Circular No. 18/2018/TT-BNNPTNT Amending, supplementing, and abolishing certain provisions of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, of the Minister of Agriculture and Rural Development on veterinary drug management

CIRCULAR

Amending, supplementing, and abolishing certain Articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary drug management

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Pursuant to Decree No. 15/2017/NĐ-CP dated February 17, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Developmentof Rural Development;

Pursuant to the Law on Veterinary Medicine 2015; Pursuant to Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Law on Veterinary Medicine;

Pursuant to Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government stipulating goods labeling;

PURSUANTPursuant to Decree No. 74/2018/NĐ-CP dated May 15, 2018 of the Government amending and supplementing certain Articles of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product Quality and Goods;Pursuant to Decree No. 23/2018/NĐ-CP dated September 17, 2018 of the Government amending and supplementing certain Decrees stipulating conditions for investment and business in the agricultural sector;

Pursuant to Decree No. 154/2018/NĐ-CP dated November 9, 2018 of the Government amending and supplementing, and abolishing certain provisions on conditions for investment and business under the State Management of the Ministry of Science and Technology and certain provisions on specialized inspection;The Minister of Agriculture and Rural Development issues this Circular amending, supplementing, and abolishing certain Articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary drug management

PURSUANT40/2018/ND-CP dated October 8, 2018 of the Government amending and supplementing certain Decrees related to investment conditions, business operations, and administrative procedures under the management of the Ministry of Labor, Invalids and Social Affairs;Article 1. Amending, supplementing, and abolishing certain Articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary drug management 1. Supplementing the phrase "and methods of evaluating the suitability of veterinary drug products" in the name of Article 20; supplementing Clause 5 of Article 20 as follows:

PURSUANT"5. The evaluation of the suitability of domestically produced veterinary drug products shall be carried out according to Method 2 or Method 5 prescribed in Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology on declaration of conformity with standards and technical regulations and methods of evaluating suitability with standards and technical regulations (hereinafter referred to as Circular No. 28/2012/TT-BKHCN). In cases where the veterinary drug manufacturing facility has a valid Good Manufacturing Practice (GMP) certificate issued by the Department of Animal Health or a valid certificate of compliance with conditions for veterinary drug production issued by the Department of Animal Health, there is no need to evaluate the production process."and supplementing some articles of the Law on Government Organization 2. Supplementing Clause 4 of Article 21 as follows:

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

"4. When importing drugs and raw materials for veterinary drugs for production and business, a veterinary drug manufacturing facility that already has a valid GMP certificate or a valid certificate of compliance with conditions for veterinary drug production issued by the Department of Animal Health does not have to go through the procedure for obtaining a certificate of compliance with conditions for importing veterinary drugs of the same type that are currently permitted for production." 3. The name of Clause 3 of Article 22 is amended and supplemented as follows:

"3. Documents for importing veterinary drugs for participation in exhibitions, fairs, scientific research, prevention, and treatment of rare animals, including:"

4. Replacing the phrase "Summary of product characteristics" with "Summary of product characteristics according to the model prescribed in Appendix VIII attached hereto" at Point e Clause 2, Point đ Clause 3, and Point d Clause 5 of Article 22.

5. The name of Clause 7 of Article 22 is amended and supplemented as follows:

"7. Documents for importing raw materials for veterinary drugs (excluding documents for importing raw materials for veterinary drugs that are solvents or excipients, including the documents prescribed at Points a, d, and đ of this Clause), including:"

6. Replacing the phrase "Article 10 of Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on goods labeling (hereinafter referred to as Decree No. 89/2006/NĐ-CP)" with the phrase "Article 9 of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on goods labeling (hereinafter referred to as Decree No. 43/2017/NĐ-CP)" at Clause 4 of Article 24; replacing the phrase "Clause 1 of Article 6 of Decree No. 89/2006/NĐ-CP" with the phrase "Article 4 of Decree No. 43/2017/NĐ-CP" at Clause 1 of Article 25; replacing the phrase "Article 8 of Decree No. 89/2006/NĐ-CP" with the phrase "Article 6 of Decree No. 43/2017/NĐ-CP" at Clause 3 of Article 25; replacing the phrase "Clause 1 of Article 18 of Decree No. 89/2006/NĐ-CP" with the phrase "Clause 1 of Article 16 of Decree No. 43/2017/NĐ-CP" at Point a Clause 2 of Article 28; replacing the phrase "Article 16 of Decree No. 89/2006/NĐ-CP" with the phrase "Article 14 of Decree No. 43/2017/NĐ-CP" at Point d Clause 5 of Article 28.

