dated on 13 may, 2016 1. list of procedures completion...

1

Attachment for the Notification of the Food and Drug Administration Subject: Period for Providing Public Services B.E. 2559

Dated on 13 May, 2016

1. Procedure according to the Drug Act

List of Procedures Completion

Period 1. One-Day Procedures

1) Issuance of Certificate of Pharmaceutical Product (CPP) and Certificate of Free Sale (CFS).

1 day

2) Request the Certificate of Biologics for veterinary use (in case of having the Certificate of Lot Release from state agencies supervising the transportation according to the given condition).

3) Certify/ approve to import or order the products according to the notification of the Ministry of Commerce.

1 day

1 day

4) Submission for approval of production of drug samples (Phor.Yor 8). except those for research in human.

1 day

5) Submission for approval of import of drug sample for registration (Nor.Yor.8). 1 day 6) Submission for approval of import of traditional drug for registration (Nor.Bor. 8). 1 day 7) Submission for approval of import of drug for analysis (Nor.Yor.Mor.2). 1 day 8) Submission for approval of import of drug for exhibition (Nor.Yor.Mor.3). 9) Submission for approval of import of drug for donation to the public hospital

(Nor.Yor.Mor. 4).

1 day 1 day

10) Amendment to the product license concerning the licensee and overseas

production premises by endorsing the certificate of drug registration (Yor. 4). 11) Amendment to the product license authorized at One Stop Service Center

(OSSC) of the Food and Drug Administration (FDA) according to the notification of the Food and Drug Administration.

1 day

1 day

12) Translation of the Certificate of Drug Registration. 1 day Remark: Condition Item 6 : Only applications submitted at the One Stop Service Center (OSSC) of the Food and Drug Administration (FDA.).

- The period in item 1-12 will be completely considered within 1 day for the application no. 1-30. The application no. 31 and up, will not be completed within one business day.

2. 2-15 Day Working Processes 1) Drug registration in case of transfer. 2) Register the Pharmaceutical Chemicals / Add the Pharmaceuticals/ Chemicals

manufacturer’s name to the database. 3) Submission for approval of production, repacking or import of placebo

5 days 7 days

7 days

2


Period replacement.

4) Issue the replacement of Certificate of Drug Registration. 5) Submission for approval of drug advertisement. 6) Submission for approval of production, import, export or possession for

distribution of category 3 narcotic drugs, category 3 and category 3 or category 4 psychotropic substances.

7) Amendment to the license : - Change or correct the name - surname- of the licensee or entrepreneur or pharmacist or practitioner with the duty to act. - Change the pharmacist or practitioner with the duty to act. - Change the function of the pharmacist with the duty to act (Only manufacturing license of modern drugs). - Change the entrepreneur (Only if the licensee is a legal entity). - Correct the name of the road, sub-district and or premises address without moving out from its original location. - Move or change the place for drug storage / except change or move across the province. - Change the operating hours. - Request the replacement of license. - Change the licensee for manufacturing, sale, import traditional medicine. - Change the licensee in case of transformation into legal entity according to the Civil and Commercial Code and Public Company Limited Act B.E. 2535.

3 days 15 days 10 days

3 days

3 days 3 days

3 days 3 days

3 days

3 days 3 days 30 days 30 days

8) Submission for approval of change the premises manufacturing place in a case of the same premises.

9) Submission for approval of renewal of the license of the drug, category 3 narcotic, category 3 or category 4 psychotropic substances.

10 days

3 days

Remark : Condition Item 5 : 1) Application No. 1-10 per day is guaranteed at 15 days, and each 10 applications shall take extra period of 5 business days, such as filing 30 applications on the same request, the application no. 1-10 will take 15 days, application no. 11-20 will take 20 days for consideration and application no. 21-30 takes 25 days. 2) The aforementioned duration is excluded the technical problems ,dissenting opinion, other issues, or disapproved/ not allowed propose, conduct according to the regulations of the Food and Drug Administration regarding the procedure for permit and comment on advertising the health products B.E. 2541.

3


Period 3) The aforementioned duration is excluded the time spent by the entrepreneur and mailing time of the post office.

- Scope of the term “Technical problem of advertisement permission” such as 1) The drug information claimed did not appear or conform to the registered

drug information. 2) The information was quoted or modified from paper about the quality,

efficiency, efficacy, safety, worthiness or appropriateness.

- The scope of term “Technical problem for consideration of advertisement permit” such as 1) There is no prohibition or rule on the advertising message, but it may be

considered improper / wrong / immoral / illegal. 2) Advertisement/ new advertisement media such as social media which have

never been under consideration before. 3) Message or advertisement which may not be required to apply for the

permission according to the Drug Act B.E. 2510. 4) The information of drug, applicant, or others in the data system are not

appeared or needed modification.

Item 6 : 1) Once the building plan was approved (only for submission for approval of production of modern medicine and traditional medicine), and the premises was inspected.

2) In the case of relocation/changing the location of drug storage, the building plan must be submitted for approval, and the premises must be inspected.

Item 8 : After the premises was inspected.

Item 9 : 1) In case the new license shall not be issued and no any amendment while submission for approval.

2) Such period excludes the time spent by entrepreneur and working hour of post office.

