Circular No. 09/2024/TT-BNNPTNT amends and supplements certain provisions of Circular No. 13/2016/TT-BNNPTNT on veterinary drug management. This document stipulates the evaluation of the suitability of domestically produced and imported veterinary drugs through typical sample testing methods.
Đối tượng áp dụng
Organizations and individuals producing, importing, and trading in veterinary drugs
Các điểm cốt lõi
- Domestic organizations and individuals producing veterinary drugs must evaluate suitability according to the typical sample testing method (Article 20).
- Imported veterinary drugs are also evaluated for suitability according to the typical sample testing method (Article 34).
- Test results prior to the effectiveness of this Circular can still be used to assess suitability under the new method (Article 2, Clause 1).
- Veterinary drugs that have been declared compliant before the effectiveness of this Circular continue to be valid until the expiration date stated in the notification (Article 2, Clause 5).
- Organizations and individuals must implement procedures for declaring compliance in accordance with the law (Article 2, Clause 3).
🌐 Tác động xã hội từ văn bản này
- To enhance the quality management of domestically produced and imported veterinary drugs.
- To improve the effectiveness of evaluating the suitability of veterinary drugs.
- To facilitate organizations and individuals who have test results prior to the effectiveness of this Circular.
❓ Câu hỏi thường gặp
What evaluation method must imported veterinary drugs be assessed under?
Must be evaluated for suitability according to the typical sample testing method (Article 34).
How can test results prior to the effectiveness of this Circular be utilized?
Can be used to assess suitability under the new method (Article 2, Clause 1).
Until when can veterinary drugs declared compliant prior to the effectiveness of this Circular continue to be used?
Valid until the expiration date stated in the notification (Article 2, Clause 5).
What evaluation method must domestic organizations and individuals producing veterinary drugs follow?
Must evaluate suitability according to the typical sample testing method (Article 20).
How will organizations and individuals who submitted declaration compliance applications before the effectiveness of this Circular be handled?
Will continue to be reviewed for validity by the Animal Health Department and issuance of receipt notifications (Article 2, Clause 4).
Toàn văn
AND RURAL DEVELOPMENT
CIRCULAR
Amending and supplementing certain Articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development on veterinary drug management
Article 1. Amending and supplementing certain Articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development on veterinary drug management
1. Amending and supplementing Clause 5 of Article 20 (supplemented by Clause 1 of Article 1 of Circular No. 18/2018/TT-BNNPTNT dated November 15, 2018) as follows:
"5. The assessment of the suitability of domestically produced veterinary drugs shall be conducted according to Method 1 (Typical Sample Testing) as stipulated in Circular No. 28/2012/TT-BKHCN dated December 12, 2012, issued by the Minister of Science and Technology on the announcement of conformity with standards and technical regulations and methods for assessing compliance with standards and technical regulations (hereinafter referred to as Circular No. 28/2012/TT-BKHCN)."
2. Amending and supplementing Clause 5 of Article 34 (amended and supplemented by Clause 11 of Article 1 of Circular No. 18/2018/TT-BNNPTNT) as follows:
"5. The assessment of the suitability of imported veterinary drugs shall be conducted according to Method 1 (Typical Sample Testing) as stipulated in Circular No. 28/2012/TT-BKHCN."
1. For testing results of veterinary drugs (quality analysis report, testing report, testing result report) that have been used to assess suitability under Method 2 or Method 5 before the effective date of this Circular, organizations and individuals may continue to use these testing results to assess suitability under Method 1 as prescribed in Circular No. 28/2012/TT-BKHCN.
2. For domestically produced veterinary drugs that are pharmaceuticals or chemicals which have been tested and certified by designated organizations in accordance with National Technical Regulation Veterinary Drugs - General Requirements (QCVN 01-187:2018/BNNPTNT), organizations and individuals may use these testing results to compile a self-assessment report for the declaration of conformity with veterinary drug technical regulations as prescribed.
Article 2. Transitional provisions
3. Veterinary drugs that have been assessed for suitability with National Technical Regulation Veterinary Drugs - General Requirements (QCVN 01-187:2018/BNNPTNT) under Method 2 or Method 5 as prescribed in Circular No. 28/2012/TT-BKHCN before the effective date of this Circular, organizations and individuals must follow the procedures for declaring conformity with technical regulations as prescribed by law.
4. Declaration of conformity with technical regulations for veterinary drugs submitted to the Department of Animal Health before the effective date of this Circular will continue to be reviewed for validity and a Notice of Receipt of Declaration of Conformity with Technical Regulations for Veterinary Drugs will be issued in accordance with the law at the time of submission.
5. Notices of Receipt of Declaration of Conformity with Technical Regulations for Veterinary Drugs issued before the effective date of this Circular will remain valid until their expiration date as stated in the Notice. Organizations and individuals must continue to monitor according to Method 2 or Method 5 as prescribed in Circular No. 28/2012/TT-BKHCN. For veterinary drugs that have received a Notice of Receipt of Declaration of Conformity before the effective date of this Circular, if there is a need to assess suitability under Method 1, organizations and individuals must declare conformity with technical regulations for veterinary drugs in accordance with Circular No. 28/2012/TT-BKHCN.
1. This Circular takes effect from July 15, 2024.
2. The Director of the Department of Animal Health, heads of units under the Ministry, and related organizations and individuals are responsible for implementing this Circular. In the course of implementation, if there are any difficulties or need for amendments or supplements, they are requested to promptly report to the Ministry of Agriculture and Rural Development (through the Department of Animal Health) for consideration and resolution./.
Article 3. Implementation Provisions
1. This Circular shall take effect from July 15, 2024.
2. The Director of the Department of Animal Health, heads of units under the Ministry, and related organizations and individuals are responsible for implementing this Circular. In the course of implementation, if there are any difficulties or need for amendments or supplements, it is requested that relevant agencies, organizations, and individuals promptly reflect these issues to the Ministry of Agriculture and Rural Development (through the Department of Animal Health) for consideration and resolution./.
DEPUTY MINISTER
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