7. Point a Clause 1 of Article 30 is amended and supplemented as follows:

"a) Testing and assessing the quality of produced, exported, imported, and circulated veterinary drugs nationwide;"

8. Supplementing Clause 4 of Article 30 as follows:

"4. Veterinary drug testing facilities have the following responsibilities:

a) Delivering test results on the quality of veterinary drugs or assessment results on suitability within five working days for raw materials for veterinary drugs, pharmaceuticals, chemicals, biological preparations tested for sensory, physical, and chemical indicators; fourteen days for raw materials for veterinary drugs, pharmaceuticals, chemicals, biological preparations tested for bacterial contamination and sterility indicators; twenty-one days for vaccines and antibodies tested for sterility or purity and safety indicators; sixty days for vaccines and antibodies tested for efficacy indicators from the date of sample receipt;"

b) Retaining samples of veterinary drugs of the batch being tested for quality under storage conditions specified on the label until the expiration date of the veterinary drugs."

9. Article 31 is amended and supplemented as follows:

"Article 31. Provisions on the application of veterinary drug testing methods

1. Veterinary drug testing must be conducted according to registered or designated testing methods in accordance with the law

2. For veterinary drugs without registered or temporarily designated testing methods, quality assessment is based on the recognition of testing quality results from the competent authority of the exporting country or from laboratories accredited by organizations participating in mutual recognition agreements (MRA) within the Asia-Pacific Laboratory Accreditation Cooperation (APLAC); International Laboratory Accreditation Cooperation (ILAC) or reference laboratories of the World Organization for Animal Health (OIE)."
a) Provide the results of the veterinary drug quality testing or the assessment of compliance within five working days for raw materials of veterinary drugs, pharmaceuticals, chemicals, biological products tested for sensory, physical, and chemical criteria; fourteen days for raw materials of veterinary drugs, pharmaceuticals, chemicals, biological products tested for bacterial contamination and sterility criteria; twenty-one days for vaccines and antibodies tested for sterility or purity criteria; sixty days for vaccines and antibodies tested for efficacy criteria from the date of receiving the samples.

b) Retain samples of veterinary drugs from the batch tested for quality under storage conditions indicated on the label until the expiration date of the veterinary drugs.

9. Article 31 is amended and supplemented as follows:

"Article 31. Provisions on the application of veterinary drug testing methods
1. Veterinary drug testing must be conducted according to the registered or designated testing methods as prescribed by law..

2. For veterinary drugs without registered, designated, or temporarily designated testing methods, the quality evaluation shall be based on the acceptance of the quality testing results issued by the competent authority of the exporting country or by laboratories accredited by organizations participating in mutual recognition agreements (MRA) within the framework of the Asia Pacific Laboratory Accreditation Cooperation (APLAC); International Laboratory Accreditation Cooperation (ILAC); or reference laboratories of the World Organisation for Animal Health (OIE)."

10. Add Point d Clause 1 Article 32 as follows:

"d) ASEAN vaccine standards for animals; World Organization for Animal Health (OIE) diagnostic and testing guidelines for animal vaccines and international drug standards for animals to which Vietnam is a member."

11. Article 34 is amended and supplemented as follows:

"Article 34. State inspection of the quality of imported animal drugs
1. Inspection authority: Department of Animal Health.

2. Inspection objects: Imported animal drugs must be inspected for quality upon entry into Vietnam except in cases provided for in Clause 3 of this Article.

3. Cases where imported animal drugs are exempted from quality inspection:

a) Imported animal drugs for testing, trial, and registration for circulation;

b) Imported animal drugs for treating animals temporarily imported for re-exportation or transiting through Vietnam;

c) Imported animal drugs for use in diagnosis, testing, and veterinary inspections;

d) Raw materials for animal drugs;

đ) Cases exempted from quality inspection upon importation as specified in Clause 3 Article 1 of Decree No. 74/2018/ND-CP dated May 15, 2018 of the Government amending and supplementing Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product Quality and Safety (hereinafter referred to as Decree No. 74/2018/ND-CP);

e) Cases as specified in Clause 2 Article 4 of Decree No. 154/2018/ND-CP dated November 9, 2018 of the Government amending and supplementing, abolishing some provisions on investment and business conditions in the field of management under the Ministry of Science and Technology and some provisions on specialized inspection (hereinafter referred to as Decree No. 154/2018/ND-CP).

4. Documents, procedures, and contents of state inspection of the quality of imported animal drugs:

a) Implemented according to the provisions of Clause 3 Article 1 of Decree No. 74/2018/ND-CP; Clause 1, Clause 3 Article 4 of Decree No. 154/2018/ND-CP;

b) Quality certificates are the results of conformity assessment with national technical regulations and published standards; quality certificates of exporting countries are analytical quality certificates (CoA) of manufacturers or authorized agencies of exporting countries. In cases where there is no recognized or designated conformity assessment organization or the product has not been declared compliant, the quality certificate of the imported consignment is the result of product quality testing by a designated laboratory in accordance with the law or acceptance of the manufacturer's quality test results when there is no designated testing method or acceptance of quality test results as stipulated in Clause 2 Article 31 of this Circular;

c) For the application for quality inspection of imported consignments of animal vaccines and antibodies, the importer shall be responsible for supplementing the quality certificate within 60 days from the date of application.

