Legal basis

• Law on Veterinary Medicine No. 79/2015/QH13 dated June 19, 2015, of the National Assembly;
• Decree No. 35/2016/ND-CP dated May 15, 2016, of the Government detailing several articles of the Law on Veterinary Medicine;
• Circular 13/2016/TT-BNNPTNT dated June 2, 2016, of the Ministry of Agriculture and Rural Development on the management of veterinary drugs;
• Circular No. 04/2012/TT-BTC dated January 5, 2012, of the Ministry of Finance guiding the collection, payment, and management of fees and charges in veterinary work
• Circular No. 113/2015/TT-BTC amending Circular 04/2012/TT-BTC regulating the collection, payment, management, and use of fees and charges in veterinary work

Steps

Step 1: Organizations and individuals submit dossiers to the Department of Animal Health;

Step 2: Department of Animal Health considers granting import license; In case of refusal, a written reply must be given clearly stating the reason.

The dossiers

1.An application file for importing veterinary drugs without a certificate of circulation for urgent prevention and control of animal diseases and overcoming consequences of natural disasters includes:

• An application for registration of import of veterinary drugs made according to the form specified in Appendix XXXII issued together with Circular 13/2016/TT-BNNPTNT.
• A copy of the business registration certificate or the certificate of business registration or investment license of the enterprise with the appropriate business lines of the organization or individual applying for the license to import veterinary drugs;
• Certificate of Good Manufacturing Practice (GMP) or certificate of quality management system (ISO) or other equivalent certificates for some common chemicals;
• Certificate of product circulation (CFS, CPP, MA) issued by the competent state agency of the exporting country;
• Manufacturer’s product quality analysis (CoA) sheet;
• Label of the product(s).

2. A dossier of import of veterinary drug samples for testing, testing, and registration of circulation includes:

• An application for registration of import of veterinary drugs made according to the form specified in Appendix XXXII issued together with Circular 13/2016/TT-BNNPTNT;
• A copy of the business registration certificate or the certificate of business registration or the investment license of the organization or individual applying for a license to import veterinary drugs, for the organization that imports it for the first time;
• Certificate of Good Manufacturing Practice (GMP) or certificate of quality management system (ISO) or other equivalent certificates for some common chemicals;
• Certificate of product circulation (CFS, CPP, MA) issued by the competent state agency of the exporting country;
• Manufacturer’s product quality analysis (CoA) sheet;
• Summary of product features.

Time

05 working days

The competent authority

Department of Animal Health

If you need more detailed advice and answers as well as how to access this service, please contact directly our Lawyer Nhat Nam via hotline: 0912.35.65.75, 0912.35.53.53 or call the toll free legal consultation hotline 1900.6575 or send a service request via email: lienheluathongbang@gmail.com

Wishing you and your family good health, peace, and success

Best regards!