Recent Regulatory Changes in Life Sciences & Healthcare Sector in Turkey
During August and September 2024, the Turkish authorities have introduced a number of changes to the existing regulations and adopted/updated several guidelines that concern the areas of medical devices, pharmaceutical products, and active pharmaceutical ingredients. We summarise the key changes below.
Regulation Amendments
Amendment to Medical Device Regulation
On 17 August 2024, several new provisions amending the Medical Device Regulation were enacted by the Turkish Medicines and Medical Devices Agency (“TMMDA”). Under these new provisions, from 10 January 2025 medical device manufacturers will be subject to the below obligations in cases where the supply of medical devices is to be interrupted or discontinued:
- if a manufacturer foresees an interruption or discontinuation in the supply of a device (other than a custom-made device) and reasonably anticipates that such an interruption or discontinuation may result in serious harm or a risk of serious harm to patients or public health in Turkey or one or more EU Member State, the manufacturer is obliged to inform the TMMDA, as well as the economic operators (e.g., manufacturers, authorised representative, importers or distributors), healthcare institutions, and healthcare professionals to whom the device is directly supplied.
- other than in exceptional circumstances, this notification must be made six months before the anticipated interruption or discontinuation.
- following this notification, the economic operators are required to promptly inform other economic operators, healthcare institutions, and healthcare professionals to whom they directly supply the device.
- after receiving such notification from the manufacturer, the TMMDA will promptly inform the competent authorities of the relevant EU Member States and the Commission about the anticipated interruption or discontinuation.
The text of the amendment can be accessed here (in Turkish only).
Amendment to In Vitro Diagnostic Medical Device Regulation
On 17 August 2024, the TMMDA also enacted a number of amendments to the In Vitro Medical Device Regulation. In parallel to the above changes to the Medical Device Regulation, several of the amendments to the In Vitro Medical Device Regulation extend the above obligations to the manufacturers of in vitro medical devices.
In addition, the amendments on 17 August 2024 introduce certain changes to the deadlines for the market availability of certain types of in vitro medical devices that were certified under the repealed Regulation on In Vitro Diagnostic Medical Devices:
- devices with a valid certificate issued pursuant to the repealed Regulation on Medical Diagnostic Devices for In Vitro can be placed on the market or put into service until 31 December 2027 (previously 26 May 2025 before the amendment);
- devices that, under the repealed Regulation on In Vitro Diagnostic Medical Devices, did not require the involvement of a notified body for the conformity assessment procedure and for which a declaration of conformity was issued before 26 May 2022 but now require the involvement of a notified body for conformity assessment under this Regulation, may be placed on the market or put into service until the following deadlines:
- Class D devices: 31 December 2027 (previously 26 May 2025 before the amendment);
- Class C devices: 31 December 2028 (previously 26 May 2026 before the amendment);
- Class B devices and Class A devices placed on the market in a sterile condition: 31 December 2029 (previously 26 May 2027 before the amendment);
provided that:
- the above devices continue to comply with the repealed Regulation on In Vitro Diagnostic Medical Devices;
- there are no significant changes in design or intended use;
- the devices do not pose an unacceptable risk to the health or safety of patients, users, or other individuals, or to public health;
- the manufacturer implements a quality management system by 26 May 2025;
- the manufacturer or authorised representative submits a formal application to a notified body for a conformity assessment related to the device or a device intended to replace it, in accordance with the requirements of Annex VII, section 4.3 of the In Vitro Medical Device Regulation by the specified deadlines; and
- the manufacturer and the notified body sign a written agreement under Annex VII, section 4.3 of the In Vitro Medical Device by the specified deadlines.
The text of the amendment can be accessed here (in Turkish only).
New Regulation on Cannabis for Producing Active Pharmaceutical Ingredients
On 13 September 2024, the Ministry of Agriculture and Forestry issued a regulation regarding the cultivation of cannabis for the purpose of producing active pharmaceutical ingredients. According to this new regulation:
- individuals or legal entities wishing to cultivate cannabis for the production of active pharmaceutical ingredients must obtain a competency certificate and a cultivation permit;
- applications are evaluated based on the quota determined by the President of Turkish Republic according to the country's supply and demand situation;
- individuals or legal entities whose applications are approved must obtain a manufacturing site permit from the TMMDA within 18 months from the notification date;
- the domestic sale of active pharmaceutical ingredients must be made to individuals or legal entities authorised by the Ministry of Health.
The text of the new regulation can be accessed here (in Turkish only).
New Guidelines
Guideline on the Implementation of the Regulation on Technical Services for Medical Devices Used in Medical Services
On 21 August 2024, the TMMDA published the Guideline on the Implementation of the Regulation on Technical Services for Medical Devices Used in Medical Services. From 1 January 2026, only technical services authorised under the said regulation will be able to perform technical service activities for Group A, B, and C medical devices.
Key points under this guideline include:
- entities seeking a technical service activity certificate must apply electronically via the product tracking system (ürün takip sistemi), provided that they meet the conditions outlined in the regulation and the guideline;
- once the application is duly made, the applicant will be notified of an on-site inspection date, if required by TMMDA, and must pay the inspection fee at least three business days before the inspection;
- if there is any missing element in the application, the applicant will have 45 business days to complete them through the product tracking system—failure to do so will result in the cancellation of the application, with no refund of fees paid;
- private or foreign service providers may not perform technical activities without a signed/certified document from the manufacturer or importer confirming authorisation for modifications, updates, and upgrades.
- Inspections initiated by the TMMDA, whether based on complaints or ex officio, will begin with an official notice to the technical service provider. If necessary, TMMDA may conduct unannounced inspections.
The text of the guideline can be accessed here (in Turkish only).
Updated Guideline on the Supply of Pharmaceutical Products from Abroad
The Guideline on the Supply of Pharmaceutical Products from Abroad is part of the regulatory instruments that implement the designated patient programs in Turkey for importing pharmaceutical products without marketing authorisation. The Guideline was republished with some changes on 2 September 2024. The major changes are as follows:
- it has been made clear that the active ingredients that are deemed appropriate by the Foreign Medicine Evaluation Board for the initial application process are published by the TMMDA;
- in respect of such initial applications containing active ingredients listed in the Foreign Active Ingredient List, the applicant is required to submit both clinical and non-clinical information and study reports along with periodical benefit/risk assessment reports. If these cannot be provided, a justification and alternative documents must be submitted. This rule applies to both products licensed by authorities other than the European Medicines Agency (“EMA”) and to products licensed by the EMA and subject to additional monitoring by the EMA.
The text of the guideline can be accessed here (in Turkish only).
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