Circular No. 08/2009/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 Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

To ensure safety for drug users while creating favorable conditions for patients to purchase over-the-counter drugs for self-treatment of minor illnesses and common symptoms, the Ministry of Health promulgates and guides the implementation of the "List of Over-The-Counter Drugs" as follows:

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

1. List of chemical drugs;

2. List of drugs 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 If used not in accordance with the prescription instructions, such drugs may be dangerous to life and health; when dispensing, retailing, or using for outpatients, they must be done according to 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 drugs is developed in line with the actual drug usage and supply situation in Vietnam and has referred to the classification of over-the-counter drugs (OTC) in some countries such as Australia, the United States, some European countries, the Philippines, Singapore, and China.

3. The list of over-the-counter drugs will be revised and supplemented annually. In cases where necessary, to ensure user safety, certain types of drugs may be removed from the list of over-the-counter drugs if serious harmful effects are discovered.

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

Drugs that meet the following criteria simultaneously shall be selected for inclusion in the List of Over-The-Counter Drugs:

1. Drugs have low toxicity, do not produce toxic breakdown products, and do not cause severe adverse effects (such as those causing death, endangering life, requiring hospitalization for treatment or prolonging treatment time, causing permanent or severe disability, congenital malformations, and similar consequences) known and/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. Drugs are prescribed for the treatment of common illnesses and patients can self-treat without necessarily needing medical consultation, advice, and follow-up by a physician.

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 Drugs"

1. The List of Over-The-Counter Drugs serves as the basis for classifying over-the-counter drugs and prescription drugs. Over-the-counter drugs are permitted to be dispensed, sold, and used without a prescription.

2. The List of Over-The-Counter Drugs provides the legal basis for establishing and promulgating regulations and guidelines for over-the-counter drugs in drug registration, production, export, import, circulation and distribution, advertising information, and the scope of operations of retail drug outlets.

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

4. Other scopes of application of the List of Over-The-Counter Drugs will be specifically guided in related documents.

Article 6. Implementation Organization

1. For retail drug outlets:

From the date this Circular takes effect, retail outlets are permitted to sell over-the-counter drugs without prescriptions for drugs listed in the List of Over-The-Counter Drugs.

2. For drug manufacturing and trading enterprises:

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

b) For drugs already registered for circulation or permitted for import before the effective date of this Circular:

- Drugs produced or imported within 12 months from the date this Circular takes effect and put into circulation on the market shall be allowed to circulate until the expiration date of the drugs.

- After 12 months from the date this Circular takes effect, enterprises must classify, update, and supplement information on labels and drug usage instructions related to the classification of drugs according to the provisions of this Circular before being allowed to put the drugs back into circulation on the market.

Article 7. Implementation Provisions

1. This Circular takes effect 45 days from the date of issuance.

2. The Drug Administration, units under the Ministry of Health, Provincial Departments of Health, Central City Departments of Health, Vietnam Pharmaceutical Corporation, pharmaceutical production and trading enterprises, and foreign companies licensed to operate in the pharmaceutical sector are responsible for implementing this Circular.

3. During the implementation process, if there are any issues, organizations and individuals are requested to promptly reflect them to the Ministry of Health (Drug Administration) for consideration and resolution./.