Information on package inserts in Vietnam

Information on package inserts in Vietnam (Internet image)

1. What is package insert?

According to Clause 2, Article 3 of Circular 01/2018/TT-BYT, the package insert is an integral part of the drug label and contained in the secondary package. If a drug does not have the secondary package, the package insert must be printed or affixed on the primary package.

2. Information on package inserts

According to Article 12 of Circular 01/2018/TT-BYT, the package insert of drugs must contain the compulsory information below:

- The drug name.

- Precautions and recommendations.

- Composition of the drug.

- Dosage form.

- Indications.

- Usage instructions and dose.

- Contraindications.

- Warnings and cautions.

- Warnings for the use of drugs during pregnancy and breastfeeding.

- Influence of the drug on ability to drive or operate machinery.

- Drug interactions and incompatibilities.

- Adverse drug reactions.

- Overdose and treatment.

- Information about pharmacodynamics (not applicable to OTC drugs, herbal drugs and traditional drugs).

- Information about pharmacokinetics (not applicable to OTC drugs, herbal drugs and traditional drugs).

- Package contents.

- Storage conditions, expiry date and quality standards.

- Name and address of manufacturer.

3. Requirements of a package insert in Vietnam

According to Article 13 of Circular 01/2018/TT-BYT, requirements of a package insert as follows:

- Every drug sold on the market, or produced or prepared by a health facility as regulated in Clause 1 Article 11 of Circular 01/2018/TT-BYT, must have a package insert written in Vietnamese language, except for the following cases:

+ Drugs produced or prepared according to traditional remedies or prescriptions as regulated in Clause 1 Article 70 and Clause 2 Article 85 of the Law on Pharmacy for use or retail according to prescriptions at health facilities;

++  A health facility applying traditional medicine may prepare, use, and retail traditional drugs within the facility.

++ Health facilities are permitted to produce and prepare drugs to serve their need for treatment when the conditions specified by the Ministry of Health are fully satisfied.

+ Drugs prepared and retailed at drugstores in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy; Purchase medicinal ingredients to prepare prescription drugs and sell them. The chief pharmacist of the drugstore shall manage preparation of drugs therein;

+ Drugs which have been not yet granted the Certificate of registration in Vietnam but are imported to serve the purpose of bioequivalence study, bioavailability assessment, use as specimens for registration, testing or scientific research, or display at a fair or exhibition;

+ Drugs imported in accordance with regulations in Point b Clause 1 Article 68 of the Decree No. 54/2017/ND-CP;

The drug has not met the treatment needs and falls into one of the following cases:

++ Drugs used for emergency and anti-poison purposes; anti-rejection;

+ Drugs on the List of rare drugs;

++ Medicines included in the guidelines on prevention and treatment of anaphylaxis issued or approved by the Ministry of Health;

++ Drugs used for specific patients being treated at medical examination and treatment establishments for diagnosis, prevention or treatment of: group A infectious diseases, cancer, HIV/AIDS, tuberculosis , malaria; other fatal diseases decided by the Minister of Health.

+ OTC drugs having labels containing all compulsory information of the package insert as prescribed in Article 12 herein.

- Package inserts in foreign languages of the drugs mentioned in Point d Clause 1 of this Article must be kept unchanged.

- If multiple drugs share the same name, active ingredients, herbal ingredients, dosage form, administration route, indications and manufacturer but the volume, contents, concentrations, weights or package contents are different and all of them are permitted for free sale, they may be written on the same package insert.

If there are differences in concentrations or contents, it is required to specify the concentrations, contents, volumes or package contents.

- At least one package insert in Vietnamese language must be contained in the secondary package of drugs. If there is no secondary package, at least one package insert must be contained in the primary package of drugs.

Quoc Dat

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