3. Exceeding 15 Days Working Process* 1) Registration of biological medicine, vaccine, for human use. 350 days 2) Registration of new biological medicine (except vaccine for human use). 3) Registration of new veterinary medicine (except biological medicine). 4) Registration of new medicine (except biological medicine). 5) Registration of orphan drug. 6) Registration of medicine that developed from herbal.

320 days 320 days 280 days 200 days 200 days

4


Period 7) Registration of generic biological medicine(except biological medicine which is

vaccine for human use). 8) Registration of traditional medicine. 9) Registration of veterinary medicine by referring in case of changing the premises. 10) Registration of generic medicine and new generic medicine. 11) Registration of veterinary medicine (except biological medicine for animal). 12) Registration of generic medicine and veterinary medicine according to the

criteria of registration of drug using the standard and

160 days

160 days 160 days 155 days 120 days 95 days

analysis method of the active ingredients and finished product according to the

Pharmacopoeia. 13) Registration of traditional medicine which is single herbal medicine or balm

recipe in case the formulation has already been registered. 14) Registration of veterinary medicine by referring in case of original premises. 15) Registration of drug manufacturing for export. 16) Amendment to the biological drug registration of vaccine for human use.

17) Amendment to the modern drug registration being submitted to specialist for

consideration. 18) Amendment to the traditional medicine and herbal medicine registration being

submitted to specialist for consideration. 19) Amendment to the modern drug registration considered by an authority (except

biological medicine which is vaccine for human use). 20) Amendment to the traditional medicine and herbal medicine considered by an

authority. 21) Submission for approval of importing drug for clinical trial in case of biological

medicine (Nor.Yor.Mor. 1). 22) Submission for approval of importing drug for clinical trial in case of human use

except biological medicine (Nor.Yor.Mor. 1). 23) Submission for approval of importing drug for donation to charity in the case of

a private hospital (Nor.Yor.Mor. 4). 24) Submission for approval of ending Safety Monitoring Program. 25) Submission for approval of the bioequivalence report. 26) Submission for approval of the Therapeutic Equivalence Protocol. 27) Submission the request for the certificate of lot release of biological veterinary

products. 28) Submission for approval of drug advertisement to the medical practitioner. 29) Issue the Certificate of manufacturing standard for registration of drug imported. 30) Submission for approval of the plan of the medicine and traditional medicine

80 days


160 days

160 days

60 days

60 days

60 days

20 days

30 days

160 days 155 days 140 days 20 days


5


Period manufacturing premises.

31) Inspection the premises for the purpose of issuing the license for production, selling, or importing the drug, category 3 narcotic ,and category 1 or category 4 psychotropic substances.

Remarks : Condition

20 days

*1) Duration means the time including that the specialist / sub-committee spend to consider just one round only. 2) Such duration excludes time that entrepreneurs request for waiver the amendment or submit additional documents or change the specialist during consideration. 3.) Excluding the case that propose to Drug Committee and the consideration of appeals on modern drugs / traditional medicine and herbal medicine. 4) In the event that the entrepreneur request the exemption from the amendment or provision additional information. It shall comply according to the specified period stipulated in the notification of Drugs Bureau. If it is not done within the specified period. The Drug Bureau will not take into consideration. Item 28: : Submission for approval of the advertisement to medical practitioner 1) For the application submitted is not more than 4 pages and / or technical paper

for consideration is not more than 4 items (the guarantee time is for application 1-4, the consideration time will be increased 10 business days for each 4 applications for example 12 applications are submitted on the same day, the first application no. 1-4 will take 30 days, application no. 5-8 will takes 40 days, and application no. 9-12 will takes 50 days)

2) This procedure excludes the time used in case of technical problem, academic problems or having dissenting opinion or any other issues or unapproved following to the regulations of the Food and Drug Administration regard the procedure for permission and giving comment on advertising health products B.E. 2541.

3) The aforementioned duration is excluded the time spent by the entrepreneur and mailing time of the post office.

-Scope of the term “Technical problem of advertisement permission” such as 1) The drug information claimed did not appear or conform to the registered drug information.

2) The information was quoted or modified from paper about the quality, efficiency, efficacy, safety, worthiness or appropriateness.

- The scope of term “Technical problem for consideration of advertisement permit” such as 1) There is no prohibition or rule on the advertising message, but it may be

6


Period considered improper / wrong / immoral / illegal.

2) Advertisement/ new advertisement media such as social media which have never been under consideration before.

3) Message or advertisement which may not be required to apply for the permission according to the Drug Act B.E. 2510.

4) The information of drug, applicant, or others in the data system are not appeared or needed modification.

Item 30 : Asking for approval the layout of modern or traditional pharmaceutical manufacturing facility : 1 round per consideration.

2. Legal Procedure concerning Food

List of Procedure Completion

Period 1. One-Day Procedure

1) Application for food registration/ food notification (Sor.Bor. 5) for quality or standard controlled food, food required labeling, and processed food in containers available for sale (Application No. 1-100, the product are both manufactured and imported from the GMP certified premises).

2) Application for amendment to the product license/ food notification (Sor.Bor. 6) for quality or standard controlled food, food required labelling and processed food in containers available for sale (Application No. 1-100).

