Thông tư 38/2013/TT-BYT

CIRCULAR

AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF CIRCULAR NO.47/2010/TT-BYT OF DECEMBER 29, 2010 OF THE MINISTER OF HEALTH GUILDING IMPORT AND EXPORT OF MEDICINES AND PACKAGING DIRECTLY CONTACTED WITH MEDICINES

Pursuant to the Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005;

Pursuant to Decree No.63/2012/ND-CP dated August 31, 2012 of the Government providing functions, tasks, power and organizational structure of the Ministry of Health;

Pursuant to Decision No.42/2013/QD-TTg of July 15,2013 of the Prime Minister promulgating the management of medicines for human use via non-trade import or export and the amendment or supplementation of a number of articles of the Regulation on import of medicines which have not registered numbers yet in Vietnam promulgated together with Decision No.151/2007/QD-TTg of September 12, 2007 of the Prime Minister;

At the proposal of Director of the Drug Administration of Vietnam;

The Minister of Health promulgates Circular amending and supplementing a number of articles of Circular No.47/2010/TT-BYT of December 29, 2010 of the Minister of Health guiding import and export of medicines and packaging directly contacted with medicines.

Article 1. Amendment and supplementation of a number of articles of Circular No.47/2010/TT-BYT of December 29, 2010 of the Minister of Health guiding import and export of medicines and packaging directly contacted with medicines (below collectively preferred to Circular No.47/2010/TT-BYT) as follows:

1. Clause 3 of Article 4 is amended as follows:

“3. Requirements for testing slips:

When conducting clearance procedures, enterprises importing medicines or packaging directly contacted with medicines will have to submit the Customs of border gates the original testing slip of manufacturers verifying quality satisfaction for each lot of imported medicines of such manufacturers, except pharmaceutical materials and medicines prescribed in Articles 12, 13, 14, 15, 17 and 18 of this Circular.

In case that 02 or more manufacturers participating in production of medicines, original testing slip of the manufacturer or original testing slip of the final packaging unit or the unit that is responsible for sending out of the factory.

The Customs of border gates will keep copy of testing slips stamped with verification of importing enterprises”.

2. Article 19 is amended as follows:

“Article 19. Materials for medicines and materia medica which have not got registered numbers for circulation, packaging directly contacted with medicines

1. Materials for medicines are permitted to import under List of materials for medicines permitted to import will be announced by the Drug Administration of Vietnam (not requested to have import licenses) in accordance with Clause 2 of this Article or under the form of import license as prescribed in Clause 3 of this Article.

2. Import according to List of materials for medicines permitted to import will be announced by the Drug Administration of Vietnam (not requested to have licenses)

a) List of materials for medicines permitted to import (not required to have licenses) being announced by the Drug Administration of Vietnam will comprise pharmaceutical substances, except materials under the list of narcotic drugs, psychotropic medicines and pre-substances for making medicines. In case that a production unit changes source or quality standards of raw materials, such production unit will have to submit a registration dossier for such changes as prescribed in Annex II which was promulgated together with the Circular No. 22/2009/TT-BYT dated November 24, 2009 by the Minister of Health providing registration of medicines and will only be permitted to import after being agreed by a written consent of the Drug Administration of Vietnam pertaining contents of changes or supplementation.

b) Procedures for announcement

- The Drug Administration of Vietnam will announce the List of materials for production of medicines permitted to import (not required to have licenses) on the website of the Drug Administration of Vietnam (www.dav.gov.vn) according to the prescribed Form No.16 being enclosed with this Circular.

- Within 30 working days, since the date that a medicine is provided with a registration number, the Drug Administration of Vietnam will announce the List of materials for production of medicines permitted to import.

c) Importing enterprises

- Units producing medicines provided with registration numbers will only permitted to import materials in compliance with the List announced.

- Trading enterprises having the function of importing materials for production of medicines will be permitted to import materials under the List of materials permitted to import (not required to have licenses) being announced by the Drug Administration of Vietnam.

d) Import dossiers and procedures

- Production units having demands in import of materials for production of medicines, enterprises importing materials for trade will conduct procedures directly at the Customs of border gates to import materials according to the List announced by the Drug Administration of Vietnam;

- Units producing medicines will have to produce Certificates of eligibility for production of medicines or Certificates of Good Manufacturing Practices for medicines (GMP) in accordance with point c, point d of Clause 1 of Article 3 of this Circular.

- Enterprises importing materials for trading will have to show Certificates of eligibility for trading medicines (under form of wholesales or import, export of medicines) and Certificates of Good Storage Practice (GSP) within their scope of business in compliance with provisions under point a, clause 1 of Article 3 of this Circular.

- The time limit for importing materials for production of medicines under the form of announcement will be equal to the validity time limit of registration numbers of medicines made of such materials.

- Foreign enterprises providing materials for making medicines to Vietnam must have Operating Licenses on medicines and materials for making medicines in Vietnam which are still effective according to provisions under clause 12, Article 3 of this Circular.

3. Import of materials for production of medicines under the form of import license

a) Materials for production of medicines imported under the form of import license will comprise:

- Materials for production of medicines which are not permitted to import under the form of announcement prescribed in clause 2 of this Article;

- Materials under the list of addictive medicines, psychotropic medicines and pre-substances used for making medicines;

- Materials are excipients, capsules, packaging directly contacted with medicines;

- Materials used in researches and testing;

b) Enterprises importing materials under the form of import license and foreign enterprises providing materials for production of medicines to Vietnam prescribed in Article 3 of this Circular.

c) Dossiers for request of issuance of import licenses

- An import order as prescribed Forms No.12a, 12b, 12c, 12d and 12dd being promulgated together with this Circular.

