The Agency first announced on its official website on 4 January 2024, that the Guidelines on Scientific Meetings and Educational Activities to be Conducted within the Scope of the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Guidelines”) was amended, and that the most significant change introduced by the amendment to the Guideline is the collection of fees by the Agency for scientific meetings and applications for educational activities. According to this amendment, it will not be possible to refund the payments made to the Agency for scientific meetings or educational activities applications that are subsequently canceled. In this context, the application fee for scientific meetings and educational activities notifications applications to be made has been set as TRY 1,114.02 (approximately EUR 34) in the 2024 Price Tariff of the Agency. Within the scope of the amendment, no distinction is made between web-based meetings and physical meetings in terms of the payment of the application fee.
Subsequently, the Agency made an addition to the 2024 Fee Tariff and then announced on its website on 18.01.2024 that a service fee would be charged for "Human Medicinal Product Scientific Meeting Support Application", "Human Medicinal Product Promotion Meeting Application" and "Human Medicinal Product Press Announcement Application".
The fact that the application fee regulation is made through guidelines and announcements raises questions about the soundness of the legal basis of the relevant regulation in terms of administrative law. Also, considering that the main motivation of the Agency making 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 amendment to introduce an application fee may have the opposite effect by imposing a financial burden on companies or may lead to a decrease in number of the promotional activities.
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