3) Request a copy (Only information that is kept at the Food and Drug Administration) (Application no. 1-10). - Application for serial number of the premises that are not recognized as

factory. - Application for change of the premises that are not recognized as factory. - Application for approval of food labels. - Application for amendment to the approved label. - Application for food registration/food notification. - Application for amendment of the product license/food notification.

4) Application for the replacement of food manufacturing license (Aor. 4) (Application no. 1-5) (Only information kept at the Food and Drug Administration)

5) Application for the replacement of import license (Aor. 9) (Application no. 1-5) (Only the information kept at the Food and Drug Administration).

6) Application for the replacement of the product license (Aor.20) (Application no. 1-5) (Only the information kept at the Food and Drug Administration)

1 day

1 day

1 day

1 day

1 day

1 day

7


Period 7) Application for renewal license for food manufacturing (Aor.3) (which has been

assessed the manufacturing facility to GMP standard) (Application no. 1-12) (Only the data kept at the Food and Drug Administration).

8) Application for renewal import license (Aor. 8) (Application no. 1-12) (Only the data kept at the Food and Drug Administration).

9) Application for amending the list in food manufacturing license (Sor.4) (Application no. 1-5) (Only the data kept at the Food and Drug Administration).

10) Application for amendment to the import license (Sor.5) (Application no. 1-5) (Only the data kept at the Food and Drug Administration) on the following details: - Change of the name of licensee (in case of juristic person) including change

the status to public company limited. - Change of the name/surname or change of the operator in case of juristic

person. - Change of the name/surname of licensee (in case of natural person). - Change of the address (not relocation) of the permitted premises. - Modification of the category of the permitted food.

11) Application for change of the food manufacturing facility which premises are not recognized as factory (Sor.Bor. 2) (Application no. 1-5) (Only the data kept at the Food and Drug Administration) for the items revision detailed below. - Change of the name of licensee (in case of juristic person) including change

of the status to be public company limited. - Change of the name/surname or change of the entrepreneur in case of

juristic person. - Change of the name/surname of licensee (in case of natural person). - Change of the address (not relocation) of the permitted premises. - Modification of the category of the permitted food.

1 day

1 day

1 day

1 day

1 day

2. 2-15 Days Working Process 1) Application for food registration/ food notification (Sor.Bor. 5) especially for: 1.1) Application for food registration/ food notification (Sor.Bor. 5) for quality or

standard controlled food, food required labelling and processed food in containers available for sale (Application No. 1-100).

1.2) Application for amendment to the registered food / (Sor.Bor. 6) for determining food quality or standards, food required labelling and processed food in containers available for sale (After Application No. 100 onward).

2 days

2 days

8


Period 1.3) Application for food registration (Sor.Bor.5) for quality or standard controlled

food, i.e. food supplement (export only). 10 days

2) Request a copy (after application no. 10 onward) (only information that is kept

at the Food and Drug Administration). 2 days

- Application for serial number of the premises that are not recognized as factory.

- Application for change of the premises that are not recognized as factory. - Application for approval of food labels. - Application for amendment to the approved label. - Application for food registration/food notification. - Application for amendment of the product license/food notification.

3) Application for renewal manufacturing license (Aor. 3) in case no plant inspection required/the manufacturing facilities being inspected according to GMP (after application no. 12 onward).

5 days

4) Application for the replacement of food manufacturing license (Aor. 4) (after Application no. 5 onward).

5 days

5) Application for import license (Aor. 6) 6) Application for renewal import license (Aor. 8) (after Application no. 12

onward). 7) Application for the replacement of import license (Aor. 9) (after Application no.

5 onward). 8) Application for approval of relocation of import premises or storage premises

(Aor. 10). 9) Application for occasionally food manufacturing license (Aor. 11). 10) Application for amendment to the manufacturing license (Sor. 4) (after

application no. 5 onward) in case no plant inspection required, only the list stated as follows: - Change of the name of licensee (in case of juristic person) including change

of the status to public company limited. - Change of the name/surname or change of the entrepreneur in case of


7 days 5 days

5 days

7 days

15 days 7 days

11) Application for amendment to the import license (Sor.5) (after application no. 5 onward) only the list stated as follows: - Change of the name of licensee (in case of juristic person) including change

of the status to public company limited.

7 days

9


Period - Change of the name/surname or change of the entrepreneur in case of


12) Application for amendment to the product license (Aor. 19) only the list stated as follows :

7 days

- Change of the name of licensee (in case of juristic person) including change of the status to public company limited.

- Change of the name/surname or change the entrepreneur in case of juristic person.

- Change of the name/surname of licensee (in case of natural person). - Change of the address (not relocation) of permitted premises. - Modification of the food labelling according to the Appendix 4 of the

regulation of Food and Drug Administration : Operational Procedures on Food Serial Numbers B.E.2557.

13) Application for amendment to the label approved food (Sor. Bor. 4) only the list stated as follows:

7 days


- Change of the name/surname or change the entrepreneur in case of juristic person.

- Change of the name/surname of licensee (in case of natural person). - Change of the address (not relocation) of permitted premises. - Modification of the food labelling according to the Appendix 4 of the

regulation of Food and Drug Administration : Operational Procedures on Food Serial Numbers B.E.2557.

14) Application for modification of the food manufacturing premises not recognized as factory (Sor Bor 2) (after application no. 5 onward) and in case of no plant inspection required only the following details :

7 days


- Change of the name/surname or change of the entrepreneur in case of juristic person.

