agriculture, Food and Rural Affairs or by Ordinance of the Ministry of Maritime Affairs and Fisheries: <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>

1. Where such medicinal products are sold to a livestock farmer or a fishing household cultivating marine life in an island or a remote place prescribed by the Minister of Agriculture, Food and Rural Affairs or the Minister of Maritime Affairs and Fisheries:

2. Where the use of medicinal products for animals has been ordered by the Minister of Agriculture, Food and Rural Affairs or the Minister of Maritime Affairs and Fisheries, a Mayor/Do Governor, or the head of a Si/Gun/Gu for purposes of emergent quarantine pursuant to Article 15 of the Act on the Prevention of Contagious Animal Diseases or Article 13 of the Aquatic Life Disease Control Act.

⑨ A person who sells medicinal products for animals pursuant to this Act shall observe the matters determined by Ordinance of the Ministry of Agriculture, Food and Rural Affairs or by Ordinance of the Ministry of Maritime Affairs and Fisheries to establish the distribution system and to maintain sales order of medicinal products for animals, such as prohibition of an act of collusion, designation of sales places, and management of records. <Newly

Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>

Article 86 (Projects for Relief of Injury from Side Effects of Medicinal

Products)

① An organization composed of manufacturers, persons who have obtained product approval or importers of medicinal products shall carry out research projects to support the improvement of safety of medicinal products and the development of new drugs, so as to relieve any injury caused by the side effects of medicinal products. <Amended by Act No. 8643, Oct. 17,

2007>

② Manufacturers, persons who have obtained product approval or importers of medicinal products shall bear the expenses incurred in the projects referred to in paragraph ①. <Amended by Act No. 8643, Oct. 17, 2007>

③ For the purposes of the projects referred to in paragraph ①, the Government may provide a subsidy within budgetary limits.

④ Matters necessary for the projects referred to in paragraph ① shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan.

18, 2010; Act No. 11690, Mar. 23, 2013>

Article 87 (Prohibition of Leakage of Secret)

① A pharmacist or a oriental pharmacist shall not leak other person's secrets which he/she has learned while preparing and selling medicinal products except as otherwise provided in this Act or other Acts and subordinate statutes.

② A person who has learned a secret about business of a person who has obtained product approval of medicinal products, an importer and a wholesaler, etc. of medicinal products on

- 61 -

business shall not break such secret or shall not use such secret for the purpose other than business purpose. <Newly Inserted by Act No. 8643, Oct. 17, 2007>

Article 88 (Protection of Material Furnished)

① With respect to data furnished pursuant to Articles 31, 31-2, 32 through 34, 35-2, or 42, when a person who has furnished such data files a written request for its protection, the Minister of Food and Drug Safety shall not make such data public: Provided, That where the Minister of Food and Drug Safety deems it necessary to disclose such data for public interest, he/she may disclose it. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar.

23, 2013>

② Any person who has read or examined furnished data for which a written request is filed for its protection under the provisions of paragraph ① shall not make public the contents of such data that he/she has learned as a result of such reading and examination.

Article 89 (Succession of Status, etc. of Manufacturer, etc.)

① When a manufacturer, a person who has obtained product approval of medicinal products, etc., a person who has registered on contract manufacturing and sales business, a distributer of medicinal products (excluding herb druggists), or a person who was designated as an examination institution, etc. (hereinafter referred to as "manufacturer, etc." in this Article and Article 89-2) dies or a merger of manufacturers, etc. who are juristic persons takes place, the successor, transferee, corporation surviving such merger or corporation incorporated by such merger shall succeed the status of the manufacturer, etc.: Provided, That the same shall not apply to the case where such transferee, such corporation surviving the merger or such corporation incorporated by the merger falls under any case of the following subparagraphs: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10512, Mar. 30,

2011; Act No. 10788, Jun. 7, 2011>

1. A manufacturer, a person who has obtained product approval of medicinal products, etc., and a person who has registered on contract manufacturing and sales business: Where it falls under any of subparagraphs of Article 31 ⑧;

2. A distributer of medicinal products: Where it falls under any of subparagraphs of Article 46.

② Where a manufacturer, a person who has obtained product approval, a person who has registered on contract manufacturing and sales business, or an importer of medicinal products, etc. has transferred his/her business on medicinal products, etc. for which approval has been obtained or a registration has been filed by manufacture and import items pursuant to Article 31 ② through ④ or 42 ①, the manufacturer, the person who has obtained product approval, the person who has filed a registration on contract manufacturing and sales business, or the importer of medicinal products, etc. who takes over such business shall succeed the status of the former manufacturer, person who has obtained product approval, person who has filed a registration on contract manufacturing and sales business, importer of medicinal products, etc. with respect to approval and registration of

