Dicle Doğan and Fatma Sevde Tan, Gun + Partners
On 27 February 2020, the Turkish Medicines and Medical Devices Agency published Guidelines on the Import of Research Products to be used in Clinical Research (Turkish language). Pursuant to the Regulation on Clinical Research published in the Official Gazette dated 13 April 2013 and numbered 28617, permission from the agency is required for the manufacturing and import of products to be used in clinical research conducted in Turkey.
The Guidelines regulate fundamental principles to be applied for the import of research products, their storage, pro forma invoices and import permit applications. Import permit applications are filed with the agency with a cover letter and a filled application form. The amount of research product needed in the clinical research project should be calculated and written down in the relevant section of the application form.
Applications are evaluated within 15 working days from the date of application. If the import application is approved, an accrual is created to pay the required document fee.
The guidelines have been in force as of 26 February 2020.
First published by Practical Law, in 01.04.2020