Requirements for production of veterinary drugs according to the law in Vietnam

Requirements for production of veterinary drugs according to the law in Vietnam (Source: Internet)

1. What is veterinary drug?

According to Clause 21, Article 3 of the Law on Veterinary Medicine 2015,  veterinary drugs means substances or compounds including medicinal products, Vaccine, bio-preparations, microorganisms and chemicals that are permitted to used for animals for prevention, treatment, diagnosis, rehabilitation and/or improvement of growing and reproductive functions of animals.

In which, finished veterinary drugs means veterinary drugs that have undergone all the manufacturing stages, including the packaging and labeling conducted in facilities passing the quality inspection and satisfy the quality norms according to the registration documents.

(Clause 22, Article 3 of the Law on Veterinary Medicine 2015)

2. Requirements for production of veterinary drugs in Vietnam

Pursuant to Article 90 of the Law on Veterinary Medicine 2015, organizations/individuals that perform the production of veterinary drugs shall satisfy the following conditions

- Having the Certificate of Enterprise registration;

- Location, workshops, drug warehouses shall be designed with area and distance ensuring the safety for human, animals and the environmental protection;

- Provided with equipment appropriate to the scale of production and quality inspection of each type of veterinary drug;

- Sewage treatment system shall be equipped according to veterinary hygiene standards and the law provisions on environmental protection;

- People who directly carry out the management of production and analysis of veterinary drugs shall have veterinary practice certificates in terms of production and analysis of veterinary drugs;

- People who directly perform the production of veterinary drugs shall be provided with training in appropriate professional skills;

- Having the Certificate of eligibility for producing veterinary drugs.

3. Application for the Certificate of eligibility for producing veterinary drugs in Vietnam

Specifically, in Clause 1, Article 96 of the Law on Veterinary Medicine 2015, an application for the Certificate of eligibility for producing veterinary drugs shall include:

- An application form;

- A detailed description of facilities specified in Section 2;

A list of veterinary drugs to produce;

- The Certificate of Enterprise registration;

- The veterinary practice certificate;

- A copy of the written approval for the report on environmental impact assessment by regulatory agencies.

4. Effective duration of the certificates of eligibility for producing/trading/importing of veterinary drugs in Vietnam

The effective duration of the certificates of eligibility for producing/trading/importing of veterinary drugs is prescribed as follows:

- The certificates of eligibility for producing/trading/importing of veterinary drugs shall be effective for 05 years.

- 03 months before the expiration of the certificates of eligibility for producing/trading/importing of veterinary drugs, organization/individual wishing to continue the production, trading or import of veterinary drugs shall submit an application for extension of the certificate.

Procedures for extensions of the certificate shall comply with the regulation on clause 2 Article 96, clause 2 Article 97 and clause 2 Article 98 of Law on Veterinary Medicine 2015.

(Article 99 of the Law on Veterinary Medicine 2015)

5. Rights and obligations of manufacturers of veterinary drugs in Vietnam

5.1. Rights of establishments producing veterinary drugs

According to Clause 1, Article 91 of the Law on Veterinary Medicine 2015, rights of establishments producing veterinary drugs are as follows:

- Perform the production of veterinary drugs that are granted the Certificate of sale of veterinary drugs in Vietnam;

- Import veterinary drugs, veterinary drug ingredients for production or re-export according to the contract with foreign organizations and individuals; obtain or grant concession according to the regulations;

- Provide information or advertisement of veterinary drugs according to the regulations on advertising;

- Other rights according to the relevant law provisions.

5.2. Obligations of establishments producing veterinary drugs

According to Clause 2, Article 91 of the Law on Veterinary Medicine 2015, obligations of establishments producing veterinary drugs are as follows:

- Produce veterinary drugs according to the standards they have declared;

- Comply with the regulations on analysis, preservation and distribution of veterinary drugs and good manufacturing production;

- Take responsibilities for the quality of veterinary drugs they produced and shall sell only the conformable veterinary drugs;

- Retain the samples of veterinary drugs sorted by production batches for at least 06 months from the day on which they expires;

- Supervise the veterinary drugs they produced, make notification and immediately recall the whole batch of the drug if such type of drug is discovered unconformable;

- Provide compensation for the damage they cause according to the law provisions;

- Provide sufficient information for the inspection and assessment of the production of veterinary drugs according to the law provisions;

- Owners of veterinary drug-producing establishments shall provides training, guidelines for use and prevention of unexpected effect of veterinary drugs; provide professional training for people who directly produce veterinary drugs;

- Comply with other law provisions on fire prevention, chemical safety, labor safety and environment protection.

Thanh Rin

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