- 62 -

the relevant items. <Amended by Act No. 10788, Jun. 7, 2011>

③ A person who has succeeded to the status of the manufacturer, etc. pursuant to paragraphs ① and ② shall file a report with the Minister of Food and Drug Safety (referring to the head of a Si/Gun/Gu in cases of a distributer of medicinal products) according to the classification in the following subparagraphs within one month from the date of succession: Provided, That where the successor who succeeded the status of the manufacturer, etc. pursuant to paragraph ① falls under any subparagraph of paragraph ①, he/she shall transfer such status to another person within six months from the date when succession started. <Amended by Act No. 11690, Mar. 23, 2013>

1. A manufacturer of medicinal products, A person who has obtained product approval and a person who has registered on contract manufacturing and sales business of medicinal products, etc. shall observe as prescribed by Ordinance of the Prime Minister;

2. A person who has succeeded to the status of the distributor of medicinal products, etc. shall observe as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012>

Article 89-2 (Succession of Effects of Disposition of Administrative Sanctions)

Where the status has been succeeded pursuant to Article 89, effects of the administrative disposition on the previous manufacturer, etc. and importer shall be succeeded to the transferee, a juristic person which exists after a merger, or to a juristic person established after a merger for one year from the date on which such disposition took place, and where the procedures for administrative disposition are underway, the procedures for disposition of administrative sanctions may proceed for the transferee, the juristic person which exists after a merger, or to the juristic person established after a merger: Provided, That in cases where a new manufacturer, etc. (excluding the succession of the status by inheritance) and an importer succeeds business, the same shall not apply, unless he/she knows about such disposition or violation.[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]

Article 90 (Bounty)

A bounty may be paid to any person who has whistle-blown or tipped off the fact of violating the provisions of Article 23, 24 ① and ②, 26 ①, 27 ① and ③, and 50 ① and ② to any supervisory agency or any investigative agency under the conditions as prescribed by Presidential Decree. <Amended by Act No. 11421, May. 14, 2012>

Article 91 (Creation of Korea Orphan Drug Center)

① The Korea Orphan Drug Center (hereinafter referred to as the "Center") shall be created to perform the work of furnishing information with respect to medicinal products which have the rare subject of their application and are required to be urgently imported because of the lack of their substitute medicinal products and other medicinal products used to treat rare diseases (hereinafter referred to as "orphan drugs, etc.") and supplying (including the duties

- 63 -

of preparation and dosage of medicinal products; hereinafter the same shall apply) such medicinal products.

② The Center shall be a corporation.③ The provisions governing the juridical foundation of the Civil Act shall apply mutatis

mutandis to the Center except as otherwise provided for in this Act.④ Necessary matters concerning the operation, etc. of the Center created under paragraph ①

shall be prescribed by Presidential Decree.

Article 92 (Projects of Center)

① The Center shall conduct the projects falling under the following subparagraphs: <Amended

by Act No. 11690, Mar. 23, 2013>

1. The project of gathering information pertaining to the orphan drugs, etc. and building a computer network;

2. The project of supplying the orphan drugs, etc.; in this case, the president of the Center shall install a dispensary in the Center, designate a pharmacist from among the staff of the Center and have him/her take charge of the business; and

3. Other projects related to the orphan drugs, etc., which are approved by the Minister of Food and Drug Safety.

② the Minister of Food and Drug Safety may, when he/she deems it necessary for the Center to perform the work specified in paragraph ①, provide the Center with financial assistance, etc. <Amended by Act No. 11690, Mar. 23, 2013>

CHAPTER IX PENAL PROVISIONS

Article 93 (Penal Provisions)

① A person who falls under any of the following subparagraphs shall be punished by imprisonment for a term of not more than five years, or by a fine not exceeding twenty million won: <Amended by Act No. 8643, Oct. 17, 2007>

1. A person who has lent his/her license to other person in violation of Article 6 ③;2. A person who has established a pharmacy in violation of Article 20 ①;3. A person who has violated Article 23 ①;4. A person who has failed to obtain approval or to file registration in violation of the

provisions of Article 31 ① through ④;5. A person who has not obtained approval, has not filed registration, has not obtained

approval for alteration, or has not filed registration of alteration in violation of Article 42 ①;

6. A person who has violated Article 43;7. A person who has violated Article 44 ①;8. A person who has sold medicinal products without obtaining approval pursuant to Article

- 64 -

44 ② 2;9. A person who has violated Article 53 ①; or10. A person who has violated Article 61 (including the case where it applies mutatis

mutandis in Article 66).② As for the punishment referred to in paragraph ①, imprisonment and fine may be imposed

concurrently.

