No. : 08/2009/TT-BYT
Independence - Freedom - Happiness
Hanoi, July 01, 2009
Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Pharmacy Law No. No. 34/2005/QH11 dated June 14, 2005;
To ensure the safety for the drug users and create favorable conditions for the patients to buy drug to treat minor illnesses and common symptoms by themselves. The Ministry of Health issues and guides the implementation the "List of OTC drugs" as follows:
Article 1. Issuing together with this Circular the "List of OTC drugs", including:
1. List of pharmaceutical drugs;
2. List of drugs originated from medicinal herbs.
Article 2. Explanation of terms
1. OTC drugs are the drug dispensed, sold and used without prescription;
2. Prescription drugs are the drugs if not used in accordance with the prescriber’s indication, they may be dangerous to life or health; it is required to follow the prescription when dispensing, retailing and using these drugs for the outpatients;
Article 3. Principle to develop the “List of OTC drugs”
1. The list of OTC drugs is developed on the basis of specific criteria of pharmacological properties and safety of the drug.
2. The list of OTC drugs is developed in accordance with actual use and supply of drug of Vietnam and with the reference of classification of OTC drugs (Over The Counter) from a number of countries such as Australia, the USA, European countries, Philippines, Singapore and China;
3. The list of OTC is modified and supplemented annually. In case of necessity, in order to ensure the user’s safety, a number of types of drug may be removed from the list of OTC drugs if they have serious adverse effect detected;
Article 4. Criteria for selection of OTC drugs
Drugs simultaneously satisfy the following criteria shall be selected in the list of OTC drugs:
1. The drug has low toxicity, does not generate decomposition products with toxicity has no serious adverse effects (adverse effects are the consequences of death, danger to life and hospitalization is required for treatment or prolonged treatment, causing permanent or severe disability, birth defect, congenital malformation and equivalent consequences, ...) that have been known and / or warned work of these effects.
2. Drugs have wide range of dosage, safety for age groups, little effect on the diagnosis and treatment of diseases that should be monitored clinically.
3. Drugs are indicated for the treatment of common diseases and patients can treat themselves, unnecessary examination, consultation and monitoring from the physician.
4. Simple route and form of administration (mainly the oral and administration) with the content and concentration suitable for self-treatment.
5. Drugs have little interaction with other drugs and common food and beverage;
6. Drugs do not cause the drug dependence.
Article 5. Application of “List of OTC drug”
1. The list of OTC drugs is the basis for classification of OTC drugs and prescription drugs. The OTC drugs are permitted for dispensation, sale and use without prescription;
2. The list of OTC drugs is the legal grounds for the formulation and promulgation of regulations and guidelines for the OTC drugs in registration, production, import, export, circulation, distribution of drug, information of drug advertisements and scope of activities of drug retail establishments.
3. For drugs indicated as contraceptive pills that are classified as OTC drugs in this List, the medical officers shall guide the use of drug prior to dispensation or sale to consumers.
4. Other scopes of application of List of OTC drugs shall be guided in the relevant documents;
Article 6. Implementation organization
1. For drug retail establishments:
From the effective date of this Circular, the drug retail establishments are permitted to retail drugs without prescription for the drugs specified in the List of OTC drugs;
2. For drug production and trading establishments:
a) For dossiers to register drug circulation in Vietnam and dossier to import drug without registration number that have been submitted in the Drug Administration of Vietnam before the effective date of this Circular, the establishments must classify, modify and supplement documents related to the classification of drug under the provisions of this Circular before considering the issuance of registration number or import license;
b) For the drugs that already have their registration number or permitted for import before the effective date of this Circular:
- The drugs that are produced and imported within 12 months from the effective date of this Circular and put into circulation in the market shall be permitted for circulation to the their expiration;
- After 12 months from the effective date of this Circular, the establishments that must classify, update and supplement information on drug labels and drug facts related to the classification of drug under the provisions of this Circular shall be permitted for putting their drugs into circulation on the market;