Amendment made to the regulation on human medicinal product manufacturing facilities
The Turkish Medicines and Medical Devices Agency published, in the Official Gazette dated 21 October 2026, a regulation amending the Regulation on Human Medicinal Product Manufacturing Facilities. The amendment adds new definitions for aromatherapeutic products, traditional herbal medicinal products, products obtained from cannabis, special medical purpose foods and medicinal herbal teas, and includes these products in the regulation. It also allows those who have served as responsible physicians for at least two years in regional blood centers to take on the role of technical manager (mesul müdür) in facilities that manufacture blood and plasma products.
Who is affected?
Employees of human medicinal product manufacturing facilities, responsible physicians in regional blood centers who want to become technical managers, and companies that produce the relevant products.
What changes?
Previously the term 'denetçiler' (auditors) was used; now this term has been changed to 'müfettişler' (inspectors), and those serving in this capacity were permitted to take on technical manager roles at blood product facilities.