- Change of the name/surname of licensee (in case of natural person). - Change of the address (not relocation) of the permitted premises.

10


Period - Modification of the category of the permitted food.

15) Application for replacement of product license (Aor. 20) (after application no. 5 onward).

16) Clarification letter for the request of moreover Labels for food manufactured for export.

17) Certification of manufacturing premises or product (for export) in case of permission information existed.

18) Application for food advertisement (not included the advertisement with claim which need assessed by the export).

19) Application for food registration (Sor Bor. 5) for quality standard controlled food i.e. milk, flavored milk, milk products, yogurt, ice cream, drinks in sealed containers and food in hermetically sealed containers (According to the conditions in the Food and Drug Administration Declaration, on Guidelines on application for approval of food under the to reprocessed system.), and depending on the complexity of the formula.

5 days

3 days

5 days

10 days

7-15 days

3. Exceeding 15 Days Working Process 1) Application for establishment of food premises (Aor.1) (excluding the time for

modification of production facilities and unavailability of the entrepreneur). - Premises in Bangkok. - Premises in the provinces.

20 days 60 days

2) Application for relocation of production premises or storage premises (Aor. 5) (excluding the time for modification of production facilities and unavailability of the entrepreneur).

- Premises in Bangkok. - Premises in the provinces.

35 days 60 days

3) Application for amendment of the lists in food manufacturing license (Sor.4) (in the case of inspection of production facilities) (excluding the time for modification of production facilities and unavailability of the entrepreneur).


4) Application for renewal food manufacturing license (Aor.3) (in the case of inspection of production facility) (excluding the time for modification of production facilities and unavailability of the entrepreneur).


5) Application for food serial number of manufacturing which premise are not recognized as factory (Sor.Bor.1) (in the case of inspection the production

11


Period facility according to GMP) (excluding the time for modification of production facilities and unavailability of the entrepreneur).


6) Application for modification of the production facility which premise are not recognized as factory (Sor.Bor.2) (in the case of inspection the production facility according to GMP) (excluding the time for modification of production facilities and unavailability of the entrepreneur).


7) Application for food registration (Sor. Bor. 5) for quality standards controlled food i.e. milk, flavored milk, milk products, yogurt, ice cream, drinks hermetically in sealed containers and food in hermetically sealed containers. If the conditions are not under the criteria of the Food and Drug Administration Declaration, on Guidelines on application for approval of food under to the reprocessed system, mineral drink and coffee according to the attached as Appendix 3 of the regulation of Food and Drug Administration, on Operational Procedures on Food Serial Numbers B.E.2557 and depending on the complexity of the formula.

8) Application for amendment of the details in food registration (Sor.Bor.6) for quality and standard controlled food i.e. milk, flavored milk, milk products, yogurt, ice cream, drinks in hermetically sealed containers and food in hermetically sealed containers. If the conditions are not under the criteria the Food and Drug Administration Declaration, on Guidelines on application for approval of food under the reprocesses system, mineral drink and coffee according to the attached as Appendix 3 of the regulation of Food and Drug Administration, on Operational Procedures on Food Serial Numbers B.E.2557 and depending on the complexity of the formula.

9) Application for product license (Aor.17) for the specific controlled food, of 100% food additives.

10) Application for product license (Aor.17) for the specific controlled food other than 100% food additives (duration depending on the complexity of the formula in the product).

11) Application for amending the product license (Aor.19) for the specific controlled food, of 100% food additives.

20 days 60 days

35 days 60 days

20-35 days

20-35 days

24 days

35-90 days

17 days

12


Period 12) Application for amendment to the product license (Aor.19) for the specific

controlled food in case the amendment affects the name of food, ingredient, manufacturing process, quality, standard, benefit ( except the application to be assessed by the working group or expert).

13) Application for food labelling (Sor.Bor.3) for specific controlled food, of 100% food additive.

14) Application for food labelling (AorBor.3) for specific controlled food other than 100% food additives (duration depending on the complexity of the formula in the product).

15) Application for amendment to the label approved food (Sor.Bor.4) for specific controlled food, of 100% food additive.

25 days

24 days

35-90 days

17 days

16) Application for amendment to the label approved food (Sor.Bor.4) for specific controlled food, of 100% food additive. In case the amendment affects the name of food, ingredient, manufacturing process, quality standard, benefit ( except the application to be assessed by the working group or expert).

17) Application for food registration (Sor.Bor.5) for quality and standard controlled food, in case of food supplement under following criteria: Criteria 1 : The products with principal ingredient in accordance with the list set by Food and Drug Administration or Criteria 2 : The products with all ingredients; in accordance with the product license (copy of the product license needed).

18) Application letter for approval of food formula and the use of food additives. 19) Application letter enquiring about food in case :

- In accordance with the notification of the Ministry of Public Health. - Not in accordance with the notification of the Ministry of Health.

20) Application letter for consideration of quality or standard of products (excluding food additive not listed in the notification regarding food additives).

21) Application letter for approval of food formula and the use of food additives (excluding cases where the use of food additives in addition to the notification (281) prescribed / components which are not normally consumed as food).

