The Turkish Medicine and Medical Devices Agency ("Agency") of the Ministry of Health issued an announcement on April 27, 2020 updating the Guidelines for Scientific Meetings and Educational Activities based on the Regulation on the Sale, Advertising and Promotion of Medical Devices ("Guidelines").1 In brief, the Guidelines have been updated to include provisions regarding online meeting and seminars as well.
With the announcement of the new Guidelines, the previous guidelines for scientific meetings and educational activities have been repealed.
Accordingly, several provisions along with the current regulations in the Guidelines can be summarized as follows:
- The Guidelines introduces a new term called "web based meeting" which is defined as online seminars, video conferences or meetings that can be observed through the network.
Medical device sales centers must notify the Agency regarding any scientific and educational meetings to be organized or sponsored before and after the meetings.
- Medical device sales centers must complete their pre-meeting notification applications electronically through the Agency's Electronic Application System within at least (15) days before the meeting.
- Relevant applications to the Agency must contain information on meeting schedule, website address that the meeting announcement is made, meeting place, the association organizing the meeting, a list of the potential participants, cost items and any other information relating to the meeting.
- Agency will reply the electronic applications within ten (10) business days from the receipt date of application. If the Agency does not reply to an electronic application, approval for the application is deemed given. If there is a deficiency in the application, the Agency must notify about deficiencies to the applicants to be completed electronically within five (5) business days. All changes regarding the participants are reported to the Agency until the beginning date of the meeting.
- Medical device sales centers are not obliged to notify the Agency for web-based meetings if they did not supply any technical equipment (devices, equipment, software, etc.) and/or make any value transfers.
- Medical device centers must also make post-meeting notifications to the Agency one (1) month after the scientific meeting or educational activity is held or carried out at the latest.
- Post meeting notifications to the Agency must include a list of participants, cost items and any other information on the events (including information provided to the Agency during the pre-meeting notification). These notifications on web-based meetings will be made in accordance with the rules applicable to educational activities.
1. The Guidelines can be accessed at https://titck.gov.tr/storage/Archive/2020/announcement/Klavuzmetni_f1bc4536-4bdb-4f0c-ba98-de62c4bbddce.pdf (Last accessed on May 25, 2020).
This article was first published in Legal Insights Quarterly by ELIG Gürkaynak Attorneys-at-Law in June 2020. A link to the full Legal Insight Quarterly may be found here
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