Pharmaceutical Marketing Authorization / Visa Number / Registration Number Extension in Vietnam

The Marketing Authorization (MA) is the official license issued by a competent authority that allows a pharmaceutical product to be legally marketed in Vietnam. The registration number — often referred to as the Visa No. or Reg. no — is a unique code granted as part of this MA to identify the product nationwide.
This article provides a detailed guide on how to apply for an extension or reissuance of the registration number under Circular 08/2022/TT-BYT and 55/2024/TT-BYT issued by the Ministry of Health.

1. What is the validity of a Marketing Authorization (MA) in Vietnam?

According to Circular 08/2022/TT-BYT (amended by Circular 55/2024/TT-BYT):

• 5 years since the date of MA approval or extension except specific cases as regulation:
• 3 years since the date of MA approval or extension in the below cases:
  • First-time MA for new drugs, reference biologics, biosimilars, or vaccines;
  • Products with the same API, strength or concentration and dosage form as a new drug not yet granted a 5-year MA;
  • Cases requiring continued safety and efficacy monitoring as recommended by the Advisory Council.;
  • Extension (renewal) applications lacking sufficient post-marketing safety data.

2. When to submit the MA extension application?

• Submit the application within 12 months before the MA expiry date.
• If the Drug Administration of Vietnam (DAV) accepts the dossier on time, the MA remains temporarily valid until an official extension (or renewal) decision is made.

3. Required documents for MA extension in Vietnam

• Application Form (Form 5B/TT);
• Valid Certificate of Pharmaceutical Product (CPP) for imported drugs;
• Safety & Efficacy Report (Form 2D/TT) — only required for:
  • MAs valid for 3 years;
  • Products previously recalled due to quality issues;
  • Products with serious adverse events during circulation.

Note: Changes to administrative information such as MA holder’s name / address or manufacturer’s name / address must be submitted separately according to regulations. The product name changes can be declared directly in the application.

4. Procedure for Marketing Authorization Extension

• • Submit the dossier via the DAV’s online system.
  • The Drug Administration of Vietnam (DAV) will conduct internal review or refer the case to the Advisory Council specifically.

5. Post-extension obligations

• • • Approved administrative changes must be implemented within 12 months since the date of extension approval.
    • Each drug can be issued only:
      • One MA under a brand name;
      • One MA under the International Nonproprietary Name (INN);

      unless the product is contract-manufactured or export-only.

6. Registration number structure in Vietnam

Since 2023, Reg. No. / Visa No. for pharmaceuticals in Vietnam follow a standardized 12-digit format:

Component	Description
First 3 digits	Country code (e.g., 893 = Vietnam)
1 digit	Product type (1 = Chemical, 2 = Herbal, 3 = Vaccine)
1 digit	Prescription classification (1 = Rx, 0 = OTC)
1 digit	Controlled substance category (e.g., 4 = toxic drug)
4 digits	Issuance sequence number
Last 2 digits	Year of issuance

Example: Reg. No. 893110223123 → Vietnam manufacturer, chemical, Rx, non-controlled, issued in 2023.

🔗 Further Reading

• • • • • ✅ Imported Drug Registration in Vietnam – Full Guide
        • 🔗 Drug Administration of Vietnam (DAV)