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Procedure Name

Registration of importing veterinary drugs (not included in the list of veterinary drugs permitted for circulation in Vietnam)

Description

Category	Permit license
Responsible agency	Department of Animal Health (DAH) Address: No. 15/78 Giai Phong str., Phuong Mai, Dong Da, Hanoi Phone: (+84) 4.36290447 Email: quanlythuoc@gmail.com
Base on legal documents	Veterinary Law No. 79/2015/QH13 dated 19/05/2015. Decree 35/2016/ND-CP of the Government dated 15/05/2016 guiding Veterinary Law Circular 13/2016/TT-BNNPTNT on management of veterinary drugs
Processing time	7 working days
Fee	0,1% total value (not less than 100 thousand, not higher than 10 million)

Require documents

No.	Type of documents	Note
Import veterinary drugs for test or registration
1	Written registration for import of veterinary drugs (not included in the list of veterinary drugs permitted for circulation in Vietnam)	Form XXXII Circular No. 13/2016/TT-BNNPTNT
2	Certificate of Business registration or the Certificate of Enterprise registration or the investment license of the applicant	Copy
3	GMP certificate or an ISO certificate or other equivalent certificates	Original
4	Certificate of free sale (CFS, CPP or MA) issued by a competent body of the country of manufacture	Original
5	Certificate of analysis (CoA) of the manufacturer	Original
6	Sample product labels

Import veterinary drugs without the certificate of free sale which serving the prevention and fighting against emergency animal epidemic and/or serving disaster recovery
1	Written registration for import of veterinary drugs (not included in the list of veterinary drugs permitted for circulation in Vietnam)	Form XXXII Circular No. 13/2016/TT-BNNPTNT
2	Certificate of Business registration or the Certificate of Enterprise registration or the investment license of the applicant	Copy
3	GMP certificate or an ISO certificate or other equivalent certificates	Original
4	Certificate of free sale (CFS, CPP or MA) issued by a competent body of the country of manufacture	Original
5	Certificate of analysis (CoA) of the manufacturer	Original
6	Sample product labels

Import veterinary drugs to be displayed at a fair, an exhibition or for scientific research
1	Written registration for import of veterinary drugs (not included in the list of veterinary drugs permitted for circulation in Vietnam)	Form XXXII Circular No. 13/2016/TT-BNNPTNT
2	Certificate of Business registration or the Certificate of Enterprise registration or the investment license of the applicant	Copy
3	Documents proving the purposes of importing veterinary drugs	Copy
4	Certificate of analysis (CoA) by the manufacturer	Original
5	Summary of product characteristics (SmPC)
6	The model of the product label

Import veterinary drugs used for animals which are temporarily imported or transited through Vietnam’s territory; temporarily imported for re-export or outward processing under a contract which a foreign organization or individual
1	Written registration for import of veterinary drugs (not included in the list of veterinary drugs permitted for circulation in Vietnam)	Form XXXII Circular No. 13/2016/TT-BNNPTNT
2	Certificate of analysis (CoA) by the manufacturer	Original
3	Documents proving the purposes of importing veterinary drugs	Copy
4	The model of the product label

Import veterinary drugs and materials thereof or microorganisms serving the research and manufacture of veterinary drugs, diagnosis or test of veterinary drug
1	Written registration for import of veterinary drugs (not included in the list of veterinary drugs permitted for circulation in Vietnam)	Form XXXII Circular No. 13/2016/TT-BNNPTNT
2	Certificate of Business registration or the Certificate of Enterprise registration or the investment license of the applicant	Copy
3	Certificate of analysis (CoA) by the manufacturer	Original
4	Summary of product characteristics (SmPC)

Process steps:

Step 1	Send registration documents for DAH
Step 2	DAH evaluates and respond to the enterprise

Process map:

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This procedure apply to theses Measures.

name	description
Import of veterinary drugs requires permission	Any veterinary drug without CFS or not included in the List of veterinary drugs permitted for sale in Vietnam shall be imported in following cases: a) Materials used for manufacture of veterinary drugs with CFS; b) Samples used for study, testing, laboratory diagnosis, testing, or registration for sale; c) Chemical standards used for veterinary diagnosis or testing; veterinary drugs displayed in trade fairs, exhibitions or used for prevention and treatment for precious and rare animals; d) Medical aid of international organizations and types of other non-commercial imports; dd) Prevention and treatment of urgent epidemic diseases, disaster recovery.

name

description

Import of veterinary drugs requires permission

Any veterinary drug without CFS or not included in the List of veterinary drugs permitted for sale in Vietnam shall be imported in following cases: a) Materials used for manufacture of veterinary drugs with CFS; b) Samples used for study, testing, laboratory diagnosis, testing, or registration for sale; c) Chemical standards used for veterinary diagnosis or testing; veterinary drugs displayed in trade fairs, exhibitions or used for prevention and treatment for precious and rare animals; d) Medical aid of international organizations and types of other non-commercial imports; dd) Prevention and treatment of urgent epidemic diseases, disaster recovery.