What are the requirements for production of veterinary drugs in Vietnam? What are the procedures for granting the Certificate of eligibility for producing veterinary drugs in Vietnam?
- What are the requirements for production of veterinary drugs in Vietnam?
- What are the rights and obligations of manufacturers of veterinary drugs in Vietnam?
- What are the procedures for granting the Certificate of eligibility for producing veterinary drugs in Vietnam?
- How long is the validity of the Certificate of eligibility for producing veterinary drugs in Vietnam?
What are the requirements for production of veterinary drugs in Vietnam?
Pursuant to the provisions of Article 90 of the 2015 Law on Veterinary Medicine in Vietnam on the requirements for production of veterinary drugs as follows:
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.
What are the requirements for production of veterinary drugs in Vietnam? What are the procedures for granting the Certificate of eligibility for producing veterinary drugs in Vietnam?
What are the rights and obligations of manufacturers of veterinary drugs in Vietnam?
Pursuant to Article 91 of the 2015 Law on Veterinary Medicine in Vietnam, the rights and obligations of manufacturers of veterinary drugs in Vietnam are as follows:
Rights of establishments producing veterinary drugs:
- 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.
Obligations of establishments producing veterinary drugs:
- 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.
What are the procedures for granting the Certificate of eligibility for producing veterinary drugs in Vietnam?
Pursuant to the provisions of Article 96 of the 2015 Law on Veterinary Medicine in Vietnam, the procedures for granting of the Certificate of eligibility for producing veterinary drugs in Vietnam are as follows:
- Organizations/individuals wishing to carry out the production of veterinary drugs shall submit the application for the Certificate of eligibility for producing veterinary drugs to Department of Animal Health;
The application for the Certificate of eligibility for producing veterinary drugs shall include:
- An application form;
- A detailed description of facilities specified in Article 90 of the 2015 Law on Veterinary Medicine in Vietnam; 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.
Within 15 days from the day on which the satisfactory application is received, Department of Animal Health shall conduct an inspection on site. If the establishment satisfies the requirements, within 05 working days from the day on which the inspection finishes, Department of Animal Health shall grant the Certificate of eligibility for producing veterinary drugs. If the application is rejected, a written response containing the explanation shall be made.
How long is the validity of the Certificate of eligibility for producing veterinary drugs in Vietnam?
Pursuant to the provisions of Article 99 of the 2015 Law on Veterinary Medicine in Vietnam stipulating as follows:
Effective duration of the certificates of eligibility for producing/trading/importing of veterinary drugs
1. The certificates of eligibility for producing/trading/importing of veterinary drugs shall be effective for 05 years.
2. 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 this Law.
According to the above regulations, the Certificate of eligibility for producing veterinary drugs shall be valid for a period of 5 years.
LawNet
