Healthcare & Life Sciences Newsletter - October 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published i) the Announcement on Applications for Product Tracking System (ÜTS) of Medical Devices That Will Not Be Certified By The Manufacturer In Accordance With The New Medical Device Regulation (MDR), and ii) the Announcement on Suspension of Health Declaration.

The TİTCK also amended i) the Guideline on Biosimilar Pharmaceuticals, ii) the Guideline on Chemical and Pharmaceutical Qualifications for Pharmaceuticals Used in Clinical Trial, iii) the Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices.

Guideline on Biosimilar Pharmaceuticals

On 2 September 2024, the TİTCK updated the Guideline on Biosimilar Pharmaceuticals. In this regard, marketing authorization with a complete file may be more appropriate where there are significant quality differences between the biosimilar and the reference pharmaceuticals and where proving similarity to the reference pharmaceuticals is difficult due to in the lack of a clinically relevant effect. In addition, the applicant of marketing authorization shall make appropriate changes to the manufacturing process to minimize or eliminate discrepancies.

The Guideline is available here (in Turkish).

Guideline on Chemical and Pharmaceutical Qualifications for Pharmaceuticals in Clinical Trial

On 16 September 2024, the TİTCK updated the Guideline on Chemical and Pharmaceutical Qualifications for Pharmaceuticals in Clinical Trial. The effective date of the requirement to submit an research product file in bioequivalence study applications has been postponed to 1 January 2025.

The Guideline is available here (in Turkish). 

Announcement on Applications for Product Tracking System (ÜTS) of Medical Devices That Will Not Be Certified By The Manufacturer In Accordance With The New Medical Device Regulation (MDR)

On 23 September 2024, the TİTCK published the Announcement on Applications for the Product Tracking System (ÜTS) of Medical Devices That Will Not Be Certified by the Manufacturer in Accordance With the New Medical Device Regulation (MDR). In this regard, individually notified products with a shelf life that are i) currently in the manufacturer’s warehouse, and ii) imported from non-EU countries and currently in the importer’s warehouse, can remain on the market for their shelf life. Products without a shelf life shall not be subject to the notice of departure as of 31 December 2025.

The Announcement is available here (in Turkish).

Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices

On 27 September 2024, the TİTCK updated the Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices. The main amendments introduced by the Guideline are as follows: ­

– Medical device sales centers shall provide technical services for medical devices and their accessories for which they are the manufacturer or importer within the scope of the Regulation on Technical Services for Medical Devices Used for the Provision of Medical Services.

– Sales centers that have not r egistered their commitment to provide technical services for Group A, B and C medical devices (as listed in the annex of the Guideline on the Implementation of the Provisions of the Regulation on Technical Services for Medical Devices Used for Provision of Medical Services) and their accessories for the devices’s lifetime in accordance with the relevant legislation to the Product Tracking System (“ÜTS”) shall not be able to register these devices to the ÜTS as of 1 January 2025.

– Unless the sales centers that manufacture or import Group A, B and C devices and their accessories commit to providing technical services throughout the device’s lifetime in accordance with the legislation and register this commitment in the ÜTS before 1 January 2025, the registrations of these devices will be de-registered after 31 March 2025.

– After 1 January 2025, sales centers acting as manufacturers or importer of Group A, B and C devices and their accessories must register their commitment to provide technical services for these devices for their lifetime, in accordance with the legislation, in the ÜTS within 3 months of the device’s inclusion in the relevant Guideline. Otherwise, the ÜTS registration of these devices will be deregistered.

– Sales centers must fulfill the spare part requests from the technical services authorized by the TİTCK or the healthcare service provider that will use the device they manufacture or import, within 20 business days for domestic supply and 30 business days for international supply. When calculating the time elapsed for the supply of spare parts, the period between the request date and the delivery date to the requested location shall be considered (excluding the time for approval at the request location).

– The period for overseas procurement will be maximum of 90 business days in cases of delays beyond the sales center’s control. In the case of force majeure, this period may be extended as deemed appropriate by the TİTCK based on the submitted information and documents.

– Sales centers must provide necessary passwords and similar information required for technical service activities for devices they manufacture or import for the device’s lifetime, free of charge within 24 hours of a request from the healthcare service provider using the device.

– If the healthcare service providers choose to replace a device u nder the warranty certificate with an unused equivalent, the 45-day period for fulfilling the request may be extended up to 180 days if this causes disproportionate difficulties for the sales center , as deemed appropriate by the TİTCK.

– No further certificate will be required for the accessories of the device covered by the warranty certificate.

– The warranty certificate which is accepted by the healthcare service provider through a tangible media, may be provided via text message, e-mail, internet, disk, CD, DVD, memory card and any other similar means or media that enables the healthcare service provider to save the information sent to it in a way that ensures the healthcare service provider to examine the information sent to it for a reasonable period of time in accordance with the purpose of this information and to copy it unchanged and to access this information exactly as it is.

– The warranty period shall start from the invoice date after the acceptance of the device by the healthcare provider. In cases where the invoice must be issued before the acceptance of the device due to the commercial agreement or different financing models, this period shall start as of the date of acceptance of the device regardless of the invoice date.

– The warranty certificate shall include the lifetime period determined by the manufacturer when the device is placed on the market.

The Guideline is available here (in Turkish).

Announcement on Suspension of Health Declaration

On 30 September 2024, the TİTCK published the Announcement on Suspension of Health Declaration. The statements contained in health declarations regarding probiotic microorganisms and prebiotic ingredients stipulated in the Regulation on the Use of Health Declarations in Food and Food Supplements and the Guideline on the Use of Health Declarations in Foods and Food Supplements has been re-evaluated by the TİTCK.

The main amendments introduced by the Announcement are as follows: ­

The health declaration for food and food supplements shall include at least 1.0x108 CFU/g (kob/g) of at least one type of microorganism in the daily intake amount.

The prebiotic ingredient health declaration shall be suspended on the basis that there is insufficient scientific evidence to support it and there is no official dietary recommendation on “adequate intake” or “recommended daily amount” for prebiotics in healthy individuals. ­

Products that are currently released to the market or have been manufactured but not released to the market and use health declarations, and products that have been approved to be manufactured and of which labels contain health declarations, shall only be able to contain the relevant health declarations on their labels in their existing form until the date of finalization of the decision, and products outside of these situations shall not be able to contain the relevant health declarations.

The Guideline is available here (in Turkish). 

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.