Pharmaceutical Product Registration in Vietnam

SB Law provides the legal service for Pharmaceutical Product Registration in Vietnam, we would like to list required documents and legal procedure for client’s reference:

PART A:              ADMINISTRATIVE DOCUMENTS AND PRODUCT INFORMATION

PART B:               QUALITY DOCUMENTS

To be made in accordance with Part II of ACTD(ASEAN COMMEN TECHNICAL DOCUMENTS)

2.         TIMING SCHEDULE

2.1. Dossier preparation:

• To complete checklist of application dossier(s): 05-10 working day from the date of receipt of dossier from client.
• To review and draft forms for manufacturer to complete: 15 – 30 working days from the date of receipt of dossier from client.

Note:

• The above timing schedule may be longer depending on the quantity of application dossier to be dispatched to Service Provider;
• Only when receiving all required documents (sufficient dossier) as mentioned in the above list, do we submit application dossier to DAV and following up examination process.

2.2. Following up the appraisal process:

Within 14 working days from the date that clients provide SERVICE PROVIDER with sufficient required documents, SERVICE PROVIDER commit to submit the dossier to DAV.

Except other than clientshave any different, timing schedule to follow up the appraisal process shall be 06 months - 08 months from the date of lodging sufficient dossier to DAV.

3.         SERVICE FEE AND MODE OF PAYMENT

3-A      SERVICE FEE

3-B      SERVICE FEE STRUCTURE

Service fee as mentioned above is inclusive of the following:

• Translation fee;
• Communication fee;
• Photocopy fee.

Service fee as mentioned aboveis exclusive of the following:

• Official fee of VND1,500,000 (One million and five hundred thousand Vietnam dong) per each dossier to be submitted;
• 10% value added tax on the total service fee;

If you would like further information on Pharmaceutical Product Registration in Vietnam, please either email to our Partners at: info@sblaw.vn or call to our Office:

Ha Noi Office: +84 (4) 62 62 0246

HCM Office: +84 (8) 35 208 101.