Recent Developments in Healthcare Legislation - Winter Issue 2025

Medicinal Products for Human Use

Amendment to the Regulation on the Licensing of Medicinal Products for Human Use. An amendment to the Regulation on the Licensing of Medicinal Products for Human Use has been introduced on 3 December 2024. Accordingly, depending on the source of the active substance, submission of certain documents and information as part of new marketing authorisation applications and ongoing authorisation processes has been made mandatory.

• For active substances sourced locally, the supply agreement executed between the marketing authorisation applicant and the supplier as well as the relevant invoices are required to be submitted as part of the applications and ongoing processes. As for the active substances sourced abroad, an approval letter issued in accordance with the Guideline on Import Applications and Market Release Authorization must be submitted.
• In co-marketing applications, a customs exemption letter or a feedback form document that has been approved with an import feedback tracking number for the active substance of the main product must be submitted.

Amendment to the Decision on the Pricing of Medicinal Products for Human Use. On 21 March 2025, an amendment was made to the Decision on the Pricing of Medicinal Products for Human Use. Accordingly, scales of wholesaler selling prices of pharmacist profit margins, which form the basis for the retail prices of medicinal products will be increased by the rate of change in Euro value. The medicinal products to be purchased through alternative reimbursement models mentioned in paragraph 8 of Article 2 of the relevant decision have been excluded from this arrangement.

Guideline for Static IP Registration and Update for the Drug Tracking System (ITS). ITS Static IP Registration and Update Guideline has been published to facilitate pharmacies’ compliance with the fixed Intellectual Property (IP) restriction for access to the ITS portal and internet services. The afore-mentioned guideline serves as a reference for the registration and update processes of fixed IP addresses, ensuring secure and uninterrupted access to the ITS system for pharmacies. The fixed IP restriction has come into force on 2 January 2025, and compliance with the same has become mandatory for all pharmacies as of 31 January 2025.

The mandatory fixed IP restriction aims to ensure that data controllers implement technical and administrative measures for the protection of personal data in accordance with Law No. 6698 on the Protection of Personal Data. As per the decision numbered 2018/10 of the Personal Data Protection Board, additional security measures are required for remote access to sensitive personal data. Accordingly, a new requirement, which allows pharmacies to access ITS portal and internet services only through predefined fixed IP addresses has been introduced. To ensure compliance with legal obligations and system security, pharmacies must complete the necessary steps outlined under the guideline.

Amendment to the User Guideline of the Turkish Medicines and Medical Devices Agency on Electronic Application System Relating to Provincial Health Procedures, Pharmacy Procedures and Pharmacovigilance Procedures. Detailed information has been provided in the new version of the guideline published on 1 December 2024 regarding the screens to be used for recording and searching provincial health accrual records.

Medical Devices

Amendment to the Guideline on the Implementation of the Regulation Regarding Sale, Advertising and Promotion of Medical Devices. With the amendment to the guideline dated 31 December 2024, certain changes have been introduced on the provisions concerning the issuance of warranty certificates, the obligations of technical service personnel, and qualification certificate of individuals who shall be authorised to make registrations under the Product Tracking System (ÜTS).

• As of 1 January 2025, individuals who do not hold a medical device registration officer qualification certificate will not be allowed to register medical devices under the ÜTS system. However, it will not be required to have received training from an authorised institution in order to perform notification procedures for medical devices that are already registered in the ÜTS.
• Additionally, individuals working at a sales centre under a work certificate, who have completed the necessary training to become a responsible manager, clinical support staff, sales and promotion staff, or medical device registration staff and who have passed the examination will be able to perform medical device registration processes in the ÜTS only for the sales centre where they are employed.
• Candidates identified to have acted in violation of the regulation concerning registration and information management system regulations under the Regulation Regarding Sale, Advertising, and Promotion of Medical Devices will not be able to register medical devices in ÜTS until they successfully complete the medical device registration officer training and obtain a qualification certificate.
• If an import permit is granted in the ÜTS by a sales centre for a medical device, which has already been registered in the system by another sales centre, both the registering and the importing sales centres will be jointly liable for the warranty certificate and technical service obligations of the imported device throughout its service life. According to the relevant amendment, joint liability shall not apply in cases where an import permit is not granted through the ÜTS.
• There is no obligation to issue a warranty certificate for a device that has already been placed on the market under the Regulation Regarding Sale, Advertising, and Promotion of Medical Devices. Similarly, there is no requirement to issue a warranty certificate for medical device accessories that are not sold together with a medical device.

