Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency
TİTCK · Turkey · europe
Turkey's Medicines and Medical Devices Agency — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have a documented historical clinical and traditional-medical role in the Ottoman and modern Turkish medical traditions, with contemporary recognition under traditional and complementary medicine pathways.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Turkey
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.titck.gov.tr
Relevant Regulation Codes
- Turkish Law on Pharmaceuticals and Pharmaceutical Preparations (Law No. 1262), as amended
- Turkish Regulation on Traditional and Complementary Medicine Practices (Geleneksel ve Tamamlayıcı Tıp Uygulamaları Yönetmeliği, 2014, as amended) — explicitly includes hirudotherapy (sülük tedavisi) within its scope
- Turkish Medical Devices Regulation aligned with EU MDR 2017/745
Prescriber Requirements
- Turkish Medical Association–licensed physician with a Ministry of Health Traditional and Complementary Medicine certificate may perform hirudotherapy as a specifically recognised modality under the 2014 regulation
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
TİTCK registration as applicable; Turkish-language labelling required by national law. Standard cold-chain conditions.
Import/Export Rules
TİTCK and Ministry of Agriculture and Forestry clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Social Security Institution (SGK) coverage depends on the procedure and setting; the 2014 Traditional and Complementary Medicine regulation does not by itself create universal SGK reimbursement; outpatient hirudotherapy is variably reimbursed depending on credentialing and setting.
Key Regulatory Documents
ASH Editorial Notes
Turkey is one of the few jurisdictions globally with an explicit national regulatory recognition of hirudotherapy as a named traditional and complementary medicine modality, under the 2014 regulation. The exact training, certification, and SGK reimbursement implications of this status have not been independently verified by ASH and should be confirmed with Turkish regulatory and professional counsel.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.