25 days

25 days

25 days

30 days


30 days

4. Law Procedure regarding the Medical Device


Period 1. One-Day Procedure 1) Application for certificate of import of Medical Device.

1 day

13


Period 2) Application for additional medical devices in the certificate of import. In case there is one medical device. 3) Application for certificate of export of Medical Device. 2. 2-15 Days Working Process 1) Application for certificate of import of Medical Device.

1.1) Medical devices more than one item but not more than 100 entries. 1.2) Medical devices more than 100 entries. 1.3) Request of additional items of medical device in the certificate of import, in case medical device has more than one item. 1.4) Request of other amendment to the certificate of import. 1.5) Request of the replacement of the certificate of import

1 day

1 day


3 days 3 days

2) Application for importation of medical devices that are exempted from certificate of import.

2.1) import of medical devices that are used as components, accessories or spare parts in the production of medical devices or medicine by the licensee in the country which exempted by the notification of the Ministry of Health (No. 34), B.E. 2549.

2.2) Import of medical devices for the production for export which exempted by the notification of the Ministry of Health (No. 34), B.E. 2549.

2.3) Import of medical devices for clinical research which exempted by the notification of the Ministry of Health (No. 34), B.E. 2549. 2.4) Import of medical devices for research, analysis, or testing of quality or standards which exempted by the notification of the Ministry of Health (No. 34), B.E. 2549.

2.5) Import of medical devices for donation to government agencies responsible for prevention, investigation, treatment, or rehabilitation or to the Red Cross or another charity organization approved by the Food and Drug Administration which exempted by the notification of the Ministry of Health (No. 34), B.E. 2549. 3) Application for production and import of medical devices according to the

Medical Devices Act B.E. 2551. 3.1) Application for amendment to the production license and import licenses

according to the Medical Device Act B.E. 2551, in case not submitted to an expert, working group, or subcommittee. 3.2) Application for the replacement of production license and import license.

3.3) Renewal of the production license and import licenses, according to the Medical Device Act B.E. 2551.

4) Request for notification of production and import of medical devices According

4 days

4 days

4 days

4 days

4 days

5 days

4 days 4 days

14


Period to the Medical Devices Act B.E. 2551.

4.1) The application for amendment to the certificate of notification of production and receipt of notification of import according to the Medical Devices Act B.E. 2551 in case not submitted to an expert, working group, or subcommittee. 4.2) The application for replacement of certificate of notification of production and import. 4.3) The renewal of certificate of notification of production and certificate of notification of import according to the Medical Devices Act B.E. 2551.

4 days

4 days 4 days

Remark: Condition Items 3.3 and 4.3 are not include the application for renewal of the license to produce and import, the certificate of notification of production and import issued before the ministerial regulation of permission to produce or import medical device, notification of details of production or import B.E. 2555 which required additional technical evidence about the safety of the relevant medical devices, according to the ASEAN Agreement on Medical Device Directive (AMDD) which required the consideration before being permitted to renew. Such evidence contains details, technical complexity and many technology documents which needed longer time to investigate than the scheduled time. 5) Production or import of medical devices which exempted from obtaining a permit or a certificate of notification.

5.1) Production or importation of medical devices in quantities enough for exhibition or study or research studies, which are exempted from having to obtain a license or certificate of notification in case of not submitted to the expert, working group or subcommittee.

5.2) Production or importation of medical devices in quantities enough for sample to apply for permission or notification which are exempted from having to obtain a license or certificate of notification in case of not submitted to the expert, working group or subcommittee.

4 days

4 days

5.3) Production of medical devices in quantities enough for sample to export which are exempted from having to obtain a license or certificate of notification in case of not submitted to the expert , working group or subcommittee.

4 days

6) Application for the production of medical devices for export under section 34 of

15


Period the Medical Devices Act B.E. 2551. 6.1) Application for the production of medical devices for export under section

34 of the Medical Devices Act B.E. 2551. 6.2) Application for amendment to the Certificate of production of medical

devices for export under section 34 of the Medical Devices Act B.E. 2551. 6.3) Application for the replacement of the license of production of medical

devices for export under section 34 of the Medical Devices Act B.E. 2551.

5 days

5 days

5 days

7) Application for the permission of medical devices distribution. 7.1) Application for permission of the distribution of medical devices in Bangkok area. 7.2) Application amendment to the license for distribution of medical devices. 7.3) Application for the replacement of the license for distribution of medical devices. 7.4) Application for renewal of the license for distribution of medical devices. 7.5) Application for relocation or change the premise for distribution or storage of medical devices in Bangkok and vicinity.

15 days

5 days 4 days

4 days

10 days

8) Application for permission of advertisement. 8.1) Application for permission, in case of not submitted to experts, working group or Subcommittee. 8.2) Application for amendment to the license of medical device advertisement. 8.3) Application for the replacement of the license of medical device advertisement.

9) Application for identification of medical devices in case of not submitted to the expert, working group or subcommittee.

10 days

5 days 4 days

10 days

10) Application for registration of establishments for production or import of medical devices

10.1) Application for registration of import establishment in case of no inspection of premises

15 days

10.2) Application for relocation/ changing import establishment or storage establishment in case of no inspection of premises. 10.3) Application for amendment the certificate of establishments for production or import of medical devices in case no inspection of premise. 10.4) Application for the replacement of the certificate of establishment for production or import of medical devices. 10.5) Application for renewal of the certificate of establishment for production or import of medical devices.

