Circular No. 23/2014/TT-BYT Issuing the List of Over-the-Counter Medicines

CIRCULAR

Issuing the List of Over-the-Counter Drugs

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Pursuant to the Medicine Law No. 34/2005-QH-11 dated June 14, 2005;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

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 the Circular on the List of Over-the-Counter Medicines.

Article 1. Attached to this Circular is the "List of Over-the-Counter Medicines," including:

1. List of chemical medicines.

2. List of traditional medicines and medicines derived from medicinal herbs.

Article 2. Interpretation of Terms

1. Over-the-counter medicine is medicine that can be dispensed, sold, and used without a prescription.

2. Prescription medicine is medicine whose improper use according to the prescriber's instructions may endanger life and health; when dispensing, retailing, and using for outpatients, it must be done based on a prescription.

Article 3. Principles for compiling the "List of Over-the-Counter Medicines"

1. The list of over-the-counter medicines is compiled based on specific criteria regarding the pharmacological properties and safety of the medicines.

2. The list of over-the-counter medicines is compiled in accordance with the actual usage and supply of medicines in Vietnam and takes into account the classification of over-the-counter medicines in other countries.

3. The list of over-the-counter medicines will be revised and supplemented to meet the actual usage and supply of medicines. In necessary cases, to ensure user safety, certain types of medicines may be removed from the list of over-the-counter medicines if serious adverse effects are discovered.

Article 4. Criteria for selecting over-the-counter medicines

Medicines meeting all of the following criteria shall be selected for inclusion in the List of Over-the-Counter Medicines:

1. Medicines have low toxicity, do not produce toxic decomposition products during storage or upon entering the human body, and do not cause severe adverse effects (effects causing death, endangering life, requiring hospitalization for treatment or prolonging treatment time, causing permanent or severe disability, congenital malformations, and similar consequences) known or warned about.

2. Medicines have a wide dosage range, are safe for different age groups, and have minimal impact on the diagnosis and treatment of diseases requiring clinical observation.

3. Medicines are prescribed for treating common illnesses and patients can self-treat without necessarily needing medical consultation, advice, and follow-up.

4. Routes and forms of administration are simple (mainly oral and topical) with appropriate concentrations suitable for self-treatment.

5. Medicines have little interaction with other commonly used drugs and food and beverages.

6. Medicines do not cause dependence.

Article 5. Implementation of the "List of Over-the-Counter Medicines"

1. The list of over-the-counter medicines serves as the basis for classifying over-the-counter and prescription medicines.

2. The list of over-the-counter medicines provides the legal foundation for establishing and issuing regulations and guidelines for over-the-counter medicines in drug registration, production, export, import, circulation and distribution, advertising information, and the scope of activities of retail pharmacies.

3. For contraceptive medicines classified as over-the-counter medicines in this list, healthcare personnel must provide guidance on their use before dispensing, distributing, or selling them to consumers.

Article 6. Implementation Organization

1. For retail pharmacies From the date this Circular takes effect, retail establishments are permitted to sell over-the-counter medicines listed in this Circular without prescriptions.

2. For pharmaceutical manufacturing and trading enterprises

a) For drug registration files submitted to the Drug Administration of Vietnam prior to the effective date of this Circular and for import files of unregistered drugs, enterprises must complete the classification, revision, and supplementation of relevant documents related to drug classification according to this Circular before obtaining registration numbers or import permits.

b) For drugs already registered for circulation or granted import permits prior to the effective date of this Circular, the following applies:

- Within twelve months from the effective date of this Circular, enterprises are allowed to produce, import, and place on the market drugs with labels and classifications as previously approved until their expiration dates.

- After twelve months from the effective date of this Circular, enterprises must classify, update, and supplement information on labels and patient information leaflets related to drug classification according to this Circular before placing the drugs on the market.

3. The Drug Administration, units under the Ministry of Health, provincial and municipal health departments, Vietnam Pharmaceutical Corporation, pharmaceutical production and trading enterprises, and foreign companies licensed to operate in the pharmaceutical sector are responsible for implementing this Circular.

Article 7. Implementation Provisions

1. This Circular takes effect from August 15, 2014.

2. In case the referenced documents in this Circular are replaced or amended, they shall be implemented according to the replacement or amended documents.

3. Circular No. 08/2009/TT-BYT dated July 1, 2009 of the Minister of Health on the List of Over-the-Counter Medicines ceases to be effective from the date this Circular takes effect./.