Under Circular No. 32/2026/TT-BYT on the marketing authorization of drugs and medicinal ingredients, what principles, criteria, and methods apply to the classification of over-the-counter drugs?
On July 29, 2026, the Minister of Health of Vietnam promulgated Circular No. 32/2026/TT-BYT on the marketing authorization of drugs and medicinal ingredients. Article 15 of Circular No. 32/2026/TT-BYT prescribes the following principles, criteria, and methods for classifying over-the-counter drugs:
(1) Principles for classifying over-the-counter drugs
- Ensuring safety for users;
- Ensuring people’s timely access to drugs;
- Conforming to the actual use and supply of drugs in Vietnam;
- Harmonizing with the principles and regulations on the classification of over-the-counter drugs adopted by countries in the region and around the world.
(2) Criteria for identifying over-the-counter drugs
A drug shall be classified as an over-the-counter drug if it satisfies all the following criteria:
- The drug has been demonstrated to be safe and effective in preventing, alleviating, or treating diseases; has a wide safety margin; has low toxicity; does not produce toxic degradation products during storage or after entering the human body; does not cause reproductive toxicity, genotoxicity, or carcinogenicity; does not cause adverse effects requiring supervision or monitoring by a physician or healthcare professional when self-administered in accordance with its package insert; and does not interact with commonly used drugs or foods in a manner that may result in serious adverse reactions;
- The drug is indicated for the short-term treatment of conditions that patients can self-treat without necessarily requiring a prescription or monitoring by a healthcare professional;
- The drug has a low potential to cause dependence and a low risk of abuse or misuse that may compromise user safety, and does not mask serious diseases in a manner that may delay their diagnosis and treatment;
- The drug has a simple dosage form and route of administration that allow users to administer it themselves without technical assistance or instructions from a physician or healthcare professional, and does not require special conditions for its storage or handling before or after use;
- The drug does not contain any medicinal material included in the List of Toxic Medicinal Materials promulgated by the Ministry of Health of Vietnam.
(3) Methods for classifying over-the-counter drugs
- A generic drug shall be classified as an over-the-counter drug according to the classification of the original brand-name drug authorized for marketing in Vietnam;
- Where no original brand-name drug has been authorized for marketing in Vietnam, a drug shall be classified as an over-the-counter drug according to the classification of a drug containing the same active ingredient or medicinal material and having the same strength, concentration, and dosage form that has been authorized for marketing in a country whose drug regulatory authority is specified in Clause 9 Article 2 of Circular No. 32/2026/TT-BYT;
- A drug shall be classified as an over-the-counter drug according to the classification of a drug containing the same active ingredient or medicinal material and having the same strength, concentration, and dosage form for which a marketing authorization certificate has been issued in Vietnam, provided that it satisfies the principles and criteria specified in Clauses 1 and 2 Article 15 of Circular No. 32/2026/TT-BYT;
- Other cases shall be handled according to the Council’s opinion on the basis of the principles and criteria specified in Clauses 1 and 2 Article 15 of Circular No. 32/2026/TT-BYT.
See more details in Circular No. 32/2026/TT-BYT on the marketing authorization of drugs and medicinal ingredients, which takes effect as of October 1, 2026.
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