The registration process at DAV Vietnam is quite systematic, organized and partly electronic while some part being offline too. All medicinal and food products are regulated by DAV.  A Quota system exists which is similar to an Emergency Authorization but as of now, it is very rare and difficult to obtain an EA for a product.

The normal process of filing requires preparation of Dossier as per guidelines, attestation of documents from the Vietnam embassy of the country of manufacturer, and then subsequently submission with the DAV for review.

Although samples are generally not required but the DAV can ask for them, if they feel there is a need for quality analysis. The DAV does not conduct inspections for all applications but if it is felt that the data in the Dossier requires further verification at the site of manufacture, a site audit may be conducted. 

The process can only be done through local Vietnam companies which have an account with DAV. 

The complete process usually takes between 30 to 42 months. 

Depending on requirements, we can file applications as local applicants or use your license to file !!

The DAV follows ACTD Guidelines. However the Part 1 requires translation, Certificate of Pharmaceutical Products attested from the Embassy of Country of Manufacture. 

As a general reference, we have enclosed here a checklist of Generic Drugs, fresh filing.

FDA accepts only stability studies conducted under Zone IV B stability conditions.

Need our assistance ! We, at Genedrift can handle this for you.

Click here to download the checklist.