13 days

5 days

4 days

4 days

16


Period 3. Exceeding 15 Days Working Process 1) Production or import of medical devices which are exempted from obtaining a

permit or request a certificate of notification. 1.1) Production or importation of medical devices in quantities enough for

exhibition or study or research studies, which are exempted from having to obtain a license or certificate of notification in case of not submitted to the expert , working group or subcommittee.

1.2) Production or importation of medical devices in quantities enough for sample to apply for permission or notification which are exempted from having to obtain a license or certificate of notification in case of not submitted to the expert , working group or subcommittee.

1.3) Production of medical devices in quantities enough for sample to export which are exempted from having to obtain a license or certificate of notification in case of not submitted to the expert , working group or subcommittee.

2) Application for the production and import of medical devices under section 34 of the Medical Devices Act B.E. 2551.

20 days

20 days

20 days

2.1) Application for the production and import of medical devices under Medical Devices Act B.E. 2551 in case of not submitted the expert, working group or subcommittee.

2.2) Application for the production and import of medical devices under Medical Devices Act B.E. 2551 in case of submitting the expert, working group or subcommittee.

2.3) Application for amendment of the entries permitted in the license of production and import license of medical devices under Medical Devices Act B.E. 2551.

2.4) Application for production and import of medical devices under Medical Devices Act B.E. 2551 in case of new medical devices.

3) Application for notification of production and import of medical devices according to the Medical Devices Act B.E. 2551.

40 days*

90 days*

35 days*

250 days

3.1) Application for notification of production and import of medical devices under Medical Devices Act B.E. 2551 in case of not submitted the expert, working group or subcommittee.

3.2) Application for notification of production and import of medical devices under Medical Devices Act B.E. 2551 in case of submitting to the expert, working group or subcommittee.

3.3) Application for amendment of notification of production and import of medical devices under Medical Devices Act B.E. 2551 in case of submitting

40 days*

90 days*

35 days*

17


Period to the expert, working group or subcommittee.

3.4) Application for notification of production and import of medical devices under Medical Devices Act B.E. 2551 in case of new medical devices.

4) Application for advertisement of medical devices in case of submitting the expert, working group or subcommittee.

5) Application for identification of medical devices in case of submitting the expert, working group or subcommittee.

6) Application for registration of establishment for production or import of medical devices.

250 days

30 days*

90 days*

6.1) Application for registration of establishment for production or import of medical devices.

- In case of inspection of premises in Bangkok and vicinities. - In case of inspection of premises in the province.

30 days 40 days

6.2) Application for relocation/changing the establishment for production or import or storage of medical devices.

- In case of inspection of premises in Bangkok and vicinities. - In case of inspection of premises in the province.

28 days 38 days

6.3) Application of amendment to the certificate of establishment of medical device production (in case of change/additional scope). - In case of inspection of premises in Bangkok and vicinities. - In case of inspection of premises in the province.

23 days 33 days

Condition - Completion Period means the time expert and working group use for consideration of the application only one round. - Completion Period excludes the time for the service fee payment, correction of the documents, sending and receiving documents, or changing the expert during the consideration. - Not include the time by subcommittees, committee or the additional experts in case of the consideration problem. - Depending on the duration of normal electronic data recording system and sufficient number of authorities who can perform at that time.

* Refers to the case of high risk medical devices which required consideration by the specific experts. This may take several branches of expert to consider the safety of the physical properties and various clinical indications. For this reason, the duration of the assessment by experts or working groups, or subcommittee for high risk

18


Period medical devices shall take a longer time than the specified period and sometimes cannot determine the exact time of completion.

4. Procedure under the narcotic law and psychotropic substance

List of Procedure Completion Period1.One-Day Procedure 1) The renewal of a license for possession or use of the psychotropic substances 2) The renewal of the license for distribution or possession of schedule 2 narcotic 3) Notification of import of schedule 2 and 3 psychotropic substances. 4) Notification of export of schedule 2 and 3 psychotropic substances.

2 hours 30 minutes 2 hours 30 minutes

4 hours 4 hours

2. 2-15 Days Working Process 1) Application for a license for possession or use of psychotropic substances for use in hospitals. (In case of private hospitals) 2) Application for a license for possession or use of psychotropic substances for use in hospitals. (For non-private hospitals)

3 days

3 days

3) Application for a license for possession or use of psychotropic substances for the purpose of supplying psychotropic substances, category 2. 4) Application for a license for possession or use of psychotropic substances for scientific use. (in case of government agencies)

5) Application for a license for possession or use of psychotropic substances for scientific use. (in case of private sector)

6) Application for a license for permission or use of psychotropic substances to produce the preparation.

3 days

3 days

3 days

3 days

7) Application for license for distribution the schedule 2 type A narcotic (for public hospitals / government agencies).

8) Application for license for distribution of the schedule 2 type C narcotic (for private hospitals).

9) Application for license for possession of schedule 2 type A narcotic (for Government agencies).

10) Application for license for possession of schedule 2 type C narcotic (for private agencies).

11) Application for the replacement of the license for distribution or possession of schedule 2 narcotic.

