Recent developments
The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently introduced and made available a new Electronic Value Transfer Notifications System for use of licensees and authorized persons for their value transfer notifications.
Background
The Regulation on the Promotion of Pharmaceutical Products for Human Use (the “Promotion Regulation”, available here in Turkish) requires any licensee and/or authorized person to notify the TİTCK of all value transfers made to healthcare professionals and health institutions and organizations that exceed the limits set out in the Promotion Regulation within the first six months of the following year.
In this context, The TİTCK established the Electronic Value Transfer Notifications System for the licensees or authorized persons within the scope of the Promotion Regulation to issue value transfer notifications. The licensees and authorized persons are also obligated to retain all information and documents related to the value transfer for five years.
Conclusion
The new Electronic Value Transfer Notifications System is now available for use to facilitate the value transfer notification process for pharmaceutical companies within the scope of the Promotion Regulation. Pharmaceutical companies should therefore take note of the new procedural steps for the value transfer notifications and carefully review the new Electronic Value Transfer Notifications System.
