The Turkish Pharmaceuticals and Medical Devices Agency (“Agency”) published the Communiqué on Manufacturing Sites of Dietary Foods for Special Medical Purposes in Official Gazette number 29474 on 13 September 2015 (“Communiqué”). The Communiqué outlines principles and procedures for sites which manufacture dietary foods for special medical purposes, including processes for licensing and Agency supervision.
Significant provisions in the Communiqué include:
- Dietary foods for special medical purposes (including those intended for export) can only be manufactured at sites which hold a manufacturing site license from the Agency. Annex I of the Communiqué lists the information and documents required during license applications. The Agency will verify the application information’s accuracy and grant licenses to qualifying applicants within 90 days. Agency supervisors will later carry out site inspections to determine whether the applicant’s manufacturing site meets the necessary licensing conditions (Article 5).
- License holders for manufacturing sites must (Article 6):
- Employ appropriate personnel for production, quality control, storage and distribution operations.
- Dispose of unusable products in accordance with legislation.
- Inform the Agency beforehand if the information and documents change from those which were presented during the initial license application.
- Immediately appoint a new responsible manager and inform the Agency if the current responsible manager resigns or cannot carry out his/her duties.
- Allow Agency supervisors to enter the necessary parts of the premises to conduct examinations. Supervisors must present their certificates of authorization during examinations.
- Provide all necessary opportunities for the responsible manager to carry out his/her duties.
- The manufacturing site holder must permanently appoint a responsible manager who meets the criteria specified under Article 7.
- The Agency must supervise licensed manufacturing sites within a set supervision framework, as well as in any other situation it considers necessary (Article 8).
- Manufacturing sites must operate in accordance with the “Good Manufacturing Practice Principles”, outlined in the Communiqué. These address personnel, equipment, premises, manufacturing, quality control, documentation and toll manufacturing (Article 9 and cont’d).
The Communiqué enters into effect on 13 September 2015 and is overseen by the Head of the Agency. For applications made before the Communiqué’s effective date, the relevant legislation in force at the application date will be applied.
Please see this link for the full text of the Communiqué (only available in Turkish).