On August 07, 2026, Customs Sub-Department of Region II issued Official Letter No. 17372/HQKV2-NVHQ providing guidance on customs procedures for re-imported medicines for the purpose of quality assessment.
Details are as follows:
1. General Principles on Import License
The customs declarant is not required to submit an Import License or notification of specialized inspection results, unless otherwise provided by specialized management laws.
2. Classification by Circulation Status of the Medicine
a. Case 1: Medicines with a valid Marketing Authorization/Registration Certificate in Vietnam
Permitted to be imported without applying for an import license, except for medicines subject to special control.
b. Case 2: Medicines without a Marketing Authorization/Registration Certificate in Vietnam
An Import License is mandatorily required.
Only the licensed quantity may be imported for non-commercial purposes (such as bioequivalence testing, bioavailability assessment, registration samples, testing samples, scientific research, etc.).
c. Case 3: Medicines subject to special control
An export/import license is mandatorily required. The imported quantity must not exceed the prescribed limit.
Enterprises need to cross-check the active ingredients to apply the correct regulations, noting new legal milestones such as Circular 18/2026/TT-BYT (effective from 16/07/2026) and the transition from Decree 69/2018/ND-CP to Decree 292/2026/ND-CP effective from 05/09/2026.
3. Dossiers and Licensing Authority
a. Dossiers
Enterprises shall proactively cross-check dossiers and documents in accordance with Article 58.1.d, Article 58.2, Article 123.1, and Article 65 of Decree No. 163/2025/ND-CP for implementation.
b. Licensing Authority
Special attention should be paid to the roadmap for the transfer of import licensing authority, in order to submit dossiers to the correct receiving authority:
- Before 01/07/2027: The authority to receive dossiers and issue import licenses belongs to the Ministry of Health.
- From 01/07/2027 onward: This authority is fully transferred to the Provincial People’s Committee where the importing establishment’s head office is located, to receive dossiers and issue licenses. Import licenses issued by the Provincial People’s Committee shall be valid nationwide.
(According to Official Letter No. 17372/HQKV2-NVHQ dated August 07, 2026)
Related service: Customs clearance procedures