12) Application for the replacement of the license for possession or use of

3 days

3 days

3 days

3 days

2 days

2 days

19

List of Procedure Completion Periodpsychotropic substances.

13) Application for the license for distribution or possession of schedule 2 narcotic the quantity prescribed in Section 8 (5).

14) Application for the import license of schedule 4 narcotic (temporary Acetic anhydride). 15) Application for Certificate to import of caffeine. 16) Application for occasionally import of the schedule 1,2 psychotropic

substances. 17) Application for occasionally export of the schedule 1,2 psychotropic substances. 18) Application for occasionally import of the schedule 3,4 psychotropic

substances. 19) Application for occasionally import of the schedule 2 narcotic. 20) Application for occasionally export of the schedule 2 narcotic. 21) Application for occasionally import of the schedule 3 narcotic. 22) Application for occasionally export of the schedule 3 narcotic. 23) Application for Certificate to import of the schedule 4 narcotic. 24) Application for production or import of the schedule 2 or 4 psychotropic

substance sample. 25) Application for amendment to the product license (in case of not submit to external expert). 26) Application for amendment to the schedule 3 narcotic license (in case of not

submit to external expert). 27) Application for narcotic advertisement. 28) Application for import of the schedule 2 narcotic, in case the patient take into the Kingdom. 29) Application for export of the schedule 2 narcotic, in case the patient take out of the Kingdom.

7 days 4 hours

3 days 1 hours

11 days

3 days 1 hours

3 days 1 hours 3 days 1 hours

3 days 1 hours 3 days 1 hours 3 days 1 hours 3 days 1 hours 3 days 1 hours

14 days

8 days

8 days

13 days 3 days

3 days

3. Exceeding 15 Days Working Process 1) Application for annually import of the schedule 3 narcotic, containing Codeine as

ingredient. 2) Application for Codeine possession, for use in the production of schedule 3

narcotics for domestic distribution and / or for export, annually. 3) Application for import of the schedule 3 narcotic containing Codeine as

ingredient, during the year. 4) Application for Codeine possession, for use in the production of schedule 3

narcotics for domestic distribution and / or for export, during the year. 5) Application for product license (in case of new drug). 6) Application for registration of schedule 3 narcotic substance (in case

50 days

50 days

55 days

55 days

210 days 210 days

20

List of Procedure Completion Period of new drug). 7) Application for product license (in case of non- new drug). 8) Application for registration of schedule 3 narcotic substance (in case of non-new drug). 9) Renewal of the certificate of product license. 10) Renewal of the certificate of schedule 3 narcotic license. 11) Application for amendment to the product license (in the case of submitting to external expert).

160 days 141 days


12) Application for amendment to the schedule 3 narcotic license (in the case of

submitting to external expert). 13) Application for possession of schedule 4 narcotic (in case of Acetic anhydride by

the industry processing under the close system, only for news establishment). 14) Application for possession of schedule 4 narcotic (in the case of existed one,

request as the continuation). 15) Application for possession of schedule 4 narcotic (in the case of industry not-

under a closed system, new establishment). 16) Application for possession of schedule 4 narcotic (in the case of scientific

purpose, new establishment). 17) Application for possession of schedule 4 narcotic, addition of quantity during

the year/addition of type during the year. 18) Application for production to distribute, import, export or possession of

schedule 5 narcotic (except for Hemp).

80 days

102 days

78 days

102 days

102 days

78 days

75 days

5. Procedure under the law regarding the cosmetic


Period 1. One-Day Procedure

1) Application for certificate of distribution, origin of the production, manufacturer, the certificate of Bovine Spongiform Enchephalopathy free. 2) Application for certificate of distribution, origin of the production, manufacturer, via the computer network of the Food and Drug Administration. 3) Application for copy of the GMP certificate. 4) Notification for changing name or location of the production, import or storage premises of controlled cosmetics. 5) Application for the license to occasionally import finished cosmetic products. 6) Cancellation of the license or certificate. 7) Application for seal on the power of attorney, identification of cosmetics entrepreneur.

1 day

1 day

1 day 1 day

1 day 1 day

3 hours

21


Period 2. 2-15 Days Working Process

1) Identification of cosmetics category. 2) Request of comment on the labeling of cosmetics. 3) Application for notification of controlled cosmetics, produced or imported for distribution. 4) Application for notification of controlled cosmetics, produced or imported for distribution via the computer network of the Food and Drug Administration. 3. Exceeding 15 Days Working Process

1) Request of comments on cosmetics advertisement.


3 days

20 days

6. Procedure according to the law on hazardous substances.


Period 1. One-Day Procedure 1) Notification of type 1 hazardous substance, and amendment to the certificate of notification of type 1 hazardous substance. 2) Application for replacement of the certificate of notification of type 1 hazardous substance. 3) Renewal of the certificate of notification to produce, import, export or possession of type 2 hazardous substance, in case of not issue a new certificate. 4) Renewal of the license to produce, import, export or possession of the type 3 hazardous substance, in case of not issue a new certificate. 5) Application for Certificate of Product Registration. 6) Application for Certificate of Free Sale. 7) Application for Certificate of Manufacture. 8) Certify a copy of Certificate of Manufacture.

