Decision No. 99/2007/QĐ-BNN amending and supplementing Decision No. 10/2006/QĐ-BNN dated February 10, 2006 of the Minister of Agriculture and Rural Development on procedures for registering production, importation, and circulation of veterinary drugs, raw materials for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary medicine.

Pursuant to …;

Amending and supplementing Decision No. 10/2006/QĐ-BNN dated February 10, 2006

of the Minister of Agriculture and Rural Development on procedures for registering the production, importation, and circulation of veterinary drugs, raw materials for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary medicine

lưu hành thuốc thú y, nguyên liệu làm thuốc thú y, chế phẩm sinh học, vi sinh vật,

hóa chất dùng trong thú y

____________________________

THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to Decree No. 86/2003/NĐ-CP dated July 18, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Law on Enacting Legal Normative Documents dated November 12, 1996; and the Law Amending and Supplementing Certain Provisions of the Law on Enacting Legal Normative Documents dated December 16, 2002;

Pursuant to the Ordinance on Veterinary Medicine dated April 29, 2004, and Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing the implementation of certain provisions of the Ordinance on Veterinary Medicine;

CONSIDERING the proposal of the Director of the Department of Animal Health,

DECISION:

Article 1. Supplementing Article 3, amending Article 5, amending Clause 1, Article 8, supplementing Point f, Clause 1 and Clause 4, Article 8, and Point b, Clause 2, Article 14 of the Regulations on Procedures for Registering the Production, Importation, and Circulation of Veterinary Drugs, Raw Materials for Veterinary Drugs, Biological Preparations, Microorganisms, and Chemicals Used in Veterinary Medicine issued together with Decision No. 10/2006/QĐ-BNN dated February 10, 2006 of the Minister of Agriculture and Rural Development as follows:

1. Supplementing Article 3...

“ 4. Trade name: Is the name given by the drug manufacturer that differs from the generic name, common name, and international name.

5. Good Manufacturing Practice (GMP): Refers to the application of principles and standards during production to ensure that the quality of the drug meets the published quality standards.

6. Product Quality Standards: Are technical specifications, testing methods, packaging requirements, labeling, transportation, storage requirements, and other relevant requirements related to product quality.

7. Product Stability: Is the ability to maintain inherent characteristics regarding physical, chemical, biological, pharmacological, and pharmacokinetic properties within specified limits when stored under defined conditions.

8.Shelf Life of the Product: Is the period from the date of manufacture until the product retains all specified quality criteria under defined storage conditions.

9. Expiry Date of the Product: Is the date marked on the package or label indicating the time when the product still meets established technical specifications if stored under defined conditions.

10. Efficacy of the Product: Is the capability of the product to produce the desired effect on individuals within a defined population for a specific purpose under defined usage conditions.

11. Pharmacodynamics: Is the study of the pharmacological or clinical effects of a drug on individuals to describe the relationship between effect and dose or drug concentration. A pharmacodynamic effect may be a potential side effect, a short-term desired effect, often a clinical indicator or anticipated final clinical benefit.

12. Pharmacokinetics: Is the study of the processes of absorption, distribution, metabolism, and excretion of pharmaceuticals in animal bodies.

13. Batch of Product: Is a quantity of product produced in a defined production cycle and according to a specific production order, uniform in characteristics and quality.

2. Amending Article 5 on the labeling of veterinary drugs as follows:

"Veterinary drugs circulating in the territory of Vietnam must have labels and brand marks. The labeling of veterinary drugs must comply with Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling and Circular No. 09/2007/TT-BKHCN dated April 6, 2007 of the Ministry of Science and Technology guiding the implementation of certain provisions of Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling."

3. Amending Clause 1, Article 8: "1. For veterinary drugs with formulas researched independently by the manufacturer, new veterinary drugs, the registration dossier shall include:"

4. Point f, Clause 1, Article 8 Technical information on safety and efficacy of the product: The registration dossier must provide complete technical information on the safety and efficacy of the product including necessary studies to provide data proving:

- Clinical trials.

- Toxicity studies of the product:

+ Acute toxicity;

+ Chronic toxicity;

+ Mutagenicity;

+ Carcinogenicity;

+ Teratogenicity;

+ Reproductive toxicity.

- Residue studies in all designated animal species (meat, eggs, and milk).

5. Amending Point b, supplementing Point c, Clause 4, Article 8 on the place of receipt and quantity of dossiers to be submitted as follows:

"b) Registration dossier for production: One set sent to the Department of Animal Health and one set retained at the registration facility.

c) Registration dossier for veterinary drug testing: One set sent to the State Veterinary Drug Testing Agency, including: Application for testing along with the list of drugs to be tested; Product quality standards; Testing methods."

6. Amending Point b, Clause 2, Article 14 on the review and issuance of certificates for the circulation of veterinary drugs as follows:

"The Scientific Council for Veterinary Drugs, authorized by the Minister of Agriculture and Rural Development through the Director of the Department of Animal Health, decides to establish the Council. The Council convenes monthly meetings and extraordinary meetings upon request of the Director of the Department of Animal Health. The Council's task is to evaluate the results of dossier reviews, testing, trial, and field testing of veterinary drugs and propose recognition by the Ministry of Agriculture and Rural Development to include them in the List of Permitted Veterinary Drugs, Vaccines, Biological Preparations, Microorganisms, and Chemicals Used in Veterinary Medicine in Vietnam."

Article 2. This Decision takes effect fifteen days after its publication in the Official Gazette of the Government.

Article 3The Head of the Office, the Director of the Department of Animal Health, Heads of units, organizations, and individuals concerned are responsible for implementing this Decision./.