Medicine registration For Circulation In Viet Nam
1. Administrative records and product information.
- Cover page ( form 1/TT)
- Table of content
- Application for registration ( Form 2A/TT)
- Authorization Letter ( if any) ( Form 3/TT)
- The certificate of operating in medicine, medicine raw material in Vietnam
FSC Certificate if foreign medicine company does not have CPP
- GMP certificate of the foreign manufacturing company if the medicine registration unit hands the FSC or CPP certificate without confirmation of GMP standards. Incase many manufacturing units took place in the process of medicine manufacture, the medicine registration unit must hand GMP certificates of all these manufacture units;
- Labeling materials: 02 sets of designed labeling materials. For foreign medicine, 01 original set of labeling materials circulating in country of origin is also required. These materials are encloses into the A4 paper with stamp of registration unit or manufacture unit.
- Product information: Package insert for generic medicine with stamp of registration unit or manufacture unit.
- The overall record of manufacture ( Form 4/TT). In case one product is produced through many steps, overall record must be the record of all manufacturer joining process of making the product before delivering to the market.
2. Time frame
Under the Vietnamese legal regulation, it take 06 months, then Ministry of Health will issue a Notification requesting the supplementation or amendment. Therefore, it normally take up to 8-9 months to obtain visa number after accurate and sufficient amendment. However, after executing the new regulations on medicine registration, it may take 12-15 months to obtain visa.