Question: We are pharmaceuticals company from Singapore, we would like to registered of Products in Vietnam MOH. Please share the quotation for registering one dossiers for one products.
Answer:
Regarding your enquiries concerning the subject matter, we would like to advise you on procedure and our updated fee schedule in relation to the pharmaceutical registration proceeding in Vietnam as follows:
- FEE SHEDULE
| Description | Attorney’s Fees
(USD) |
| Fee for filing an application for one generic products. | 2400 |
| TOTAL | 2400 |
In words: Two thousands and four hundred US Dollars
Note: This fee includes preparing basic records, filing, following, contacting with specialist in the usual case. In case of raised specific cases it will be solved without more incurring due to unpredictable difficulties. The fee excludes 10% VAT.
- PROCEDURE AND TIMELINE
– The duration of a pharmaceutical registration is around 02 years.
- REQUIRED DOCUMENTS AND INFORMATION
3.1. Legal documents of company:
– Certificate of business registration
– Certificate of eligibility for drug trading
– Certificates of “Good Distribution Practices ” (GDP)
3.2. Manufacturer documents
– Profile overview of Manufacturers
– Certificate of Pharmaceutical according to WHO (CPP)
– Power of Attorney (POA)
We hope the above is of your assistance. Should you have any inquiry, please do not hesitate to contact us.
