In which cases shall drugs be supplemented or replaced with Vietnamese-language patient information leaflets after customs clearance from January 15, 2024 in Vietnam?

In which cases shall drugs be supplemented or replaced with Vietnamese-language patient information leaflets after customs clearance from January 15, 2024 in Vietnam?

On November 30, 2023, the Minister of Health issued Circular 23/2023/TT-BYT amending and supplementing some articles of Circular 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health on labeling of drugs, excipients, and patient information leaflets (PILs).

From January 15, 2024, drugs may be supplemented or replaced with Vietnamese-language PILs after customs clearance in the following cases:

- Imported drugs that have a registration certificate for circulation in Vietnam that have a Vietnamese-language PIL on the commercial packaging but have not yet updated the contents of the PIL according to the requirements of the Ministry of Health

Except for drugs that do not require a PIL as specified at points a, b, c, and d of Clause 1, Article 13 of Circular 01/2018/TT-BYT.

- Imported drugs that do not have a registration certificate for circulation in Vietnam that do not have a Vietnamese-language PIL on the commercial packaging, except for drugs that do not require a PIL as specified at points a, b, c, d, and dd of Clause 1, Article 13 of Circular 01/2018/TT-BYT.

- Imported drugs that have been granted a registration certificate for circulation by the Ministry of Health in an emergency case for national defense, security, disease prevention and control, disaster relief, and disaster recovery that do not have a Vietnamese-language PIL on the commercial packaging.

In which cases shall drugs be supplemented or replaced with Vietnamese-language patient information leaflets after customs clearance from January 15, 2024 in Vietnam? - Source: Internet

What content are included in the information on package inserts in Vietnam?

Pursuant to Article 12 of the Circular 01/2018/TT-BYT stipulating the information on package inserts in Vietnam as follows:

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.

Which drugs' inserts shall be kept its original language in Vietnam?

Pursuant to Article 13 of the Circular 01/2018/TT-BYT stipulating requirements of a package insert as follows:

Requirements of a package insert

1. Every drug sold on the market, or produced or prepared by a health facility as regulated in Clause 1 Article 11 herein, must have a package insert written in Vietnamese language, except for the following cases:

a) 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;

b) Drugs prepared and retailed at drugstores in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy;

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

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

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

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Therefore, the original insert in a foreign language must be retained in the case of imported drugs used for emergency and antidote purposes that do not have the same active ingredient and route of administration as the drugs currently in circulation in Vietnam.

Note: Circular 23/2023/TT-BYT takes effect from 15/01/2024.

Best regards!