5 criteria to identify non-prescription drugs

The Ministry of Health clearly states 5 criteria for determining non-prescription drugs.

The Circular clearly states the principles of classifying non-prescription drugs: Ensuring safety for users; ensuring timely access to drugs for people; consistent with the reality of drug use and supply in Vietnam; in harmony with the principles and regulations of classifying non-prescription drugs of countries in the region and around the world .

Criteria for determining non-prescription drugs

According to the Circular, a drug is classified as a non-prescription drug if it meets all of the following criteria:

1- The drug must be proven to be safe and effective in preventing, alleviating or treating diseases; have a wide safety margin to ensure the health of the user; have low toxicity, during storage and when entering the human body do not create toxic decomposition products, do not cause reproductive toxicity, genetic toxicity or cause cancer, have no unwanted effects that require supervision and monitoring by a doctor or medical staff when using the drug according to the instructions for use and do not interact with commonly used drugs or foods that can lead to serious adverse reactions;

2- The drug is indicated for short-term treatment of diseases that patients can self-treat, without necessarily requiring a prescription and monitoring by medical staff;

3- The drug is less likely to cause dependence; less likely to be abused or misused, affecting the safety of the user; does not conceal serious illnesses, leading to delays in diagnosis and treatment;

4- The drug must have a simple dosage form and route of administration that the user can use by himself without the need for technical support or guidance from a doctor or medical staff; there are no special requirements regarding storage conditions or handling of the drug before and after use;

5- The ingredients do not contain medicinal herbs on the List of toxic medicinal herbs issued by the Ministry of Health.

Methods of classifying non-prescription drugs

The Circular clearly states that generic drugs are classified as non-prescription drugs according to the classification of original brand-name drugs that have been licensed for circulation in Vietnam.

Generic drugs are drugs with the same active ingredients, content, and dosage form as the original drug.

In case there is no original drug licensed for circulation in Vietnam, the drug is classified as a non-prescription drug according to the classification of drugs with the same active ingredients, medicinal materials, content, concentration, and dosage form as drugs licensed and circulated in countries with drug management agencies specified in Clause 9, Article 2 of this Circular (European Medicines Agency (EMA) and Stringent Regulatory Authorities (SRA).

Classified drugs are non-prescription drugs according to the classification of drugs with the same active ingredients, medicinal herbs, content, concentration, and dosage form that have been granted a circulation registration certificate in Vietnam if they meet the principles and criteria specified above.

Other cases are implemented according to the Council's opinion based on the principles and criteria specified above.

This Circular takes effect from July 1, 2025.

Wisdom

Source: https://baochinhphu.vn/5-tieu-chi-xac-dinh-thuoc-khong-ke-don-102250523143625654.htm