Draft Law of Kyrgyz Republic on Medicinal Products

Syrdybaev Suyunbek, Head of expert group of ISWG of MoH KR

4th Forum of МеТА Kyrgyz RepublicBishkek, 8 December 2015

Dated 8 July 2014 # 376On the approval of Program of Government of Kyrgyz Republic for the development in sphere of medicines circulation in Kyrgyz Republic for 2014-2020

Approved:

-Program of Government of Kyrgyz Republic for the , development in sphere of medicines circulation in Kyrgyz Republic for 2014-2020;- Action Plan for the implementation of the Program of the Government of the Kyrgyz Republic for the development of the sphere of circulation of medicines in the Kyrgyz Republic for 2014-2020.• Ministry of Health is to carry out the overall coordination of the

implementation

GOVERNMENT of KYRGYZ REPUBLICDECREE

New LawOn medicinal products:

A large number of changes due to:• Law on normative legal acts;• Law on licensing and permitting activities;• Addressing the causes of the political system and

corruption in government• The unification of terminology in the Community• Segregation of medical devices, medical equipment and

veterinary products in the individual legal acts;• The new structure of the law, based on the stages of the

medicine circulation on the market.

Chapter IGeneral provisions

Offered:• Leave 5 Articles, but change the content

and titles of certain articles;• expand the list of basic definitions

Article 4. Definitions used in the sphere of medicinal products circulation

• Title of the article altered - more commonly designated sphere

• Introduced new definitions necessary for the normal functioning of the circulation of medicines, such as biosimilars, active pharmaceutical ingredients (active ingredient), immunological drug, general pharmacopoeial article, good regulatory practice, Orphan drugs, Reference drug, pharmaceutical substance, Pharmacopoeia Analysis etc.

• In general the number of definitions increased from 39 to 79

Article 5. Guiding principles of the National Medicines Policy

• Amendments made according to new State Program for development in the sphere of medicine circulation, such as:

• ensure the orderly citizens' access to medicines which is a specific product because of the possible harm to human health and life, as well as requiring special monitoring of transportation, storage, production, manufacture, sale and utilization

Chapter II Article 6. State regulation of relations arising in the sphere of medicine circulation

State regulation described in details:

• The new version lists 16 methods of state regulation.

• Introduced powers of the Government to determine the pricing policy for EML

• Added Article 10 Circulation of the medicinal products.

Article 8. The mechanism of implementation of Powers of the Government in health

• All the powers of a public authority are gathered in this article;

• Amended to provide mandatory information to the public through its publication on the official website;

• Functions of the Ministry of Health, as noted by the Ministry of Justice, will be specifically itemized in the Regulation on the Ministry.

Chapter III State control and supervision over the quality, safety and efficacy of medicines

• Article 10. Registration and confirmation of registration of medicinal products

• Article 11. Medicinal products subject to mandatory registration

• Article 12. Medicinal products marketable in the Kyrgyz Republic without registration

• Article 13. State Register of Medicines of the Kyrgyz Republic• Article 14. Certificate of the medicinal product registration• Article 15. Revocation of the medicinal product registration

Chapter III State control and supervision over the quality, safety and efficacy of medicines

• Article 16. Cancellation of the medicinal product registration• Article 17. Ensuring interoperability (therapeutic

equivalence) generic medicines• Article 18. Control of pharmaceutical market• Article 19. Pharmaceutical inspection• Article 20. Pharmacovigilance• Article 21. Storage of medicinal products• Article 22. Rules of handling with unfit medicines for sale

and use• Article 23. Dispute settlement in the field of medicinal

products

The essence of the innovations in the system of registration of drugs (continued):

Article 13. State Register of Medicines of the Kyrgyz Republic:• State Register of Medicines of the Kyrgyz Republic is

unified information system;• The formation and maintenance of the Register is

carried out by Ministry of Health;• The Register is maintained personified change history

registry records with the date and time of the recordings, their changes and exceptions. Removing the data from a single register is not allowed.