Article 94 (Penal Provisions)

① A person who falls under any of the following subparagraphs shall be punished by imprisonment for a term of not more than three years, or by a fine not exceeding ten million won: Provided, That any person who has violated Article 87 ① may be charged only when an accusation is filed against him/her: <Amended by Act No. 8643, Oct. 17, 2007;

Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11421, May. 14, 2012>

1. A person who has violated Article 3 ③ or 4 ③;2. A person who has committed an act of collusion in violation of Article 24 ②;3. A person who has violated Article 34 ① or ③ 2 through 4, or a person who has

violated the order under Article 34 ⑥; 4. A person who has violated Article 37 ③ (including the case where it applies mutatis

mutandis in Article 42 ④);5. A person who has violated Article 45 ⑤;6. A person who has sold medicinal products after breaking the seal of the container or

package in violation of the main sentence of Article 48;7. A person who has sold, stored or displayed medicinal products in violation of Article

49;8. A person who has violated Article 50 ① (including cases applicable mutatis mutandis in

Article 44-5 ①);9. A person who has sold, manufactured, imported, stored or displayed medicinal products

in violation of Article 62 (including the case where Article 66 applies mutatis mutandis);9-2. A person who has divulged a secret in violation of Article 68-9; 10. A person who has rejected an order to manufacture medicinal products or an order to

start work without justifiable reasons in violation of Article 70 ②;11. A person who has violated an order pursuant to Articles 71 ① and ② (including cases

applicable mutatis mutandis in Article 44-5 ①) and 72 ① and ② (including cases applicable mutatis mutandis in Article 44-5 ①), or has rejected, obstructed or evaded the recall and scrapping of articles carried out by the relevant public official pursuant to Article 71 ③ (including cases applicable mutatis mutandis in Article 44-5 ①), and other necessary disposition;

12. A person who has violated Article 87 or 88 ②.② As for the punishment referred to in paragraph ①, imprisonment and fine may be imposed

concurrently.

- 65 -

Article 94-2 (Penal Provisions)

A person who violates Article 47 ② and ③ shall be punished by imprisonment for not more than two years or by a fine not exceeding thirty million won. In such cases, any economic interest, etc. acquired shall be confiscated or where it is impossible to confiscate such economy interest, etc., the value thereof shall be collected.[This Article Newly Inserted by Act No. 10324, May 27, 2010]

Article 95 (Penal Provisions)

① A person who falls under any of the following subparagraphs shall be punished by imprisonment for not more than one year, or by a fine not exceeding three million won: <Amended by Act No. 8558, Jul. 27, 2007; Act No. 8643, Oct. 17, 2007; Act No. 10324, May 27, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11421, May. 14, 2012>

1. A person who fails to make registration of establishment, in violation of Article 20 ②;2. A person who violates Article 21 ① and ②;3. A person who violates Article 23 ②, ③, ④, ⑥ and ⑦;4. A person who refuses to fill a prescription without justifiable grounds, in violation of

Article 24 ①;5. A person who fills a prescription, in violation of Article 26 ①;6. A person who violates Article 27 ①, ③ and ④;6-2. A person who has falsely prepared or issued the clinical demonstration results,

biological equivalence test results, non-clinical demonstration results, or quality examination results under Article 34-2 ③, 34-3 ③, or 73 ③;

7. A person who fails to perform affairs of safety control, in violation of Article 36, 37 ② (including cases applicable mutatis mutandis in Article 42 ④) or 37-3 ① (including cases applicable mutatis mutandis in Article 42 4));

8. A person who violates Article 47 ① (including cases applicable mutatis mutandis in Article 44-5 ①) or ④, or 85 ⑨;

9. A person who sells prescription drugs, in violation of Article 50 ②;10. A person who violates Article 60, 64 ① or 68.11. A person who has sold medicinal products for animals without a prescription in

violation of Article 85 ⑥ and ⑦; ② As for the punishment referred to in paragraph ①, imprisonment and fine may be imposed

concurrently.

