Decision No. 100/2007/QĐ-BNN amends and supplements certain provisions of Decision No. 72/2007/QĐ-BNN on veterinary drug quality inspection. This document provides more detailed regulations on the importation of raw materials for veterinary drugs and requires enterprises to establish files for review by the Animal Health Department.
적용 범위
[Animal Health Department, production and business establishments, importers, storage facilities, transportation units of veterinary drugs]
핵심 사항
- Enterprises must establish files and submit them to the Animal Health Department before importing raw materials for veterinary drugs that have not yet been registered (Article 10).
- The Animal Health Department shall review and confirm the import file within five working days from the date of receipt of a valid file (Article 10).
- Remove the requirement for quality inspection of each batch of veterinary drugs already included in the list of products permitted for circulation in Vietnam (Article 10).
- Enterprises must provide certificates of free trade, product circulation certificates, or product circulation permits when importing raw materials for veterinary drugs (Point b Clause 2 Article 11).
- Remove the requirement to provide quality declaration files when importing raw materials for veterinary drugs (Point f Clause 2 Article 11).
🌐 이 문서의 사회적 영향
- To enhance the management of veterinary drug quality and protect the health of livestock.
- To reduce inspection costs for enterprises when importing raw materials for veterinary drugs already included in the list of products permitted for circulation in Vietnam.
❓ 자주 묻는 질문
What documents must enterprises provide when importing raw materials for veterinary drugs?
Enterprises must provide certificates of free trade, product circulation certificates, or product circulation permits (Point b Clause 2 Article 11).
How long does it take to review the import file for raw materials for veterinary drugs?
The Animal Health Department must review and confirm the import file within five working days from the date of receipt of a valid file (Article 10).
전문
Pursuant to …;
Regarding supplementing and amending Decision No. 72/2007/QĐ-BNN dated August 6, 2007 of the Minister of Agriculture and Rural Development on veterinary drug quality inspection
______________________
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 Legislative Regulatory Acts issued on November 12, 1996; the Law Amending and Supplementing Certain Provisions of the Law on Legislative Regulatory Acts issued on December 16, 2002;
Pursuant to the Veterinary Law issued on 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 Veterinary Law;
CONSIDERING the proposal of the Director of the Department of Animal Health,
DECISION:
Article 1. Amend Article 10, amend and supplement Point b Clause 2 Article 11 as follows:
1. Amend Article 10
a) Amend and supplement Clause 2 as follows:
"1. For veterinary drugs already listed in the Catalogue of Permitted Circulation in Vietnam; raw materials, excipients, solvents, chemicals for veterinary drugs when imported do not require quality inspection for each consignment. The inspection shall be carried out according to the following regulations:
a) Periodic inspection:
Annually, based on actual conditions, the Department of Animal Health shall organize sampling of veterinary drugs and raw materials at production, trading, import, storage, and transportation facilities for quality inspection;
b) Spot inspection shall be conducted when there are complaints or reports about the quality of veterinary drugs or upon request of competent authorities."
b) Amend Clause 2 as follows:
"2. Prior to importing raw materials listed in the Catalogue of Permitted Circulation of Veterinary Drugs in Vietnam but without registration number; solvents, excipients, chemicals for veterinary drugs, enterprises must prepare documents in accordance with Clause 2 of Article 11 of this Regulation and submit them to the Department of Animal Health.
Within five working days from the date of receipt of valid documents, the Department of Animal Health shall review and confirm the import documents so that the enterprise can proceed with customs clearance procedures."
c) Amend Clause 3 as follows: delete Clause 3
2. Amend and supplement Point b Clause 2 Article 11
"a) ...
b) Free Sale Certificate (FSC) or Certificate of a Pharmaceutical Product (CPP) or Marketing Authorization (MA);
…………
f) Delete Point F"
Article 2. This Decision takes effect fifteen days after its publication in the Official Gazette of the Government.
Article 3. The Director of the Office, the Director of the Department of Animal Health, Heads of units, organizations, and individuals concerned are responsible for implementing this Decision./.
DEPUTY MINISTER
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