Recent Developments in Healthcare Legislation - Q2 2025

Contents

Medicinal Products for Human Use

Amendment to the Regulation on the Clinical Trials of Medicinal Products for Human Use. On 5 June 2025, the Regulation on Clinical Trials of Medicinal Products for Human Use underwent certain amendments.

Prior to the assignment of the research team, information regarding the principal investigators shall be submitted to both the ethics committee and the Turkish Medicines and Medical Devices Agency (“Agency”), information regarding the auxiliary clinical research staff will be submitted to the ethics committee first and to the Agency if and when requested by the Agency.
The institutions where clinical trials can be conducted have been comprehensively redefined, the phrase “affiliated to the Ministry or universities” has been removed from the regulation, and it has been stipulated that clinical trials can only be conducted in healthcare institutions and R&D centres that meet the standards determined by the Agency.
The qualifications required to serve as principal investigator in compliance with Good Clinical Practices have been clarified; it has been regulated that basic science doctorate holders as well as those specialised in internal and surgical medical sciences can also serve as researchers.

With these amendments, the updated regulation entered into force on the date of its publication, and the President of the Agency has been authorised for matters related to its implementation.

Amendment to the Guidelines on the Import Applications and Marketing Authorisation. Under the updated version of the relevant guideline published on 27 March 2025, it is now obligatory to submit the Good Manufacturing Practices (GMP) Certificate issued by the Agency for the place of production of the product in the applications to be made for ”Approval of the Control Certificate and Market Release Authorization for Medicinal Products for Human Use Containing Blood Products or Blood Products” and “Approval of the Control Certificate and Market Release Authorization for Import of Immunological Medicinal Products for Human Use”.

Amendment to the Guideline on the Safety Notifications in Clinical Trials. The updated version of the relevant guideline, published on 15 April 2025, introduces detailed provisions regarding the reporting to the Agency of serious adverse events resulting in death. In this context:

It is expressly stated that serious adverse events occurring during the clinical trial should be reported to the Agency not only by the investigator but also under the knowledge and responsibility of the sponsor. With this provision, the obligation to report serious adverse events is imposed not only on the researcher but also on the sponsor. The investigator must initially notify the sponsor of serious adverse events within the first 24 hours. The sponsor is required to report the same to the Agency within 7 days.
The mandatory notification period to the Agency and the relevant ethics committee regarding any changes that increase the risk to the volunteer as well as any significant new information that may adversely affect the safety of the volunteer, or the conduct of the research has been reduced from 15 days to 7 days.
A new type of application document has been introduced, and “Sample Cover Letter for Notification on Serious Adverse Event Resulting in Death” has been published. Furthermore, it is envisaged that notifications to the Agency will be submitted through the electronic application system.
In addition to the adverse event or reaction notifications, the sponsor is required to notify the relevant ethics committee and Agency, once a year or upon request, of recent safety updates that has occurred within the reporting period, together with a cover letter published on the official website of the Agency.

Association of Research-Based Pharmaceutical Companies (AIFD) and European Federation of Pharmaceutical Industries and Associations (EFPIA) Türkiye Pharmaceutical Sector 2024 Report. According to this report, in addition to incentive programmes, quality of the legal and regulatory infrastructure plays a decisive role in the increase in international direct investments in the Turkish pharmaceutical sector. In the decision-making processes of foreign investors, factors such as protection of intellectual property rights, existence of a predictable and stable legal framework, effective implementation of regulations, existence of sustainable pricing and reimbursement mechanisms, and transparency of clinical research processes are taken into account. Türkiye continues to be an attractive market for investors in the pharmaceuticals sector with its policies encouraging domestic production, collaborations involving global technology transfers and increasing R&D investments. However, strengthening the intellectual property protection system and ensuring uniformity in implementations are among the important factors that can accelerate the flow of direct investments in the sector by increasing predictability for investors.

Medical Devices

Announcement on the Obligations of Economic Operators in Case of Interruption or Suspension of Supply of Medical Devices. With the announcement published on the official website of the Agency on 22 May 2025, within the scope of harmonisation with the European Union (“EU”) legislation, for medical device products for which supply interruption is expected or will not be supplied, companies supplying such products to the market are obliged to notify the competent authorities in accordance with the procedures and principles determined by the Agency. In this context, except for custom-made devices, in relation to all device models or types placed on the market, the supply interruption or suspension (or cessation) of which may reasonably be expected to result in serious harm or causse risk of serious harm to patients or public health in Türkiye or in more than one EU member state;

