Thông tư 09/2024/TT-BNNPTNT sửa đổi Thông tư 13/2016/TT-BNNPTNT quy định về quản lý thuốc thú y do Bộ trưởng Bộ Nông nghiệp và Phát triển nông thôn ban hành

CIRCULAR

AMENDMENTS TO SOME ARTICLES OF CIRCULAR NO. 13/2016/TT-BNNPTNT DATED JUNE 02, 2016 OF THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT ON VETERINARY DRUG MANAGEMENT

Pursuant to the Government’s Decree No. 105/2022/ND-CP dated December 22, 2022 on functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to the Law on Veterinary Medicine dated June 19, 2015;

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

The Minister of Agriculture and Rural Development hereby promulgates Circular on amendments to some articles of Circular No. 13/2016/TT-BNNPTNT dated June 02, 2016 of the Minister of Agriculture and Rural Development on veterinary drug management.

Article 1. Amendments to some articles of Circular No. 13/2016/TT-BNNPTNT dated June 02, 2016 of the Minister of Agriculture and Rural Development on veterinary drug management

1. Clause 5 Article 20 (added by clause 1 Article 1 of the Circular No. 18/2018/TT-BNNPTNT dated November 15, 2018) shall be amended as follows:

 “5. Evaluation of the conformity of veterinary drugs domestically produced shall be carried out in accordance with the Method 1 (test on typical sample) specified in the Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology”.

2. Clause 5 Article 34 (amended by clause 11 Article 1 of the Circular No. 18/2018/TT-BNNPTNT dated November 15, 2018) shall be amended as follows:

“5. Evaluation of the conformity of veterinary drugs imported shall be carried out in accordance with the Method 1 (test on typical sample) specified in the Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology”.

Article 2. Transitional provisions

1. Organizations and individuals may use veterinary drug analysis or testing results used to evaluate the conformity by the Method 2 or the Method 5 before the effective date of this Circular to evaluate the conformity by the Method 1 specified in the Circular No. 28/2012/TT-BKHCN.

2. Regarding veterinary drugs that are pharmaceutical products or chemicals domestically produced with testing results issued by designated laboratories according to National Technical Regulation on Veterinary Drug - General Requirement (QCVN 01-187:2018/BNNPTNT), organizations and individuals may use such testing results to make self-assessment reports serving declaration of the conformity of veterinary drugs according to regulations.

3. Regarding veterinary drugs having their conformity with National Technical Regulation on Veterinary Drug - General Requirement (QCVN 01-187:2018/BNNPTNT) evaluated by the Method 2 or the Method 5 specified in the Circular No. 28/2012/TT-BKHCN before the effective date of this Circular, organizations and individuals shall follow procedures for declaring their conformity as prescribed by law.

4. The Department of Animal Health shall continue to inspect the validity of dossiers on declaration of conformity of veterinary drugs submitted to the Department of Animal Health before the effective date of this Circular and issue a Notification of receipt of dossiers on declaration conformity of veterinary drugs according to regulations of law at the time on which such dossiers are submitted.

5. The Notification of receipt of dossiers on declaration of conformity of veterinary drugs issued before the effective date of this Circular shall remain valid until its expiry date indicated in the Notification.  Organizations and individuals shall implement supervision according to the Method 2 or the Method 5 specified in the Circular No. 28/2012/TT-BKHCN.

Regarding veterinary drugs issued with the Notification of receipt of dossiers on declaration of conformity before the effective date of this Circular, if the evaluation of the conformity of veterinary drugs by the Method 1 is required, organizations and individuals shall declare their conformity in accordance with the Circular No. 28/2012/TT-BKHCN.

Article 3. Implementation clause

1. This Circular comes into effect from July 15, 2024.

2. The Director of the Department of Animal Health, Heads of units affiliated to the Ministry and relevant organizations and individuals shall be responsible for implementing this Circular.

Difficulties that arise during the implementation of this Circular or amendments (if any) should be reported to the Department of Animal Health (affiliated to the Ministry of Agriculture and Rural Development) for consideration and settlement./.