The Guideline on Applications for GMP Inspections of Overseas Manufacturing Facilities Has Been Updated

The Guideline on Applications for GMP Inspections of Overseas Manufacturing Facilities published by the Turkish Medicines and Medical Devices Agency has been updated and entered into force on 22 September 2025.

The Guideline on Applications for GMP (Good Manufacturing Practices) Inspections of Overseas Manufacturing Facilities (“Guideline”), published by the Turkish Medicines and Medical Devices Agency (“Agency”) has been updated and entered into force on 22 September 2025.

According to the announcement made on the Agency’s website, applications submitted before 24 September 2025 will be processed in accordance with the previous version of the Guideline. Applications submitted on or after 24 September 2025 will be evaluated in line with the updated version of the Guideline.

As of 01 March 2010, GMP inspection has been a requirement for products manufactured abroad and imported into Türkiye. Marketing authorization holders of human medicinal products authorized before this date must apply for a GMP inspection. Within this scope, due to the inability to conduct on-site inspections for products that obtained marketing authorization before 2010, it has been decided that an exceptional evaluation will be made based on the documentation for these products:

• For facilities that have previously been inspected and found compliant by Agency: an application must be submitted under Section B of the Guideline.
• For facilities that have not been previously inspected by TİTCK and for which an on-site inspection application has been submitted: provided that an application is made by 31 December 2025, a one-time exceptional evaluation based on documentation will be made without requiring a decision from the Priority Evaluation Board as stipulated in the Guideline. For this evaluation, an up-to-date inspection report and other documents specified in the Guideline must be submitted.

Within this scope, on-site inspection applications for products that obtained the marketing authorization before 2010 for which a documentation-based inspection application has not been submitted will be deemed invalid.

The full text of the Agency’s announcement and  the updated Guideline (only available in Turkish) can be accessed via this link.