Amendment to the Regulation on Licensing Traditional Herbal Medicinal Products
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The regulation narrows and clarifies the licensing framework for traditional herbal medicinal products in Turkey. Medical herbal teas and aromatherapeutic products are moved out of this regulation’s scope, while definitions for active substances, traditional herbal medicinal products, priority review, benefit-risk assessment, and endemic plant-based applications are updated or added. Pharmaceutical companies, herbal product manufacturers, importers, and regulatory teams should review whether their products still fall under this licensing route. Businesses working with endemic Turkish plants or products seeking faster market access may need to prepare applications under the revised definitions and priority review approach.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Removes medical herbal teas and aromatherapeutic products from the scope of this licensing regulation.
- Updates key definitions, including active substance, traditional herbal medicinal product, priority review board, and benefit-risk balance.
- Adds a specific definition for licensing applications involving herbal drugs or preparations obtained from endemic plants.
Obligations
What this law requires
Do not treat medical herbal teas or aromatherapeutic products as falling within the licensing scope of the Traditional Herbal Medicinal Products Licensing Regulation; these products are expressly excluded from this regulation’s scope.
When seeking licensing as a traditional herbal medicinal product, ensure the product has an indication compatible with traditional use and that traditional use is bibliographically proven, scientifically accepted by the Institution, or proven through verifiable documents.
Ensure products submitted under the traditional herbal medicinal product licensing route are intended for external, oral, or inhalation use, consistent with the amended definition of traditional herbal medicinal product.
For licensing applications, identify the active substance as the herbal drug, herbal preparation, or mixture planned for production that provides the product’s pharmacological, immunological, or metabolic effect, or is used for medical diagnosis.