Recent Amendments to the Regulation on Sales, Advertisement and Promotion of Medical Devices
Turkish Medicines and Medical Devices Agency (“TMMDA”) has recently introduced amendments to the ‘Regulation on Sales, Advertisement and Promotion of Medical Devices’ (“the Regulation”), which is published in Official Gazette on September 02, 2020 and entered into force on the very same date.
The most significant amendment is made to the scope of the advertisement of medical devices. Before the respective amendment, the advertisement of medical devices was freely made to public except for the devices that are intended to be used or applied exclusively by healthcare professionals and the devicesthat are subject to reimbursement. As a result of the amendment, the following advertisement of the following medical devicesto public is strictly prohibited (i) Medical devices that are sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthosis centers or optician institutions or dental prosthesis laboratories, (ii) Devices that are intended to be used or applied exclusively by healthcare professionals or that require application in medical device sales centers. The advertisement of other devices, except for the devices listed under Annex-3, can only be made via the internet environment where the device is sold. The devices under Annex-3, which can be advertised without any limitation of environment are toothpaste, dental prosthetic care products, condom, underpads, incontinence pad, hot cold compress applied topically, band-aid, plaster, cotton, mouthwash and breathtaking nose strips.
Other amendments to the Regulation are briefly explained hereinbelow;
The scope of the Regulation was redefined to be covering ‘the placing on the market, maintaining the availability on the market, advertising, information, clinical support, promotion and marketing activities, registration in the registration and information management systems determined by TMMDA concerning the Medical Devices’
Moreover, Dental Prosthesis Laboratories within the Dental Prosthesis Laboratories Regulation has been excluded from the scope, although the trade, advertisement, information, clinical support and promotion activities, registration procedures and information management systems concerning the medical devices placed on the market through these locations, are determined to remain within the scope.
The reference legislation has also been updated as the ‘Presidential Decree on Organization o Affiliated, Related, Associated Institutions and Organizations with Ministries and Other Institutions and Organizations’ (Presidential Decree numbered 4).
The definitions of the terms ‘direct sale’, ‘placing on the market’, ‘maintaining the availability on the market’, ‘individual notification’, ‘consumer’ and ‘inducement’ have been provided within the Regulation.
Within the former regulation, a person requesting to obtain authorization for a sales center was requested to submit business license obtained from the relevant authority along with certain other documents. With the amendments, the requirements have been further detailed and it is required to submit ‘business license obtained from the relevant authority, in the event that the site to be authorized is in a free zone, teknokent or organized industrial zone, the document obtained from the administration of the relevant place, indicating that the applicant real or legal person is operating in the relevant teknokent or organized industrial zone, or in the event that the applicant is a pharmaceutical wholesaler of the real or legal person, the pharmaceutical warehouse license issued by the Authority’.
The period for the sales center to notify the Provincial Directorate of Health of the events that responsible manager to resign, take part with the center or losing the necessities to function as the responsible manager; was increased to be 10 business days and of the events that responsible manager to pass was increased to be 20 business days. In case of a failure to assign a new responsible manager in 30 business days, the activities of the sales center is temporarily suspended.
The very same obligation to notification is also brought for the sales and promotion staff; but the activities of the sales center is temporarily suspended, in case of failure to assign a new responsible manager in 60 business days.
If advertisements made contrary to the provisions of this Regulation are detected, the medical device sales center will be warned to eliminate such non-compliance. If the specified noncompliance is not eliminated within 3 business days as of date of notification, the sales activity of the medical device sales center would be suspended for 15 days. Advertisements to the public may also be notified to Ministry of Commerce and relevant organizations.
Within the former regulation, it was regulated the sales centers cannot operate in the same buildings and outbuilding with the health institutions, and in the improved lands as health institutions belonging to health organizations. With the amendments, the restrictions have been revised to exclude ‘the buildings in which there are clinics and policlinic established by physicians and dentists and laboratory diagnostic centers serving for diagnosis and visualisation purposes, pharmacies, opticians, hearing aid centers, custom-made prosthesis and orthosis centers, dental prosthesis laboratories.’
The structure of some provision have also been revised; yet hereinabove explanations are concerning the main essential changes. The implementation of such provisions are yet to be seen in the future.
Published on lexology.com on 28 December 2020