Regulations on labels of drugs and medicinal ingredients being sold on the market in Vietnam

Regulations on free sale of drugs and medicinal ingredients in Vietnam

Pursuant to Article 59 of the Law on Pharmacy 2016, regulations on free sale of drugs and medicinal ingredients are as follows:

- The drugs/medicinal ingredients permitted for free sale include:

+ Drugs and medicinal ingredients granted certificates of free sale;

+ Imported drugs and medicinal ingredients specified in Clause 1 through 4 of Article 60 of the Law on Pharmacy 2016;

+ The drugs specified in Point b Clause 1 Article 47, Clause 1 and Clause 2 Article 70, and Clause 3 Article 85 of the Law on Pharmacy 2016;

+ Drugs and medicinal ingredients domestically manufactured may be sold sale until their expiry dates if they are manufactured before the expiry dates of certificates of free sale;

+ Imported drugs and medicinal ingredients may be sold until their expiry dates if they are delivered at the port of departure in the exporting country before the expiry dates of certificates of free sale;

+ Drugs or medicinal ingredients domestically manufactured or imported before the revocation date of the certificate of free sale as prescribed in Article 58 hereof, except for recalled drugs and medicinal ingredients specified in Article 62 of the Law on Pharmacy 2016.

- A drug must satisfy the following requirements to be sold on the market:

+ It meets quality standards and ensures safety and efficacy;

+ It complies with regulations on drug labeling in Article 61 hereof and relevant regulations of law;

+ The packaging material and method ensure drug quality.

- A medicinal ingredient must satisfy the following requirements to be sold on the market:

+ It is qualified for drug manufacture and ensures safety and efficacy;

+ It complies with regulations on drug labeling in Article 61 hereof and relevant regulations of law;

+ The packaging material and method ensure medicinal ingredient quality.

Regulations on labels of drugs and medicinal ingredients being sold on the market in Vietnam (Internet image) 

Regulations on labels of drugs and medicinal ingredients being sold on the market in Vietnam

Pursuant to Article 61 of the Law on Pharmacy 2016 regulations on drug labels and medicinal ingredients circulated on the market

- 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 free sale or import license, batch number, date of manufacture;

+ Expiry date of the drug/medicinal ingredient;

+ Storage conditions and other necessary information as prescribed.

- The package insert is an integral part of the label and must contain every information specified in Points a, b, c, d, đ, h, i of Clause 1 of Article 61 of the Law on Pharmacy 2016 in Vietnamese language, except for information that cannot be translated into Vietnamese.

- The Minister of Health 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.

Mai Thanh Loi

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