TMDA Released Guidance on the Import of Research Products to Be Used in Clinical Research

Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the principles and procedures for the import of products to be used in clinical research studies conducted in the country.

This guide is connected to the No. 4 dated 07.15.2018 Ministry, relevant, on the Organization of other institutions and organizations with related institutions and organizations Presidential Decree first paragraph of Article 508 (a) and (c) to bend; 22.12.2017 dated and 30278 numbered Official Ministry of Health Gazette Affiliates Services Unit of Duties Working Procedures and Principles Regarding the Regulation Article 9 the first paragraph of subparagraph (a) and 13.04.2013 dated and 28617 numbered Official Gazette ‘ also published in Medical and Biological Products Regulations on Clinical Trials are based on the provisions of Article 16 paragraph.

TMMDA Clinical Trials for use in clinical research allowed to be carried out through the Department covers the import of investigational products.

Basic Principles:

• Import applications in accordance with the relevant legislation, made by the sponsor or his authorized representative.
• Clinical Research Department research can be done by using reference to the import of products accredited to be used in the execution of clinical research in our country.
• Office of the Institution of applications to import medical devices belonging to the subject of research needs to be done.
• Institute for imports of products subject to control our research is required to obtain permission from the relevant ministry.
• Clinical Research Department then import purposes can be made through the Presidency of the permitted research. 
• Applicant has located that information presented in the application form associated to the investigational product is proper would have pledged to sign the relevant application form.
• Import of investigational products, distribution, storage, storage centers, documents related to consumption and disposal to be sent if requested by the Authority, be stored for as long as required with the aid of the relevant legislation by using the sponsor or his authorized representative.
• Research supporting the distribution of products, it is the principal investigator in charge of hiding in the centers.

After the realization of the import goods can be sent directly to research centers or research institution approved by the clinical research on storage of products used in research and document delivery services that permit you to have stored in warehouses or manufacturing facilities with a permit. Applications are evaluated within 15 working days from the date of application.