5. The conformity assessment of imported animal drugs shall be carried out in accordance with Method 2 prescribed in Circular No. 28/2012/TT-BKHCN. Conformity assessment does not need to assess production processes in the following cases:

a) The drug manufacturing facility already has a Good Manufacturing Practice (GMP) certificate issued by the authorized agency of the exporting country that remains valid;

b) The drug manufacturing facility already has a Quality Management System (ISO) certificate or other equivalent certificate for certain common chemicals.

6. Handling violations during the inspection process: implemented according to the provisions of Article 36 of the Law on Product Quality and Safety."

12. Repeal Article 35.

13. Clause 2 Article 36 is amended and supplemented as follows:

"2. Contents and procedures for conducting quality inspections of animal drugs circulating in the market shall be implemented in accordance with the provisions of Circular No. 26/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology on the inspection of the quality of goods circulating in the market and Circular No. 12/2017/TT-BKHCN dated September 28, 2017 of the Minister of Science and Technology amending and supplementing some articles of Circular No. 26/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology on state inspection of the quality of goods circulating in the market."

14. Clause 2 Article 45 is amended and supplemented as follows:

"2. Evaluation of research facilities for animal drugs in accordance with Article 88 of the Law on Animal Health, Article 20 of Decree No. 35/2016/ND-CP dated May 15, 2016 and Clause 5 Article 2 of Decree No. 123/2018/ND-CP dated September 17, 2018 of the Government amending and supplementing some decrees on investment and business conditions in the agricultural sector (hereinafter referred to as Decree No. 123/2018/ND-CP)."

15. Article 49 is amended and supplemented as follows:

"Article 49. Production, trading, and importing facilities for animal drugs
1. Production facilities must meet the conditions stipulated in Article 90, Clause 2 Article 91 of the Law on Animal Health, Article 12, Article 13 of Decree No. 35/2016/ND-CP dated May 15, 2016 and Clause 1 Article 2 of Decree No. 123/2018/ND-CP.
2. Trading facilities must meet the conditions stipulated in Article 92, Clause 2 Article 93 of the Law on Animal Health, Article 17 of Decree No. 35/2016/ND-CP dated May 15, 2016 and Clause 2 Article 2 of Decree No. 123/2018/ND-CP.
3. Importing facilities
a) Must meet the conditions stipulated in Article 94, Clause 2 Article 95 of the Law on Animal Health, Article 18 of Decree No. 35/2016/ND-CP dated May 15, 2016 and Clause 3 Article 2 of Decree No. 123/2018/ND-CP;

b) Can only sell raw materials for animal drugs to facilities with the necessary conditions for trading raw materials for animal drugs, facilities with the necessary conditions for producing animal drugs, and cannot sell raw materials for animal drugs to agents, retail stores selling animal drugs, individuals, or breeding and aquaculture facilities for use."

16. Add the content "Quantity of imported drugs for testing (if any)" after the content "Testing criteria:" in Appendix XVI model of the drug testing permit.

17. Add the phrase "Based on Circular No. 18/2018/TT-BNNPTNT dated November 15, 2018 of the Minister of Agriculture and Rural Development amending, supplementing, and abolishing some articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on the management of animal drugs" in the basis section of Appendices: I, II, III, IV, V, VII, X, XI, XII, XVII, XIX, XX, XXVIII, XXXI.

18. Repeal the Appendices: XXXVII, XXXVIII, XXXIX.

19. Part II. The group of evaluation criteria in the "Inspection Report on Veterinary Medicines Production Conditions" Appendix XXIII shall be amended and supplemented as follows:

a) Merge Section 1.1 and 1.2 into "There must be a safe distance from residential areas, public facilities, hospitals, veterinary hospitals, animal disease diagnostic facilities, pollution sources;"

b) Amend Section 16.3 to read "Ventilation and dust extraction equipment must be appropriate."

20. Repeal the phrase "fire prevention and firefighting" in Section 1.16.2 of the "Guidelines for Inspecting Veterinary Medicines Production Facilities" Appendix XXIII.

"5. Veterinary medicines products that have been issued circulation certificates by the Department of Animal Health before the effective date of this Circular may continue to circulate and must complete conformity declaration procedures according to the provisions of the law within two years from the effective date of this Circular;

6. Registration files for circulating veterinary medicines submitted to the Department of Animal Health before the effective date of this Circular will continue to be reviewed and issued circulation certificates by the Department of Animal Health and must complete conformity declaration procedures according to Clause 5 of this Article;

7. For imported veterinary medicines that have submitted quality inspection registration files to the inspection agency before the effective date of this Circular, quality inspections will continue to be conducted according to the provisions of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary medicine management."

Article 2. Effective Date

This Circular takes effect from February 14, 2019.

Article 3. Responsibility for Implementation

1. The Head of the Ministry's Office, the Director of the Department of Animal Health, heads of relevant units, organizations, and individuals are responsible for implementing this Circular.

2. During implementation, if there are any difficulties or need for amendments or supplements, please promptly report to the Ministry of Agriculture and Rural Development (Department of Animal Health) for consideration and resolution./.