Manufacturers operating in Türkiye are required to notify the Agency via the Electronic Application System and the e-mail address determined by the Agency at least 6 months before the date on which the interruption or suspension foreseen by the manufacturer is expected to take place, except for exceptional circumstances. Within the scope of the relevant notification, information such as (i) the manufacturer, (ii) where applicable, the authorised representative and other organisation, (iii) the risk classes of the medical device and the description of the device in terms of various categories, and (iv) the justification for the interruption or suspension of supply should be provided as stipulated under the Manufacturer Information Form.
The notification obligation must be fulfilled by companies operating as the EU authorised representative appointed in our country on behalf of the manufacturer located outside the EU member states in accordance with the procedures and principles determined by the Agency.
Since the manufacturers located in the EU Member States will make such notifications to the competent authority in the country where they are located, there is no separate notification required to be made by the importer companies selling the products of these manufacturers in Türkiye. However, in case the supply interruption or suspension of the supply of the relevant product to the market will take place only within the borders of Türkiye, companies importing the relevant product must also fulfil the notification obligation in accordance with the procedures and principles determined by the Agency.

Announcement on the Product Tracking System (“ÜTS”) Registration Processes of Products Upgraded in the Scope of In-Vitro Diagnostic (“IVD”) Medical Device Regulation. Through the announcement published on the official website of the Agency on 22 May 2025, principles regarding the registration procedures in the Product Tracking System (ÜTS) for products to be placed on the market during the transition period under the In Vitro Diagnostic Medical Devices Regulation (“the Regulation”)—specifically those requiring the involvement of a notified body (Class A-sterile, Class B, Class C, and Class D)—have been set out. Accordingly, it is required that the risk classification of the product be declared by the company placing the product on the market. Within the scope of the relevant declaration, the product description section under the identifying information on the medical device registration screen in the PTS must be entered with the application-free update process, and the classification information stipulated under the Regulation must be specified. In this context:

For products currently classified under the IVD-Other risk class in the ÜTS; if the relevant explanation text is not added until 30 June 2025, the necessary actions on the records of the relevant products will be carried out by the Agency.
For products in the IVD-Other risk class that are submitted to the Agency for registration for the first time or with an update application, the relevant description text must be included in the product description section. Applications that do not include product description information will be refused by the Agency.
In addition, applications will need to be made by the below-mentioned deadlines in relation to declarations of conformity for products in the risk IVD-Other risk class within the scope of the Regulation, which continue to be registered in the ÜTS by adding the relevant explanation information:

- For devices to be placed on the market in the risk class of personal test device, bedside test device and supportive diagnostic device in accordance with Class D; by 26 May 2025;
- For devices to be placed on the market in the risk class of personal test device, bedside test device and supportive diagnostic device in accordance with Class C; by 26 May 2026; and
- For devices to be placed on the market in the risk class of bedside test device and class A sterile in accordance with Class B, by 26 May 2027.

Healthcare Services

Regulation on the Independent Practice of Healthcare Professionals. The Regulation on the Independent Practice of Healthcare Professionals entered into force upon publication in the Official Gazette dated 29 March 2025. The Regulation comprehensively sets out the procedures and principles regarding the independent practice of healthcare professionals such as clinical psychologists, dieticians, nurses, physiotherapists, and speech and language therapists.

Amendment to the Regulation on Private Healthcare Institutions Providing Outpatient Diagnosis and Treatment. The Regulation on Private Healthcare Institutions Providing Outpatient Diagnosis and Treatment was published in the Official Gazette dated 19 April 2025 repealing the Regulation on Private Healthcare Institutions Providing Outpatient Diagnosis and Treatment published in the Official Gazette dated 15 February 2008. Not all provisions of the regulation have entered into force on the date of publication, and some provisions are subject to transition periods. More detailed information regarding the amendments introduced by the regulation can be accessed from our announcement dated 29 April 2025: https://paksoy.av.tr/en/2025/04/regulation-on-private-health-institutions-providing-outpatient-diagnosis-and-treatment/

Amendment to the Regulation on the International Healthcare Tourism and Tourist Healthcare. The Regulation on the International Healthcare Tourism and Healthcare of Tourists was published in the Official Gazette dated 26 April 2025, and the Regulation on International Healthcare Tourism and Healthcare of Tourists published in the Official Gazette dated 13 July 2017 was repealed. In this context:

