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Recent Development
On 7 May 2021, the Turkish Medicine and Medical Devices Authority (“TİTCK”) published a new announcement on the value transfers concerning donations to health institutions/organizations and scientific meetings and product promotion meetings that were postponed or canceled due to COVID-19 restrictions. The announcement is available here (in Turkish).
What’s New?
According to the Regulation on Promotion of Pharmaceuticals, license/authorization holders must notify the TİTCK of value transfers at a monetary value higher than 10% of the gross minimum wage to organizations/persons operating in the health sector. In this respect, the TİTCK provided explanations on the value transfers concerning fully/partially sponsored scientific meetings and product promotion meetings that were canceled or postponed due to COVID-19 measures, as well as donations to health organizations/institutions.
According to the TİTCK’s announcement, value transfer notifications must be made to the TİTCK as described below:
- The payments made to the healthcare professionals (e.g., registration, accommodation, transportation, etc.) for preapproved scientific meetings and product promotion meetings that were postponed to a further date or canceled must be notified as a value transfer to a healthcare professional; and all other types of payments within this category must be notified as a value transfer to a health institution.
- The donations made to provincial health directorates must be notified as a value transfer made to a provincial health directorate; and the donations made to a third-party health organization (e.g., public, private or university hospitals, laboratories, pharmacies, etc.), as directed by the directorate, must be notified as a value transfer made to a health institution.
- The donations made to a health institution through the associations/unions of which the license/authorization owner is a member must be notified as a value transfer made to an association/union. The relevant association/union must submit a list of institutions that accepted the donation until 31 December 2020 to the TİTCK by using the templates provided within the annexes of the TİTCK’s announcement. The deadline for the submission is 31 December 2021.
Conclusion
The TİTCK continues to provide guidance for license/authorization owners concerning significant procedures. License/authorization owners should carefully review the TITCK’s announcements and take the necessary actions to ensure compliance with the value transfer obligations.