Application Modules Prepared Within the Scope of Medical Device Clinical Researches and In-Vitro Performance Studies. It has been stated in the announcement published on the official website of the Turkish Medicines and Medical Devices Agency (“Agency”) dated 31 December 2024 that the application module for medical device clinical researches and the application module for in-vitro performance studies prepared within the Electronic Application System (EBS) have been activated in the system as of 1 January 2025. With this change, it will now be possible to file applications for first-time clinical researches/studies of medical devices sponsored by a commercial entity through the relevant module. Additionally, unless the Agency specifically requests the original documents, the requirement to submit the originals through physical application is no longer applicable. As for applications for modification or notification related to applications permitted prior to the system becoming operative on 1 January 2025, these will continue to be submitted through the general document application option previously used in the EBS.

Healthcare Services

Amendment to the Regulation on Private Health Institutions Providing Outpatient Diagnosis and Treatment. The Regulation Amending the Regulation on Private Health Institutions Providing Outpatient Diagnosis and Treatment has been published in the Official Gazette, and entered into force on 7 January 2025.

In this context:

• Prior to the amendment, physicians in certain specialties and those holding a medical aesthetics certificate were permitted to provide aesthetic healthcare services, provided that the required physical conditions were met. Upon the amendment, only physicians whose educational curriculum is appropriate and who have been qualified through certification will be allowed to provide aesthetic services within the scope of medical uses for which the healthcare institution where they work is authorized.
• The respective periods for suspension of license, preliminary permits and licensing procedures for private healthcare institutions have been extended until 30 June 2025.
• Medical centres that obtained licenses through on-site transformation will be allowed to fill their physician staffing vacancies in at least two specialties by 30 June 2025, even if the previously granted three-year period has expired.
• Polyclinics that were licensed other than Type A or Type B license before 16 January 2024 must convert their licenses to Type A or Type B by 30 June 2025. Otherwise, their licenses will be revoked.

Communiqué on Amendment to the Communiqué Regarding Implementation Principles and Procedures for the Intensive Care Services in Inpatient Healthcare Centres. Upon publication in the Official Gazette dated 7 January 2025 of the said Communiqué, the deadlines for compliance with the regulations stipulated under the provisional article of the Communiqué Regarding the Implementation Principles and Procedures for the Intensive Care Services in Inpatient Healthcare Centres have been amended. Accordingly:

• The exemption period for compliance with the minimum physical area standards set forth under the communiqué has been extended until 30 June 2025 for registered or temporarily registered intensive care services operating before 20 July 2011, as well as those within healthcare facilities that obtained prior hospital approval from the Ministry of Health, provided that their physical infrastructure inadequacy is documented through a commission report.
• The deadline for compliance with the mandatory standards set forth under the communiqué regarding the number of beds and the minimum required number of cardiovascular surgery specialists in cardiovascular surgery intensive care units within the operative private healthcare centres has been extended until 30 June 2025.
• Personnel working in newly established or existing intensive care services who do not meet the requirement of having completing intensive care training will, upon obtaining an official report in this regard, be exempt from the obligation to attend intensive care training until 30 June 2025.
• The deadline for satisfaction of the requirements set forth under the Communiqué for the intensive care services in hospitals that obtained their license before 21 August 2020, or that are in the process of obtaining their license or pre-license, has been extended until 30 June 2025.

Amendment to the Regulation on Private Hospitals. Upon publication in the Official Gazette dated 30 January 2025 and entering into force of the Regulation on Private Hospitals, the former regulation, which was published in the Official Gazette on 27 March 2002 has been repealed. Unlike the former regulation, the new regulation introduces detailed provisions regarding the supervision and operation of private hospitals and protection of patient rights, and signals a new era. For more detailed information on the amendment, please refer to our announcement published on 6 February 2025 https://paksoy.av.tr/2025/02/ozel-hastaneler-mevzuatinda-gelismeler/

Abolition of the Communiqué on the Notification of Contagious Diseases and Notice System. Upon publication in the Official Gazette dated 8 March 2025 and entering into force of the Communiqué Regarding the Abolition of the Communiqué on the Notification of Contagious Diseases and Notice System, the Communiqué on the Notification of Contagious Diseases and Notice System published in the Official Gazette dated 6 November 2004 has been repealed. Following the said communiqué having been repealed, it is expected that a new piece of legislation on the matter shall be put in place.

Amendment to the Social Security Institution Communiqué on Healthcare Practices and the Decision of the Healthcare Services Pricing Commission. Within the scope of the Communiqué published and entered into force on 8 March 2025 Amending the Social Security Institution Communiqué on Healthcare Practices and the Decision of the Healthcare Services Pricing Commission, among others, detailed provisions have been introduced regarding healthcare services provided by non-contracted healthcare providers in emergency cases. It has been regulated under the amendment that healthcare expenses incurred in cases of emergency will only be covered upon submission of a document signed by the doctor involved in the specific matter and approved by the Social Security Institution. Additionally, information related to emergency treatments must be recorded by non-contracted healthcare providers and presented to the Social Security Institution when required.