The Guidance on Import Applications and Releases to the Market (“Guidance”) has been published on the Turkish Medicines and Medical Devices Agency’s website on 29 August 2022 and entered into force on the same day.
The Guidance regulates topics regarding the import application conditions and required documents for the applications of non-controlled human medicinal products, blood product or human medicinal products containing blood product, immunological human medicinal products, traditional herbal medicinal products, products with intermediate product permit document, radiopharmaceuticals with the registration certificate, allergen products and raw materials as well as the procedures and merits to be followed in the relevant applications.
Within this framework, the relevant Guidance provisions have become effective as of 29 August 2022.
You can access the Guidance from the link below (only in Turkish):