Wednesday, January 24, 2018

Articles

SECTINON 6: Information about the safety and the effects (validity) of the product

The applicant must be completely responsible for:
- The safety of the product for the animal health, health of the consumers of the products that originate from animal, the user of veterinary products in prevention, treatment for animal and the environment.
- The effect (validity) of the products for the animals using the products.
The applicant must provide the technical information to prove the above two matters in the dossier.
For the products which are produced according to the copied formula from other producers, the producer does not need to provide information about the safety and the validity of those products.

II. Time frame:

1. The agency to which the registration document has been submitted shall, within fifteen (15) days from the receipt of the dossier, be responsible for answering the result, or notifying organizations or individuals whose dossiers are not satisfactory for supplementary information.

2. Within sixty (60) days from the date of receipt of legitimate document, the Department of Animal Health or the National Fisheries Quality Assurance and Veterinary Directorate shall be responsible for submitting results of document evaluation to the professional Scientific Committee set up by the Ministry of Agriculture and Rural Development and/or the Ministry of Fisheries. The Committee shall convene regularly or when required for approval of registration dossiers and request the Ministry of Agriculture and Rural Development or the Ministry of Fisheries to accredit and add the products registered into the List of Veterinary Drugs or the List of Biological Products, Microorganisms and Chemicals for veterinary used that are permitted for marketing and use in Vietnam.
For our previous cases, it took approximately 6-7months to obtain the registration for veterinary products.

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