Recent Development
On April 14, 2020, the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) updated the Guidelines for Scientific Meetings and Educational Activities According to the Regulation on the Sale, Advertising and Promotion of Medical Devices (“Guidelines“). The TİTCK included provisions on web-based meetings in the Guidelines. The Guidelines are available online here (in Turkish).
What’s New?
The Guidelines regulate the principles and procedures regarding medical device sales centers’ scientific and educational activities according to the Regulation on the Sale, Advertising and Promotion of Medical Devices. Accordingly, medical device sales centers must notify the TİTCK of any scientific and educational meetings they wish to organize or sponsor before and after the meeting.
Medical device sales centers must complete their pre-meeting notifications electronically through the TİTCK’s Electronic Application System 15 days before the meeting. Notifications to the TİTCK must include the content of the meeting, a list of the potential participants, cost items and any other information relating to the meeting. Medical device sales centers are not required to notify the TİTCK for web-based meetings if they did not provide any technical equipment (devices, equipment, software, etc.) and/or make any value transfers.
Medical device centers must also make post-meeting notifications to the TİTCK one month after the scientific meeting or educational activity is held/carried out at the latest. Notifications to the TİTCK must include a list of participants, cost items and any other information on the events (including information provided to the TİTCK during the pre-meeting notification). Post-meeting notifications regarding web-based meetings will be made in accordance with the rules applicable to educational activities.
Conclusion
The TİTCK continues to guide medical devices companies regarding their obligations under the healthcare regulations. Accordingly, companies should carefully review the TİTCK’s guidelines and make their pre-meeting and post-meeting notifications to the TİTCK regarding scientific or educational meetings they wish to organize or sponsor in line with the TİTCK’s instructions.
Please refer to The Esin Attorney Partnership Coronavirus Helpdesk for our client alerts regarding the legal consequences of COVID-19 on other areas.
