Thailand’s Ministry of Public Health (MOPH) recently issued Order No. 1881/2024, marking an important development for organizations dealing with Category 1 narcotics — substances under the country’s most stringent regulatory controls.
This order authorizes the Secretary-General of the Food and Drug Administration (FDA) to sign licenses related to the production, import, export, sale, or possession of Category 1 narcotics on behalf of the Minister of Public Health.
Why Was This Change Introduced?
Previously, such licensing required direct ministerial approval, often leading to procedural delays. The new delegation of authority aims to:
- Streamline administrative processes within the FDA.
- Reduce approval timelines for legitimate narcotics-related activities.
- Enhance regulatory efficiency and support transparent governance under the Minister’s supervision.
Who Does This Affect?
This update is especially relevant for:
- Pharmaceutical manufacturers producing or formulating Category 1 narcotics for medical use.
- Importers and distributors handling controlled substances.
- Research organizations working with narcotic ingredients.
While the change simplifies authorization routes, it also reinforces the importance of strict regulatory compliance with Thai narcotics laws, documentation standards, and Good Distribution Practice (GDP) requirements.
Partner with Freyr for Controlled Substance Compliance in Thailand
At Freyr Solutions, our Regulatory Affairs experts help pharmaceutical and research organizations navigate the complexities of narcotics licensing and controlled substance compliance in Thailand. From documentation preparation to communication with the Thai FDA, we ensure you meet every regulatory requirement — efficiently and compliantly.
Connect with Freyr Solutions to simplify your Category 1 narcotics licensing process and stay fully aligned with MOPH Order No. 1881/2024.
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