Article 95-2 (Penal Provisions)

A person who has violated Article 26 ② shall be punished by a fine not exceeding three million won.[This Article Newly Inserted by Act No. 8558, Jul. 27, 2007]

Article 96 (Penal Provisions)

Any person who falls under any of the following subparagraphs shall be punished by a fine

- 66 -

not exceeding two million won: Provided, That any person who has violated the provisions of Article 30 ② may be charged only when an accusation is filed against him/her: <Amended by

Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11421, May. 14, 2012>

1. A person who has violated the provisions of Article 24 ③;2. A person who has violated Articles 28, 29 or 30 ① and ②;3. A person who has violated Articles 37 ①, 37-3 ② or 38 ①;4. A person who has violated Articles 56 ①, 57, 58, 63 (including the case where it

applies mutatis mutandis in Article 66), or 65 ①;5. A person who has refused, obstructed or evaded inspection, inquiry, collection, etc. by

the competent public official pursuant to Article 69 ① (including cases applicable mutatis mutandis in Article 44-5 ①); or

6. A person who has violated an order of report, announcement, inspection, repair, alteration, etc. under Articles 69 ① (including cases applicable mutatis mutandis in Article 44-5 ①) and 72 ③, ④, 73 through 75.

Article 97 (Joint Penal Provisions)

Where the representative of a juristic person, or any agent, employee or other person employed by the juristic person commits an offense under Article 93, 94, 94-2, 95, 95-2, or 96 with regard to business affairs of such juristic person or individual, not only the violator shall be punished but also the juristic person or individual shall be punished with a penalty in the applicable provisions: Provided, That the same shall not apply to cases where the juristic person or individual has not been negligent in providing significant caution and supervision for relevant business to prevent such offense.

[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]

Article 98 (Fines for Negligence)

① A person who falls under any of the following subparagraphs, shall be punished by a fine for negligence not exceeding one million won: <Amended by Act No. 8643, Oct. 17, 2007; Act

No. 10788, Jun. 7, 2011; Act No. 11421, May. 14, 2012>

1. A person who fails to file a report of a pharmacist or oriental pharmacist, in violation of Article 7;

2. A person who fails to receive training and education prescribed in Article 15;3. A person who fails to observe the matters necessary for the management of a pharmacy,

in violation of Article 21 ③;4. A person who fails to report the discontinuance of business, etc., in violation of Article

22 or 40;4-2. A person who fails to receive education in violation of Articles 37-2 (including the

mutatis mutandis application under Article 42 ④) and 73-3 ①; 5. A person who fails to report the actual results of production or actual imports, etc. of

medicinal products, etc., in violation of Article 38 ② (including cases applicable mutatis

- 67 -

mutandis in Article 42 ④);6. Deleted. <by Act No. 11251, Feb. 1, 2012> 6-2. A person who fails to report the preparation, etc. of pharmacy medication or

dispensary medication in violation of Article 41 (1);6-3. A person who fails to report the discontinuance, suspension or reopen in violation of

the main sentence of Article 44-2 ④;6-4. A person who fails to receive education in violation of Article 44-3 ②;7. A person who fails to observe the matters to be observed by OTC drug seller in

violation of 44-4;7-2. A person who fails to submit details of supply of medicinal products in violation of

Article 47-2 ② (including cases applicable mutatis mutandis in Article 44-5 ②);7-3. A person who fails to state prices of medicinal products on the containers or packages

of medicinal products in violation of Article 56-2 (including cases applicable mutatis mutandis in Article 44-5 ①) or Article 65-2;

7-4. A person who fails to file a report on a harmful case in violation of Article 68-8; 7-5. A person who has used the name, the Korea Institute of Drug Safety and Risk

Management or a name similar thereto in violation of Article 68-10; 8. Deleted. <by Act No. 11251, Feb. 1, 2012> 9. A person who fails to renew a certificate of license, approval or registration, in violation

of Article 80;10. A person who fails to observe the standards for use of animal medicinal products, in

violation of Article 85 ③.② Fines for negligence referred to in paragraph ① shall be imposed and collected by the

Minister of Health and Welfare, the Minister of Food and Drug Safety, Mayors/Do Governors or the heads of Sis/Guns/Gus, as prescribed by Presidential Decree. <Amended by

Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>

Paragraphs ③ through ⑤ Deleted. <by Act No. 10788, Jun. 7, 2011>