- The List of quality standards and testing methods for raw materials, pharmaceutical materials, packaging directly contacted medicines for raw materials, packaging with quality standards and testing methods of the manufacturer or the photocopied monograph of quality standards of the pharmacopoeia unless otherwise applied by pharmacopoeia of Europe, England, the U.S, Japan or the World.

- For materials for production of medicines which are addictive medicines, psychotropic medicines or pre-substances for production of medicines, it is required to enclose with Inventory Report according to the prescribed Form No.3 which is promulgated together with this Circular.

d) Procedures for issuance of import licenses

Enterprises will send dossiers to the Drug Administration – Ministry of Health. Within 07 working days, since the date of receiving a valid dossier, the Drug Administration – Ministry of Health will consider and issue an import license.

For materials for production of medicines which are addictive medicines, psychotropic medicines and pre-substances, within 15 working days, since the date of receiving a valid dossier, the Drug Administration – Ministry of Health will consider and issue an import license.

In case of refusal, the Drug Administration – Ministry of Health will send a written response to the enterprise and clearly state reasons.

dd) A license for importing materials for production of a medicine which hasn't got a registration number will valid for a maximum of 02 years, since the date of signing."

3. Amend and promulgate additionally the prescribed forms as follows:

a) To promulgate the prescribed Form No.1, enclosed with this Circular in addition to Annex of Circular No.47/2010/TT-BYT (supplemented the prescribed Form No.16).

b) To promulgate the prescribed forms No.2a, 2b, 2c, 2d, 2dd in replacement of prescribed Form No. 12a, 12b, 12c and 12d being enclosed with Circular No.47/2010/TT-BYT.

c) To promulgate the prescribed form No.3 in replacement of prescribed Form No. 1a being enclosed with Circular No.47/2010/TT-BYT.

d) To promulgate the prescribed form No.4 in replacement of prescribed Form No. 3 being enclosed with Circular No.47/2010/TT-BYT.

dd) To promulgate the prescribed form No.5 in replacement of prescribed Form No. 6a being enclosed with Circular No.47/2010/TT-BYT.

e) To promulgate the prescribed form No.6 in replacement of prescribed Form No. 7a being enclosed with Circular No. 47/2010/TT-BYT.

f) To promulgate the prescribed form No.7 in replacement of prescribed Form No.7c being enclosed with Circular No. 47/2010/TT-BYT.

g) To promulgate the prescribed form No.8 in replacement of prescribed Form No. 11a being enclosed with Circular No. 47/2010/TT-BYT.

Article 2. Transitional provisions

1. Dossiers for request of issuance of import licenses for medicines which haven't got registration numbers submitted before January 01, 2014 will be conducted with provisions under Circular No.47/2010/TT-BYT of December 29, 2010 of the Minister of Health guiding the import and export of medicines and packaging directly contacted with medicines.

2. Licenses for import of materials for production of medicines which have not been provided with registration numbers before the effective date of this Circular will be permitted to implement until the expiry date recorded in licenses.

Article 3. Implementation provisions

1. The Drug Administration will notify before December 31, 2014 for all medicines provided with registration numbers before July 01, 2014.

2. From July 01, 2014, the Drug Administration will notify materials under the List of materials permitted to import for production of medicines (not required to have import licenses) within 30 working days, since the date of being provided with registration numbers.

Article 4. Effect

This Circular will take effect on January 01, 2014.

Clause 3 of Article 4, Article 19 of Circular No.47/2010/TT-BYT the prescribed Form No.1a, the prescribed Form No.12a, No.12b, No.12c, No.12d, the prescribed Form No.3, the prescribed Form No.7a, the prescribed Form No.7c and the prescribed Form No.11c which were promulgated together with Circular No.47/2010/TT-BYT will be declared null and void since the effective date of this Circular.

Any problems arising in the course of implementation of this Circular, state agencies, organizations or individuals should report to the Ministry of Health (Drug Administration) in a timely manner for appropriate amendment or supplementation./.

Form No.7

Mẫu số 7

COMMITMENT
BẢN CAM KẾT

To ensure the quality of vaccine and medical biological products
Đảm bảo chất lượng vắc xin, sinh phẩm y tế

Supplier's name/Tên công ty cung cấp:

Address/Địa chỉ:

Telephone number/Điện thoại                                   Fax:                       Telex:

Manufacturer’s name/Tên công ty sản xuất:

Address/Địa chỉ:

We ensure that the following vaccines and medical biological products distributed by our company:

Chúng tôi xin bảo đảm các vắc xin, sinh phẩm y tế sau do chúng tôi cung cấp:

- Produced according to GMP criteria and met with all requirements setting for the quality of vaccines and biological products of local authorities.

Được sản xuất theo tiêu chuẩn GMP, đồng thời đạt các yêu cầu về chất lượng vắc xin, sinh phẩm y tế của cơ quan có thẩm quyền tại nước xuất xứ.

- Curently licensed to be placed on the market for use in the original country and first market authorisation was issued on:

Sản phẩm trên hiện đang được phép lưu hành tại nước xuất xứ và được cấp phép lần đầu vào năm:

We commit ourself to comform to the law and regulation in the field of vaccine and biological products and accept the inspection and examination of Vietnam authorities.

Chúng tôi xin chấp hành các luật lệ và quy định trong lĩnh vực vắc xin, sinh phẩm y tế của nước Cộng hòa xã hội chủ nghĩa Việt Nam và chịu sự thanh tra kiểm tra của cơ quan có thẩm quyền của Việt Nam.

We will bear a responsibilities for the quality of the above vaccines and biological products.

Chúng tôi xin hoàn toàn chịu trách nhiệm trước pháp luật về tiêu chuẩn chất lượng của vắc xin, sinh phẩm y tế trên.