I. The content of one dossier for registration of veterinary products
The dossier for registration of veterinary products must be made in 03 sets, printed on the A4-sized papers, arranged in accordance with regulated order.
One dossier for registration of veterinary products includes:
- Section 1: The cover page of the dossier (Sample 1); index of the dossier (Sample 2);
- Section 2: Application for registration of veterinary products (Sample 3);
- Section 3: Summary of product characteristics;
- Section 4: Labels of veterinary products;
- Section 5: Technical information about the product quality;
- Section 6: Technical information about the safety level and the effects (validity) of the product;
- Section 7: Different kinds of Certificates GMP, ISO… If the Certificates are the copies, they must be certified by the competent authorities.
- Section 8: Other relating documents (The documents which has been analysed by the producers and the State Control Authorities of veterinary products, the testing results…).
Please note that the dossier for registration of imported products must be written in the Vietnamese languages or English. The summary of Product characteristics must be written in the English language.