Vietnam’s Circular No. 01/2018/TT-BYT: Information on package inserts

08:58, 06/06/2018

On January 18, 2018, the Ministry of Health of Vietnam issued Circular No. 01/2018/TT-BYT on labeling of drugs, medicinal ingredients and package insert. One of the fundamental contents of this Circular is the regulation on information on package inserts.

Specifically, according to Article 12 of Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam, the package insert of drugs must contain the compulsory information below:

First, the drug name.

Second, precautions and recommendations.

Third, composition of the drug.

Fourth, dosage form.

Fifth, indications.

Sixth, usage instructions and dose.

Seventh, contraindications.

Eighth, warnings and cautions.

Ninth, warnings for the use of drugs during pregnancy and breastfeeding.

Tenth, influence of the drug on ability to drive or operate machinery.

Eleventh, drug interactions and incompatibilities.

Twelfth, adverse drug reactions.

Thirteenth, overdose and treatment.

Fourteenth, information about pharmacodynamics (not applicable to OTC drugs, herbal drugs and traditional drugs).

Fifteenth, information about pharmacokinetics (not applicable to OTC drugs, herbal drugs and traditional drugs).

Sixteenth, package contents.

Seventeenth, storage conditions, expiry date and quality standards.

Eighteenth, name and address of manufacturer.

More details can be found in Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam, which takes effect from June 01, 2018.

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