Imported Drug Registration in Vietnam under Circular 08/2022/TT-BYT
Imported drug registration in Vietnam is governed by Circular 08/2022/TT-BYT and related laws. This article offers a step-by-step overview of how to obtain marketing authorization for imported pharmaceutical products.
1. Legal Basis
The imported drug registration process in Vietnam is supported by below legal documents:
- Law on Pharmacy No. 105/2016/QH13 dated April 6, 2016
- Decree No. 54/2017/ND-CP dated May 8, 2017
- Decree No. 155/2018/ND-CP dated November 12, 2018 (which amends Decree No. 54/2017/ND-CP)
- Circular No. 08/2022/TT-BYT dated September 5, 2022
- Circular No. 55/2024/TT-BYT dated December 31, 2024 (which amends Circular 08/2022/TT-BYT)
2. Scope of Application
This procedure applies to imported drugs. It covers chemical drugs, herbal medicines, biological products, and vaccines. These products must be registered before being marketed in Vietnam.
3. Imported Drug Registration in Vietnam – Step-by-Step Guide
3.1. Conditions for the Marketing Authorization Holder (MAH)
The applicant must meet one of the following conditions:
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- A Vietnamese company with a valid pharmaceutical business license
- A pharmaceutical foreign company with a representative office legally established in Vietnam
3.2. Requirements for the Manufacturing Site
The Drug Administration of Vietnam (DAV) must assess the foreign manufacturing site for GMP compliance (on-dossier or on-site). This is required under Article 95 of Decree 54/2017/ND-CP.
Note: The GMP assessment must be submitted before or at the same time as the imported drug registration dossier.
For detailed guidance, please refer to our article on GMP Assessment for Foreign Pharmaceutical Manufacturers.
3.3. Preparation of the Registration Dossier
The registration dossier should include the following:
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- Administrative documents according to Vietnamese regulation
- Technical documents in ACTD or ICH-CTD format
- Real time and accelerated stability data under climatic zone IVb (30°C ± 2°C / 75% RH ± 5%)
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3.4. Submission via the Online System
Next, you must submit the dossier using DAV’s electronic portal. All files should be in PDF format and digitally signed by the MAH.
3.5. Follow-up and Response to Requests
After submission, the MAH must regularly track the review status. When additional documents are requested, MAH coordinate with manufacturer respond promptly.
3.6. Issuance of Marketing Authorization (MA)
Once the review is complete, DAV will issue the Marketing Authorization (MA). This document allows the product to be officially circulated in the Vietnamese market.
Registering imported drugs in Vietnam requires strict compliance with both legal and technical regulations. To improve the chance of success, applicants should plan early, prepare complete documentation, and be ready to respond promptly to regulatory requests.