Vietnam’s new regulations on labeling of drugs, medicinal ingredients

According to Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam, the secondary package label of drugs must contain the following compulsory information: the drug name; dosage form; the composition of the drugs, contents, weights or concentrations of active ingredients or herbal ingredients; package contents; indications, usage instructions and contraindications; registration number or import license number (if any); batch number, manufacturing date, expiry date, quality standards and storage conditions; precautions and recommendations; name and address of manufacturer; name and address of importer (for imported drugs); drug origin.

The secondary package label of medicinal ingredients (including herbal ingredients, traditional ingredients, semi-finished drugs and semi-finished herbal medicines) must contain the following compulsory information: name of medicinal ingredients; weight or volume of medicinal ingredients contained in a smallest package unit; quality standards of medicinal ingredients; registration number or import license number (if any); batch number, manufacturing date, expiry date and storage conditions; name and address of manufacturer of medicinal ingredients; name and address of importer (for imported medicinal ingredients); origin of medicinal ingredients.

The following texts must be specified on secondary labels of medicinal ingredients which are active ingredients, herbal ingredients or semi-finished drugs containing active ingredients or herbal ingredients on the Lists of narcotic active ingredients, psychotropic ingredients, drug precursors, toxic medicinal ingredients, toxic herbal ingredients and radioactive medicinal ingredients: “Nguyên liệu gây nghiện” (“Narcotic active ingredients”), “Nguyên liệu hướng thần” (“Psychotropic ingredients”), “Nguyên liệu tiền chất làm thuốc” (“Drug precursors"), “Nguyên liệu độc” (“Toxic medicinal ingredients”), “Dược liệu độc” (“Toxic herbal ingredients”) or “Nguyên liệu phóng xạ” (“Radioactive medicinal ingredients”).

Moreover, Circular No. 01/2018/TT-BYT also provides clear regulations on the package inserts to assist patients in using medication effectively and safely.

Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam consists of 4 chapters, 40 articles and  takes effect from June 01, 2018.

Source: Thoi bao Tai chinh Viet Nam Online

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE