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 delve 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
Radioactive drugs
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.”
Emergency drugs
Clause 4 specifies regulatory flexibility for imported drugs that have obtained marketing authorization for purposes related (but not limited) to:
- National defense and security;
- 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.
Labels information compliance
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.
Ingredients and composition
Article 16 of the new Circular introduces a crucial 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 comprehensive guidelines for expressing content in multi-dose liquid or semi-solid drugs. This step promotes standardized practices and clarity in presenting information about drug content.
Article 29 brings about significant changes, notably:
- The requirement for information on the manufacturing date, expiry date, and batch number, originally in a foreign language on the original label, is now replaced with Vietnamese language. This ensures that the information is presented in the local language for better understanding.
- Clear guidance is provided on the lifespan of certain drugs after opening the primary package. This applies to products like eye drops, nose drops, ear drops, ointment, gel, and orally administered multi-dose liquid drugs.
Inclusion of barcodes and QR codes
Embracing technological advancements, Article 35 facilitates the integration of barcodes, QR codes, DataMatrix Codes, or other relevant codes into labels.
This aligns with the MoH’s roadmap for electronic instructions and labeling, contributing to the heightened traceability and efficiency of pharmaceutical products.
Ensuring information currency
Article 38 establishes a requirement for consistent updates for generic drugs, aligning their standards with those of original brand-name drugs. This commitment ensures that generic medications stay current and in compliance with evolving standards.
To further streamline this process, the new Circular delineates specific timelines for registrants and manufacturers of generic drugs to review and update information on labels and package inserts. This timeline spans 12 months from the date when the Drug Administration of Vietnam announces and publishes package inserts of original brand-name drugs on its website.
It's noteworthy that registrants and manufacturers are empowered to initiate these updates without notifying the MoH, unless explicitly requested by the Ministry.
Conclusion
Actively understanding and following new regulations on drug and pharmaceutical labeling in Vietnam is crucial to ensure compliance with evolving standards, fostering transparency and trust in the pharmaceutical supply chain.
Staying abreast of regulatory changes also facilitates seamless market entry, minimizing risks and enhancing the overall effectiveness of pharmaceutical operations in the dynamic Vietnam’s market.
