Recent development
The Turkish Medicines and Medical Devices Agency (the “TİTCK“) announced that license applications for human tissue and cell products must be completed by December 15, 2016.
Pre-registrations for such products on the Medical Devices and Drugs Databank (the “TİTUBB“) will be invalid if the license applications are not completed by this date.
Background
On March 31, 2016, the TİTCK announced its intention to make newly developed human tissue and cell products available in the Turkish market for both patients and clinicians. The TİTCK will accept pre-registrations for human tissue and cell products through the TİTUBB until August 15, 2016.
The pre-registrations conducted through the TİTUBB are currently under the assessment phase.
Conclusion
Applicants for human tissue and cell products should not miss the December 15, 2016 deadline and should follow the announcements made on the TİTCK’s website.
