Vietnam: What does the information specified in the label of a drug or medicinal ingredient being sold on the market include?

Vietnam: What does the information specified in the label of a drug or medicinal ingredient being sold on the market include? (Illustrative Image)

Article 61 of the Law on Pharmacy 2016 stipulates that the label of a drug or medicinal ingredient being sold on the market must have:

- Name of the drug or medicinal ingredient;

- Dosage form, except for medicinal ingredients;

- Composition, concentrations of active ingredients, herbal ingredients in the drug or medicinal ingredient; labels of traditional drugs on the list of State secrets and labels of hereditary remedy are allowed to omit certain herbal ingredients and concentrations and shall have the text “Công thức sản xuất thuốc là bí mật nhà nước” (“The formula is state secret”) or “Công thức sản xuất thuốc là bí mật gia truyền” (“The formula is hereditary secret”)

- Package contents;

- Name and address of the manufacturer;

- Name and address of the importer (for imported drugs and medicinal ingredients);

- Number of the certificate of marketing authorization or import license, batch number, date of manufacture;

- Expiry date of the drug/medicinal ingredient;

- Storage conditions and other necessary information as prescribed.

Note: The package insert is an integral part of the label and must contain every information as prescribed above in Vietnamese language, except for information that cannot be translated into Vietnamese.

The Minister of Health of Vietnam shall provide for contents of drug/medicinal ingredient labels, package inserts; changes to expiry dates on drug labels for reason of national defense and security, prevention and elimination of epidemics, or disaster recovery.

Details may be found in the Law on Pharmacy 2016 effective as of January 1, 2017.

Ty Na

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