Quyết định 98/2007/QĐ-BNN của Bộ Nông nghiệp và Phát triển nông thôn về việc bổ sung, sửa đổi Quyết định 71/2007/QĐ-BNN ngày 06/8/2007 của Bộ trưởng Bộ Nông nghiệp và Phát triển nông thôn quy định trình tự, thủ tục thử nghiệm, khảo nghiệm thuốc thú y

DECISION

SUPPLEMENTING AND AMENDING THE AGRICULTURE AND RURAL DEVELOPMENT MINISTERS DECISION No. 71/2007/QD-BNN OF AUGUST 6, 2007. PROMULGATING THE ORDER OF AND PROCEDURES FOR TESTING AND ASSAY OF VETERINARY DRUGS

THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Governments Decree No. 86/2003/ND-CP of July 18, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the November 12, 1996 Law on the Promulgation of Legal Documents and the December 16, 2002 Law Amending and Supplementing a Number of Articles of the Law on the Promulgation of Legal Documents;

Pursuant to the April 29, 2004 Ordinance on Veterinary Medicine and the Governments Decree No. 33/2005/ND-CP of March 15, 2005, detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine;

At the proposal of the director of the Veterinary Department,

DECIDES:

Article 1. To amend and supplement Articles 3 and 4, and Clause 1 of Article 8 as follows:

1. To supplement Article 3 as follows:

6. Original products means patented products which are produced according to a stable manufacturing process and have circulation permits.

7. Generic drugs means drugs manufactured after an original product with the same formula, form of preparation, route of administration, treatment indications, dosage and withdrawal period (if any).

8. Original brand-name drugs means drugs having the names of their active ingredients.

9. Testing of veterinary drug means the test and identification of technical standards and the quality of a veterinary drug.

2. To amend and supplement Article 4 regarding veterinary drugs subject to testing or assay and exempt from testing or assay, as follows:

Article 4. Veterinary drugs subject to testing or assay and exempt from testing or assay

1. Cases subject to testing

New domestically manufactured veterinary drugs upon their registration for circulation, or drugs on the List of veterinary drugs permitted for circulation in Vietnam which have undergone changes under the provisions of Clause 1, Article 58 of the Governments Decree No. 33/2005/ND-CP of March 15, 2005, detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine (below referred to as Decree No. 33).

2. Cases subject to assay

New foreign-manufactured veterinary drugs upon their registration for circulation or drugs on the List of veterinary drugs permitted for circulation which have undergone changes under the provisions of Clause 1, Article 58 of Decree No. 33.

3. Cases exempt from testing and assay

Generic drugs; original brand-name drugs (for pharmaceuticals and chemicals); imported veterinary drugs (except vaccines) which are permitted for circulation in Europe.

3. To amend Clause 1 of Article 8, as follows:

Within 30 working days after receiving a valid dossier, the Department of Veterinary shall:

............................

Article 2. This Decision takes effect 15 days after its publication in CONG BAO.

Article 3. The director of the Office, the director of the Veterinary Department, heads of units, and concerned organizations and individuals shall implement this Decision.