Approved by the National Assembly on November 21, 2024, the updated pharmaceutical law is set to take effect from July 1, 2025. These amendments introduce comprehensive changes aimed at enhancing domestic pharmaceutical production, regulating pharmacy chains, expanding e-commerce opportunities.
For foreign pharmaceutical companies, the law brings greater operational flexibility, clarifying their ability to purchase and distribute drugs produced via technology transfer, and expanding their rights in logistics and transportation—an area that was previously subject to legal uncertainty.
Key Anticipated Changes Impacting Foreign-Invested Enterprises (FIEs)
- Manufacturer Flexibility: Eases regulations on changing the actual manufacturer of finished drug products, supporting supply chain adjustments.
- Marketing Authorization: Proposes a single, long-term marketing authorization for a product’s lifecycle, reducing administrative burden.
- USFDA GMP Recognition: Moves toward officially recognizing USFDA-certified manufacturers that have a confirmed Good Manufacturing Practice (GMP) status or Certificate of Pharmaceutical Product (CPP).
- Expanded Rights for FIEs:
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- Repurchase and sell drugs made via technology transfer in Vietnam.
- Import raw materials for use in outsourced or tech transfer production.
- Transport imported/processed drugs to various distribution points and facilities.
- Supply clinical trial drugs directly to research institutions.
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New Requirements & Ongoing Challenges
- Non-US Companies: Must continue to comply with Circular 08/2022/TT-BYT, including submission of CPPs from national authorities and possible GMP assessments.
- Compliance Obligations: Maintain drug quality, safety, efficacy, and fulfill operational requirements throughout the marketing authorization period.
- Local Representation: A local Representative Office is required; if the dossier isn’t signed by the Chief Representative, a Power of Attorney must be provided.
For more information, kindly refer to the link:
https://vanban.chinhphu.vn/?pageid=27160&docid=212466&classid=1&typegroupid=3