3 hours

3 hours

3 hours

3 hours

1 day 1 day 1 day 1 day

2. 2-15 Days Working Process

22


Period 1) Notification of production, import, export or possession of type 2 hazardous substance. 1.1) Notification of the production, import, export or possession of type 2 hazardous substance, at One Stop Service Center.

1.2) Notification of production, import, export or possession of type 2 hazardous substances, via the computer network of the Food and Drug Administration.

2 days

2 days

2) Application for amendment to the certificate of notification of production, import, export or possession of type 2 hazardous substances.

3) Renewal of the certification of notification of production, import, export or possession of type 2 hazardous substance, in the case of issuance of new certificate.

3.1) Renewal of certification of notification of production, import, export or possession of type 2 hazardous substances, in case the new certificate is issued and submitted at one stop service center.

3.2) Renewal of certification of notification of production, import, export or possession of type 2 hazardous substances, in case the new certificate is issued and submitted via the computer network of the Food and Drug Administration.

2 days

2 days

2 days

4) Application for replacement of the certificate of notification of production, import, export or possession of type 2 hazardous substances.

5) Application for replacement of the product license. 6) Application for replacement of the license to produce, import, export or

possession of type 3 hazardous substances. 7) Application for certificatation of a copy of document for submission for registration,

permission, or notification to regarding the hazardous substance. 8) Application for permission of import or production of the sample. 9) Application for amendment to the product license. 10) Application for amendment to the License for production, import, export or

possession of type 3 hazardous substances, in the case of no inspection of premises. 11) Application for the Certification of document in English such as the product

license. 12) Application for obtaining the rights to submit the application through the computer network of the Food and Drug Administration (ID + PASSWORD). 13) Identification of products, in case of complete information in accordance with the

criteria and not overlap with other products. 14) Renewal of product license. 15) Renewal of the license to produce, import, export or possession of type 3

hazardous substance, in the case of issuance of new license. 15.1) Renewal of the license to produce, import, export or possession of type 3

2 days

3 days 3 days

3 days


4 days

4.5 days

4.5 days

5 days

5 days

23


Period hazardous substance, in case the new license is

issued and submitted at one stop service center. 15.2) Renewal of the license to produce, import, export or possession of type 3

hazardous substance, in case the new license is issued and submitted through the computer network of the Food and Drug

Administration. 16) Application for export of the type 3 hazardous substance, in case the storage

premises has been approved. 17) Application for produce or import of type 3 hazardous substance, in case the

existing production line or storage premises have been approved. 18) Application for Certificate of Free Sale in case of trade name different from the

registered or need issuance of attachments. 19) Request for licensing information or others regarding the hazardous substances

which shall be reworked. 20) Application for import of the type 3 hazardous substance, in the case of the new

storage premises. 21) Application for export of the type 3 hazardous substance, in the case of

the new storage premises. 22) Application for amendment to the import license of type 3 hazardous substance,

in the case of inspection of premises. 23) Application for amendment to the export license of type 3 hazardous substance,

in the case of inspection of premises.

3. Exceeding 15 Days Working Process 1) Application for possession of type 3 hazardous substances. 2) Application for amendment to in the license of possession of type 3 hazardous

substances, in case of inspection of the premises. 3) Application for amendment to the license of production of type 3 hazardous

substances, in case of inspection of the premises. 4) Application for amendment to the product license that is subject to the terms and

conditions notified by Bureau of Cosmetic and Hazardous Substances Control. 5) Application for production of type 3 hazardous substance, in case of new

production premises or new production line. 6) Application for registration of, Pesticides product, in case the applicant has already

registered but change the trade name. 7) Application for registration of, disinfectant and bleaching product, in case the

applicant has already registered but change the trade name. 8) Application for registration of, cleaning and correction product, in case the

5 days

5 days

7 days

7 days

15 days

15 days

15 days

15 days

15 days

17 days 17 days

20 days

20 days

21 days

30 days

30 days

30 days

24


Period applicant has already registered but change the trade name.

9) Identification of hazardous substances if the information is not fully in accordance with the criteria/in the case of proposing to the Working Group

10) Registration of the, pesticides product in case the raw material of technical grade

has been registered. 11) Application for amendment to the product license that do not comply with the

conditions notified by Bureau of Cosmetic and Hazardous Substances Control. 12) Registration of, pesticides product in case the substance has been registered. 13) Registration of, disinfectant and bleaching products, in case the substance has

been registered. 14) Registration of, cleaning and correction products, in case the substance has been

registered. 15) Registration of, pesticides product in case the substance has not been registered

(new substance). 16) Registration of disinfectant and bleaching products in case the substance has not

been registered (new substance). 17) Registration of, cleaning and correction products in case the substance has not

been registered (new substance).

35 days

45 days

50 days

75 days 75 days

75 days

120 days

120 days

120 days

7. Import Process into the Kingdom regarding the Health Product


Period 1. One-Day Procedure 1) Consideration of import of health products at Food and Drug Administration Checkpoint. 2) Application for Permission of occasionally import of the food (for import does not exceed 20 items).

8 minutes per 1 item

2 hours 30 minutes

8. Procedure to Diagnose the Category of Health Product


Period 1. Exceeding 15 Days Working Process 1) Identification of health product which has overlap issues (in the case of proposing to the working group 1 time).

52 days

-------------------------------------------------------------------

dated on 13 may, 2016 1. list of procedures completion...

Documents