Circular No. 07/2017/TT-BYT on the List of Over-the-Counter Drugs

CIRCULAR

Issuing the List of Over-the-Counter Drugs

Pursuant to the Medicine Law dated April 6, 2016;

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department,

The Minister of Health issues this Circular on the issuance of the List of Over-the-Counter Drugs”.

Article 1. Scope of Regulation

This Circular stipulates the principles for building and criteria for selecting over-the-counter drugs; the List of Over-the-Counter Drugs; the purpose of issuance and responsibilities for implementation.

Article 2. Principles for Building and Criteria for Selecting Over-the-Counter Drugs

1. Principles for Building the List of Over-the-Counter Drugs:

a) Ensuring safety for users;

b) Ensuring timely access to drugs for the public;

c) Being consistent with the actual drug usage and supply situation in Vietnam;

d) Harmonizing with the principles and regulations on classifying over-the-counter drugs in countries within the region and worldwide.

2. Criteria for Selecting Drugs for the List of Over-the-Counter Drugs

A drug will be considered for selection into the List of Over-the-Counter Drugs if it meets the following criteria:

a) Having low toxicity, not producing harmful decomposition products during storage or upon entering the human body, and not causing serious adverse reactions known or warned about by the World Health Organization, competent authorities in Vietnam or abroad that could lead to the following consequences:

- Death;

- Threatening life;

- Requiring hospitalization or extending hospital stay;

- Leaving severe or permanent sequelae;

- Causing congenital malformations in fetuses;

- Any other serious clinical adverse reactions assessed and determined by medical practitioners.

b) Having a wide dosage range, safe for all age groups, and having minimal impact on the diagnosis and treatment of diseases requiring clinical monitoring;

c) Being indicated for treating non-serious conditions where patients can self-treat without necessarily requiring a prescription or follow-up by medical practitioners;

d) Being available in simple routes of administration and forms (mainly oral and topical) with appropriate concentrations for self-treatment;

đ) Having minimal interactions with other drugs and common foods and beverages;

e) Having minimal potential for dependence;

g) Having minimal risk of misuse or inappropriate use affecting user safety;

h) Having been marketed in Vietnam for at least five years.

Article 3. List of Over-the-Counter Drugs

The over-the-counter drugs specified in the accompanying List of this Circular.

Article 4. Purpose of Issuing the List of Over-the-Counter Drugs

1. The List of Over-the-Counter Drugs serves as a basis for classifying over-the-counter and prescription drugs. Drugs not included in the List of Over-the-Counter Drugs are classified as prescription drugs.

2. The List of Over-the-Counter Drugs serves as a basis for state management agencies to develop and issue regulations and guidelines for over-the-counter drugs concerning registration, production, export, import, circulation and distribution, advertising, inspection, supervision, handling of violations, and other related activities.

Article 5. Effective Date

1. This Circular takes effect from July 1, 2017.

2. Circular No. 23/2014/TT-BYT dated June 30, 2014 of the Minister of Health issuing the List of Over-the-Counter Drugs ceases to be effective from the date this Circular takes effect.

Article 6. Transitional Provisions

1. From the date this Circular takes effect, drugs listed in the accompanying List of Over-the-Counter Drugs may be dispensed, sold retail, and used without a prescription, except for drugs currently classified as prescription drugs on their labels (including the drug usage instructions) which must be dispensed, sold retail, and used according to a prescription.

2. For drugs already registered for circulation in Vietnam or granted import permits before the date this Circular takes effect, the following applies:

a) For drugs listed in the List of Over-the-Counter Drugs under Circular No. 23/2014/TT-BYT but not included in the accompanying List of Over-the-Counter Drugs of this Circular, the entities named on the drug circulation registration certificates and importers must classify, update, and supplement information related to drug classification according to this Circular on the drug labels and usage instructions in accordance with the timeline set out in the Circular on Drug Labeling issued by the Minister of Health before putting the drugs on the market.

b) For drugs not listed in the List of Over-the-Counter Drugs under Circular No. 23/2014/TT-BYT but included in the accompanying List of Over-the-Counter Drugs of this Circular, from the date this Circular takes effect, it is encouraged that the entities named on the drug circulation registration certificates and importers classify, update, and supplement information related to drug classification according to this Circular on the drug labels and usage instructions before putting the drugs on the market; or the entities are permitted to produce and import drugs with classification information on the labels and usage instructions as approved for circulation until the expiration date of the drugs.

3. For drug registration files in Vietnam and import files for drugs without circulation registration certificates in Vietnam submitted to the Drug Administration before the date this Circular takes effect but have not yet received circulation registration certificates or import permits, the following applies:

a) For drugs listed in the List of Over-the-Counter Drugs under Circular No. 23/2014/TT-BYT but not included in the accompanying List of Over-the-Counter Drugs of this Circular, they must be classified according to this Circular;

b) For drugs not listed in the List of Over-the-Counter Drugs under Circular No. 23/2014/TT-BYT but included in the accompanying List of Over-the-Counter Drugs of this Circular, the entities may continue to classify the drugs according to the submitted files or classify them according to this Circular.

Article 7. Responsibility for Implementation

1. Responsibilities of pharmaceutical establishments, medical examination and treatment facilities:

a) Implementing the provisions of this Circular;

b) Propose amendments and supplements to the List of Over-the-Counter Medicines to be appropriate to the actual situation, ensuring timely provision of medicines for disease prevention and treatment.

2. Responsibilities of the Drug Administration Department:

a) Take the lead and coordinate with relevant agencies in implementing this Circular;

b) Review the List of Over-the-Counter Medicines, excluding traditional non-prescription medicines, and report to the Minister of Health based on the proposals for amendment and supplementation from the units specified in Clause 1 of this Article or the conclusions of the Advisory Council for Drug Registration.

3. Responsibilities of the Traditional Medicine Management Department:

a) Coordinate with the Drug Management Department and other relevant agencies in implementing this Circular;

b) Review the List of Traditional Non-Prescription Medicines and report to the Minister of Health based on the proposals for amendment and supplementation from the units specified in Clause 1 of this Article or the conclusions of the Advisory Council for Drug Registration.

In the course of implementation, if there are any difficulties, it is requested that agencies, organizations, and individuals promptly reflect them to the Drug Management Department or the Traditional Medicine Management Department (for traditional medicines) for consideration and resolution./.