articles

Guidelines on Medical Device Meetings Has Been Updated

Published 06 February 2024 by Dicle Doğan. Gün + Partners, Turkey

On 4 January 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) announced on its official website that the Guidelines on Scientific Meetings and Educational Events to be Held within the Scope of the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Guidelines”) has been updated.

Within the scope of the update, only in the third paragraph of Article 9 of the Guidelines, which came into force on 04 January 2024, the following issues have been regulated in addition to the amendment detailing the application process:

  • The most important change introduced by the amendment to the Guideline is that the Agency will charge a fee for scientific meetings and educational activities applications and that payments made to the Agency for applications regarding scientific meetings or educational activities that are later cancelled will not be refunded. Accordingly, in the 2024 Price Tariff of the Agency, the application fee for scientific meetings and educational activities notifications has been determined as TRY 1,114.02 (approximately EUR 34). It is observed that the amendment does not make any distinction between web-based meetings and physical meetings in terms of application fee payment.
  • The format in Annex 2 of the Guidelines provided for the document to be uploaded to the “Commitment Letter of the agency undertaking the organization” section has been removed and therefore, the obligation to upload the agency commitment letter to the Electronic Application System within the scope of the notifications to be made has been removed.

The Guidelines published by the Agency following the amendment dated 17 August 2023 to the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Regulation”) were introduced in relation to the organization and support of scientific meetings and educational activities. It is expected that the Agency will continue to make such amendments to the Guidelines from time to time in order to fulfil the needs and to overcome the difficulties arising in the implementation of the new rules. However, considering that the main motivation of the Agency in the amendments to the Regulation and the Guidelines is to facilitate notifications for scientific meetings and educational activities, to increase the number of notifications and to ensure transparency in the activities of the industry, the introduction charge a fee for scientific meeting and educational activity notifications are criticized as it may have the opposite effect by imposing a financial obligation on firms.

In addition, according to the 2024 Price Tariff of the Agency, it is understood that pharmaceutical companies subject to similar application procedures will also be charged fees for “Pharmaceutical Product for Human Use Scientific Meeting Sponsorship Application” and “Pharmaceutical Product for Human Use Promotional Meeting Application”. However, no amendment has yet been made to the guidelines on the activities of pharmaceutical products for human use.