All healthcare facilities and intermediary organisations operating in the field of healthcare tourism are required by the Ministry of Health (“Ministry”) to work in integration with the HealthTürkiye portal for the purpose of registration, monitoring, supervision, and surveillance of international healthcare tourism activities. Under the regulation, it has been made mandatory to identify responsible personnel working in the international healthcare tourism unit for the international healthcare tourists applying to the healthcare facility and to register the relevant personnel information on the portal.
It has been made mandatory for the healthcare facilities to have complication insurance for surgical and interventional procedures to be performed in the operating theatre environment within the scope of international healthcare tourism. Complications and medical malpractices that may arise after provision of healthcare services will also be considered within the scope of this responsibility. Healthcare facilities are required to take out this insurance until 31 December 2025.
Hospitals, medical centres, medical laboratories, and dialysis centres must be accredited by TÜSKA. Other healthcare facilities are required to obtain the certificate issued by the Ministry of Health. In this context, healthcare facilities are required to obtain the relevant certificate until 31 December 2026.
Foreigners who stay in Türkiye for meetings, congresses, commercial or tourism purposes may benefit from healthcare services provided by public institutions and organisations, universities, or private healthcare institutions in case of sicknesses and emergencies that develop during this period. However, these tourists cannot receive follow-up healthcare services after sudden illnesses and emergencies from healthcare facilities that do not have an authorisation certificate.
Sanctions mentioned in Annex-4 and Annex-5 of the Regulation will be applicable in case of non-compliance with the procedures and principles in the regulation. In this context, administrative fines varying between TRY 50,000 and TRY 100,000 for the first detected violation shall be imposed. In case of continued violations, depending on the nature of the violation, more severe sanctions such as increasing administrative fines, suspension of activities until the violation is ceased and cancellation of the authorisation certificate are stipulated.

Amendment to the Regulation on the Procedures and Principles Regarding the Investigation of Healthcare Professionals Due to Medical Procedures and Practices and Recourse of Compensation Paid by the Administration. On 5 June 2025, amendments were made to the Regulation on the Procedures and Principles Regarding the Investigation of Healthcare Professionals Due to Medical Procedures and Practices and the Recourse of Compensation Paid by the Administration. In this context:

In relation to the subrogation procedures to be carried out by the administration against healthcare professionals, it is stipulated that the subrogation claims must firstly be directed to the relevant insurance company by defining the scope of the compulsory financial liability insurance, and thus, the insurance company is defined in the regulation. Moreover, it is set forth that the fault rate of the relevant healthcare professional and the condition of remaining within the coverage limit of the insurance policy will be taken as basis in the evaluations regarding recourse.
In order to speed up the internal processes and to encourage digitalisation, it is stipulated that the procedures regarding the investigation permission can be carried out electronically. Other correspondence procedures of the Ministry can continue to be used when necessary.
Regarding the compensation paid by the administration, the Board shall decide within one year from the date of finalisation of the criminal court decision, as to whether or not there will be recourse and if so on the amount of the recourse, taking into account the definitive criminal court decision on whether the person concerned has abused their duty by acting contrary to the requirements of their duty and the rate of fault in the incident in question. As for the healthcare professionals working in state universities; if the Board is of the opinion that the relevant person has acted contrary to the requirements of their duty, it shall make a decision by taking into consideration the definitive criminal court decision, if any. The final decision shall be made by the university within six months following the notification of the Board’s decision to the relevant university.

Amendment to the Social Security Institution Communiqué on Healthcare Practices. On 26 June 2025, the Social Security Institution Communiqué on Healthcare Practices has been amended. In this context:

The rules regarding the invoicing of outpatient examinations and tests performed in the same healthcare facility and within the same specialty after a patient’s discharge have been revised. Accordingly, even if the discharge takes place earlier than the periods defined in the Communiqué, the last day of the relevant period will be considered as the discharge date and examinations and routine biochemical, bacteriological, haematological, cardiological (ECG, ECHO, exertion) and radiological examinations performed within ten days from this date cannot be invoiced separately subject to certain exceptions.
Furthermore, it has been regulated that the procedure points related to blood components can be invoiced separately by healthcare providers at certain rates. These rates have been determined as 36% and 24% for certain procedure codes, and the financial rights of healthcare providers have been clarified with this regulation.
The “List of Reimbursable Medicines” and the “Overseas Medicine Price List,” annexed to the Communiqué have also been updated, and the effective dates have been differentiated on a product basis. For certain medicines in the List of Reimbursable Medicines, the effective date is set as 5 business days after the date of publication, and for others, the effective date is set as 16 May 2025. For medicines without a specified effective date, the new prices will be valid as of the publication date. It is also regulated that the medicines on the Overseas Medicine Price List will enter into force on the date of their publication as well. Thus, with these regulations, dynamic and regular updating of the drug lists has been ensured.

Cosmetics

Announcement Regarding Biocidal Companies. On May 26, 2025, the Agency has published an announcement on its official website regarding an update to the extension of authorization periods for Type 1 biocidal products that come into direct contact with human body, in line with EU legislation. Pursuant to the Commission Implementing Decision numbered 2025/951 dated 22 May 2025 and the Regulation numbered 528/2012 of the European Parliament and the Council (EU), the approval expiry date of the active substance Polyvinylpyrrolidone Iodine (PVP) has been extended to 29 February 2028. Accordingly, it is now possible to apply for “Extension of Authorisation Period” via PTS for products containing the relevant active substance with an authorisation expiry date of 31 August 2025.