The Turkish Medicines and Medical Devices Agency (“TİTCK“) recently published on its website the draft Regulation on Authorization of Traditional Herbal Medicinal Products (“Regulation“). Within the scope of harmonization with EU legislation, the Regulation is based on the EU Directives No. 2001/83/EC and 2004/24/EC.
The Regulation sets out the procedures and principles for the authorization, packaging and distribution of medical herbal products. The Regulation aims to increase the efficiency and reliability of these products and ensure that they meet the required quality standards.
Products that do not comply with the Regulation will not be authorized and therefore will not be placed into the market. The Regulation lists the required documents and sets out the procedure for the authorization process. The Regulation clarifies the evaluation process and the objection mechanisms concerning the evaluation process in detail.
The Regulation also introduces certain requirements for the packaging of herbal medicinal products. Medical herbal products must contain usage instructions prepared in line with the requirements under the Regulation.
The draft Regulation on Authorization of Traditional Herbal Medical Products is available here (in Turkish).
The TİTCK continues to provide guidelines for companies in the healthcare sector in line with EU regulations. Companies under the scope of the Regulation should follow the authorization, packaging and distribution requirements set forth under the draft Regulation before introducing their products to the market.