The Ministry of Health has just issued a Circular regulating the registration of drug circulation and pharmaceutical ingredients, which details and guides the implementation of a number of articles of the 2016 Pharmacy Law and the Law amending and supplementing a number of articles of the 2024 Pharmacy Law, including regulations on non-prescription drugs.
Circular 12/2025/TT-BYT stipulates clinical data to ensure safety and effectiveness in drug registration dossiers and criteria to determine cases of exemption from trial, exemption from certain clinical drug testing stages in Vietnam and drugs that require phase 4 clinical testing in Clause 4, Article 89 of the Pharmacy Law.
In particular, the circular stipulates the documents and procedures for granting, renewing, changing, supplementing, and revoking the registration certificate for circulation of pharmaceuticals, vaccines, biological products, medicinal herbs, and drug ingredients for use in Vietnam in Clause 9, Article 56 and Clause 2, Article 58 of the Pharmacy Law;
Regulations on principles and criteria for classifying non-prescription drugs in Clause 27, Article 2 of the Pharmacy Law;
Regulations on reporting the safety and effectiveness of drugs after being granted a circulation registration certificate to carry out pharmacovard activities as prescribed in Clause 2, Article 78 of the Pharmacy Law;
Principles of organization and operation of the appraisal council, unit, and expert appraisal.
The Ministry of Health stated that this Circular does not regulate the registration dossier for traditional medicine; the dossier for registration of drug ingredients is traditional medicine and flavor.
Regarding non-prescription drugs, Article 15 of Circular No. 12 stipulates the principles, criteria, and methods for classifying non-prescription drugs. Accordingly, the principle of classifying non-prescription drugs must meet the following criteria: Ensuring safety for users; Creating conditions for timely access to drugs for people; Compatible with the actual use and supply of drugs in Vietnam; Approaching international standards and regulations of countries in the region.
Regarding the method of classifying non-prescription drugs, Circular No. 12 clearly states as follows:
According to the original farm: If the original farm licensed in Vietnam is not a prescription, then generic drugs are also classified similarly.
Abroad: If there is no original drug, drugs will be classified according to drugs licensed in countries with reputable drug management agencies.
According to drugs and active ingredients registered in Vietnam, if they fully meet the above criteria.
Special cases: Decided by the Professional Council based on the principles and criteria of the Circular.
