Vietnam Updates Pharmaceutical Product Labeling Regulations

Vietnam’s Ministry of Health introduced new amendments to pharmaceutical products labeling and packaging regulations, effective starting January 15, 2024. On November 30, 2023, Vietnam’s Ministry of Health (MoH) issued Circular 23/2023/TT-BYT (hereinafter referred to as ‘the new Circular’). The new Circular brings forth amendments to the existing regulations governing the labeling of pharmaceutical products, providing updates to the provisions established by the previous Circular No. 01/2018/TT-BYT, dated January 18, 2018. Scheduled to become effective on January 15, 2024, the new Circular offers a transitional period allowing drugs or pharmaceutical materials manufactured or imported before January 01, 2025, to continue utilizing approved labels and package inserts until the respective batch’s expiration. For ongoing applications as of the circular’s effective date, adherence to existing regulations is permissible unless the registrant voluntarily opts to align with the updated requirements. However, it’s imperative to emphasize that strict compliance with the new Circular’s labeling and package insert specifications will be mandatory for drug introductions in Vietnam by January 01, 2025. In this article we look into the key details emerging from the new Circular, shedding light on the specific modifications introduced to labeling and packaging regulations in Vietnam’s pharmaceuticals industry.

Regulatory flexibility in packaging The amendments reflect an acknowledgment of the unique characteristics inherent in radioactive drugs. Unlike their conventional counterparts, these pharmaceuticals come with inherent risks and complexities that require a specialized regulatory approach. Thus, recognizing that traditional packaging norms may not align with the nature of these substances, Clause 3 Article 3 states that labels and package inserts of radioactive drugs can be “accompanied with drug delivery records sent to treatment facilities or stuck or affixed to packages used for storage or transport of drugs.”

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Clause 4 specifies regulatory flexibility for imported drugs that have obtained marketing authorization for purposes related (but not limited) to: Epidemic prevention and control; or Disaster and calamity recovery. Acknowledging the critical role of these pharmaceuticals in emergency situations, the revised provisions permit them to affix their package inserts onto their secondary packaging.

Secondary labeling for imported pharmaceuticals

The updated regulations in Article 5 of the new Circular focus on improving the information completeness of imported drugs. By introducing secondary labeling for drugs lacking compulsory information, the regulatory framework aims to fill potential transparency gaps. After customs clearance, this initiative ensures that imported drugs include all necessary details, meeting regulatory standards and promoting increased transparency in the pharmaceutical supply chain.

Customs clearance and language adaptation The new Circular aims to simplify regulatory procedures by allowing easier customs clearance for adding or replacing package inserts in the Vietnamese language. This modification supports clearer communication, ensuring that pharmaceutical information is readily accessible to local stakeholders. Moreover, by meeting language requirements, these changes facilitate a smoother market entry for imported pharmaceuticals.

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Article 16 of the new Circular introduces a key amendment mandating the specification of active ingredients and concentrations in the smallest units. This aims at enhancing accuracy in conveying information about pharmaceutical composition, promoting safer usage. Guidelines for multi-dose liquid or semi-solid drugs Building on this, the amendments provide full guidelines for expressing content in multi-dose liquid or semi-solid drugs.

Article 29 brings about significant