Quyết định 99/2007/QĐ-BNN ngày 03/12/2007 sửa đổi Quyết định 10/2006/QĐ-BNN quy định thủ tục đăng ký sản xuất, nhập khẩu, lưu hành thuốc thú y, nguyên liệu làm thuốc thú y, chế phẩm sinh học, vi sinh vật, hóa chất dong trong thú y do Bộ trưởng Bộ Nông nghiệp và Phát triển nông thôn ban hành

DECISION

ON AMENDMENTS TO THE DECISION NO. 10/2006/QD-BNN DATED FEBRUARY 10, 2006 OF THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT ON PROCEDURES FOR REGISTRATION OF MANUFACTURING, IMPORT, AND SALE OF VETERINARY DRUG, VETERINARY DRUG INGREDIENTS, BIOPRODUCTS, MICROORGANISMS, AND CHEMICALS IN VETERINARY DRUGS

MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Government's Decree No. 86/2003/ND-CP dated July 18, 2003 defining functions, tasks, entitlements, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Law on Promulgation of legislative documents dated November 12, 1996; the Law on amendments to some Articles of the Law on Promulgation of legislative documents dated December 16, 2002;

Pursuant to the Ordinance on Veterinary Medicine dated April 29, 2004 and the Government's Decree No. 33/2005/ND-CP dated March 15, 2005 detailing the Ordinance on Veterinary Medicine;

At the request of the Director of the Department of Animal Health,

DECIDES:

Article 1. Article 3, Article 5, Clause 1 Article 8, Point f Clause 1 and Clause 4 Article 8, Point b Clause 2 Article 14 of the Regulation on procedures for registration of manufacturing, import, and sale of veterinary drugs, veterinary drug ingredients, bioproducts, microorganisms, and chemicals in veterinary drugs promulgated together with the Decision No. 10/2006/QD-BNN dated February 10, 2006 of the Minister of Agriculture and Rural development are amended as follows:

1. The following Clauses are added to Article 3:

“4. Proprietary name means the name given by the drug manufacturer that is different from the generic name or common name that is used domestically and internationally.

5. Good manufacturing practice (GMP) means the application of certain rules and standards to manufacture in order to ensure drug quality according to announced standards.

6. Quality standards are the criteria for technical characteristics, test methods, packaging, labeling, transport, preservation, and other requirements related to product quality.

7. Product stability means the ability of the products to sustain their intrinsic physical, chemical, biological, pharmacodynamic, pharmacokinetic properties while they are preserved in certain conditions.

8. Shelf life means the period of time that begins from the manufacturing date of the drug during which the quality criteria are satisfied while the products are preserved in certain conditions.

9. Expiry date means the date written on the package or label of the product, indicating the date on which the product still satisfies the set technical requirements is it is preserved in certain conditions.

10. Effectiveness of products means their ability to bring about expected effects on a defined population under certain conditions.

11. Pharmacodynamics means the study of pharmacological or clinical effects of drugs on the animals to describe the relationship between the effects and dosage or concentration of drugs. A pharmacodynamic effect may be a potential effect, an expected short-term effect, usually an expected clinical indicator or benefit.

12. Pharmacokinetics means the study of the absorption, distribution, metabolism, and excretion of drugs in animal bodies.

13. A batch means an amount of products that are manufactured after a cycle under a specific manufacturing order, and are consistent in terms of properties and quality”.

2. Article 5 about veterinary drug labels is amended as follows:

“Veterinary drugs sold in Vietnam must have labels and brands. Labels of veterinary drugs must comply with the Government's Decree No. 89/2006/ND-CP dated August 30, 2006 on goods labels and the Circular No. 09/2007/TT-BKHCN dated April 06, 2007 of the Ministry of Science and Technology on guidelines for the Decree No. 89/2006/ND-CP”.

3. Clause 1 Article 8 is amended as follows: “1. If the veterinary drug formula is devised by the manufacturer, or the veterinary drug is a new one, the application consists of:”

4. Point f Clause 1 Article 8 about Technical information about safety and effectiveness of products: The application must provide sufficient technical information about the safety and effectiveness of products, including necessary researches to obtain evidence:

- Clinical testing.

- Research into product toxicity:

+ Acute toxicity;

+ Long-term toxicity;

+ Mutative toxicity;

+ Carcinogenic toxicity;

+ Teratogenic toxicity;

+ Reproductive toxicity

- Research into residues in all medicated animals (in meat, eggs, and milk).

5. Point b is amended; Point c is added to Clause 4 Article 8 about places to submit application:

“b) Application for manufacturing registration: 01 package is sent to Department Of Animal Health, 01 package is kept by the applicant.

c) Application for veterinary drug testing: 01 package is sent to Veterinary drug testing Agency, which consists of an application for testing enclosed with the list of drugs being tested, quality standards, and test methods”.

6. Point b Clause 2 Article 14 about issuance of Certificates of free sale for veterinary drugs is amended as follows:

“The Director of Department of Animal Health is delegated by the Minister of Agriculture and Rural development to establish the Veterinary Drug Council. This Council shall hold meetings monthly and hold ad hoc meeting at the request of the Director of Department of Animal Health. The Council shall assess the results of application verification, testing, and request the Ministry of Agriculture and Rural Development to include veterinary drugs in the List of veterinary drugs, the List of vaccines, bioproducts, microorganisms, and chemicals in veterinary drugs that may be sold in Vietnam”.

Article 2. This Decision takes effect after 15 days from the day on which it is published in the Official Gazette.

Article 3. The Chief of office, the Director of Department of Animal Health, heads of relevant organizations and relevant individuals are responsible for the implementation of this Decision./.

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