• The information contained in the records are open and accessible to public

The essence of the innovations in the system of registration of drugs (continued):

Article 14. Certificate of the medicinal product registration• Certificate of registration of the ,medicinal product

with indication of forms and dosage is issued with no fixed term (termless), except for the Certificate of registration issued for five years and for newly registered medicinal products in the Kyrgyz Republic.

• After five years following the newly registered drug are over, the authorized body issues termless registration certificate conditioned that the registration status is confirmed.

Other innovations in the field of registration

• Introduced responsibility of the expert• mandatory return export of medicinal

products that have not been certified by the person who imported medicines

• transparency and accountability is provided through the legislative consolidation of mandatory provision of information, management of the state register

Article 18. Control over the pharmaceutical market

• State control over the observance of the standards, rules, procedures for storing, selling and accounting requirements to the authorized medicinal products, as well as the medicines in circulation without registration by the subjects of pharmaceutical activity, carried out in the following forms:

• 1) pharmaceutical inspection;• 2) pharmacovigilance.• The procedures for supervision and enforcement are

laid down in a Governmental Decree.

Chapter V. Rights and responsibilities of citizens and pharmaceutical market entities

Article 29. Compensation of harm to health of citizens due to use of medicinal products:• more and more clearly defined the subjects of

harm;• added harm to life or health of people, the

environment as a result of violations of rules of the medicinal products destruction;

Chapter VI. System of ensuring access to medicinal products

• Editorial changes to streamline the logic of presentation. For example, quality control is transferred to the chapter on quality control.

Chapter VII Participation in the pharmaceutical activities

Offered:• Article 33. Pharmaceutical activity • Статья 34. Permission to pharmaceutical

practice

Chapter VIII. Development, preclinical and clinical trials (studies) of new medicines

• Chapter greatly reduced and the detailed requirements for the development, preclinical and clinical studies (tests) of new drugs proposed to consolidate the regulations.

• A ban on the clinical trials on children and pregnant women

Chapter IX. Development and production of medicinal products

Amendments to Articles:• Article 40. Production of medicinal products• Article 41. Labelling of medicinal products

Chapter X. Import and export of medicinal products

• The title of chapter is changedAdded new articles: • Article 43. Import of medicinal products• Article 44. Medicinal products allowed for

importation• Article 45. Medicinal products prohibited for

import• Amendments to other articles

Chapter XI. Wholesale and retail sale of medicinal products

• Chapters on wholesale and retail sale are combined• Article 51. Medicinal products prohibited for sale Sales of the following medicinal products are prohibited:• 1) Substandard;• 2) Counterfeit; • 3) Expired;• 4) Dilapidated2. Sale of medicinal products imported into the Kyrgyz Republic for humanitarian purposes is prohibited.3. Sale of medicinal products out of pharmacies is prohibited.

Chapter XII Provision of medicinal product information

• Information on over-the-counter medicines can be published in media, specialized and general newspapers, instructions for use and other publications.

• Information on prescription medicines is allowed only in specialized printed media;

• Any information on safety, quality and efficacy of medicinal products that constitutes the registration dossier is not confidential, except for:

- Personal data of participants of clinical trials;- Production technology;- Methods of testing the medicinal products that represent ownership of the manufacturer or developer;- Information under patent protection.

Chapter XIII. Advertisement of medicinal products. Specifics of medicinal product advertisement

• Regardless of the form, the advertisement should correspond to pharmacological data on the medicine as described in the instructions for medical use

• Medicinal product advertisement must not contain words such as ‘unique’, ‘effective’, ‘safe’.

• Medicinal product advertisement should contain information on the need of use only upon doctor’s prescription.

• It is prohibited to use the image of people in medical uniform.

Chapter XIV. Concluding provisions

Статья 54. Medicinal products as humanitarian aid The following is the basis for provision of humanitarian aid:Основания для оказания гуманитарной помощи• In emergencies, the humanitarian aid can be provided without a

request, provided that the contributions are included in the list of emergency relief items recommended by the United Nations or in the national lists for use in emergency situations.

• Medicinal products received by healthcare organizations as humanitarian aid are subject to accounting and reporting, following the order established by the Government of the Kyrgyz Republic.

• Shelf life of medicinal products intended for humanitarian aid should not be less than 12 months