Recent Developments in Healthcare Legislation

Table of Contents:

Medicinal Products for Human Use

• New Guideline on the Applications for GMP Inspections of Foreign Manufacturing Facilities
• Guideline on the Issuance of Pharmaceutical Product Certificate, Free Sale Certificate and Health & Free Sale Certificate Documents

Healthcare Services

• Recent Developments in Healthcare Services
• Law on Amendments to Certain Laws Related to Health and Decree-Law No. 663
• Regulation on Amendments to the Regulation on the Job and Duty Descriptions of Healthcare Professionals and Other Professionals Working in Healthcare Services
• Regulation on Amendments to the Regulation on the Independent Practice of Healthcare Professionals
• Regulation on Amendments to the Organ Transplantation Services Regulation
• Amendment to the Circular on the Procedures and Principles Regarding Institutional Contributions to Compulsory Financial Liability Insurance for Medical Malpractice
• Regulation on Products Derived from Human Tissues and Cells and the Centres Related to These Products
• Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Implementations

Medicinal Products for Human Use

New Guideline on the Applications for GMP Inspections of Foreign Manufacturing Facilities. The Guideline on the Applications for GMP Inspections of Foreign Manufacturing Facilities has been updated by the Turkish Medicines and Medical Devices Agency (“Agency“), and the new guideline has entered into force on 22 September 2025. In this context, applications submitted before 24 September 2025 will be evaluated according to the previous version, whilst applications submitted on or after 24 September 2025 will be evaluated in accordance with the provisions of the new guideline.

A special transitional arrangement has been introduced for the inspection and GMP certification process of foreign manufacturing facilities designated in the marketing authorisations of products authorised before 2010 that have not been previously inspected by the Agency and do not hold a GMP certificate. Within this scope, for facilities that have not been inspected by the Agency but have previously applied for an on-site inspection, a one-off exceptional dossier-based assessment has been granted, provided that an application is submitted by 31 December 2025. In this exceptional assessment, a decision from the Priority Evaluation Board will not be required. Applications for facilities that have previously been inspected and approved as compliant by the Agency will be made as per the provisions of the guideline.

Under the provisions of the new guideline:

• For applications based on on-site inspections conducted in 2016 or later, the right to request risk-based inspections has been expanded for manufacturing facilities located in countries that are members of the Pharmaceutical Inspection Cooperation Scheme (“PIC/S”). If the relevant facilities are located in a PIC/S member country, the maximum validity period of an inspection is 12 years, and up to three risk-based inspection requests may be submitted for facilities in these countries. For facilities located in non-PIC/S member countries, the validity period is 9 years, and a maximum of two risk-based inspection requests may be submitted for facilities in those countries.
• For certain products, the extension period has been prolonged for the validity of existing GMP certificates of the facilities which, following the Agency’s evaluation upon a dossier-based inspection or risk-based inspection, are decided to undergo an on-site inspection, or which have already exercised their right to two or three risk-based inspection requests. In this context, provided that a current and valid GMP certificate issued by the relevant authorities of PIC/S member countries for the facility is submitted and upon evaluation of applications made with the Foreign Good Manufacturing Practices (GMP) Notifications document type, the validity period of the existing GMP certificates may be extended for up to 12 months from the expiry of the validity date, on a one-time basis.
• A provision has been introduced governing requests for the subsequent inclusion in the GMP certificate of non-mandatory activities that were not subject to inspection during the on-site inspection and were therefore not reflected in the issued certificate. In this context, a decision will be made based on the evaluation of an application to be submitted under the document type Foreign Good Manufacturing Practices Notifications, along with the local authority report covering the relevant activities, the report issued by the competent authorities in PIC/S member countries, the manufacturing site license, and the facility’s current GMP certificate documents.

Guideline on the Issuance of Pharmaceutical Product Certificate, Free Sale Certificate and Health & Free Sale Certificate Documents. The new guideline, which entered into force on 15 October 2025, repealed the Guideline on the Issuance of Pharmaceutical Product Certificate, Free Sale Certificate and Pharmaceutical Product Marketing Authorisation Status Statement Documents dated 21 October 2022. Under the new guideline, considerations for applications for Pharmaceutical Product Certificate, Free Sale Certificate and Health & Free Sale Certificate have been separately regulated. With the new guideline, the “Pharmaceutical Product Marketing Authorisation Status Statement” document included in the previous version has been removed and replaced with the “Health & Free Sale Certificate” document. Within the scope of the amendments, new practices have been introduced regarding the matters to be considered in the relevant certificate applications. For example, an individual application must now be submitted for each country in respect of pharmaceutical product certificate and free sale certificate applications. It has been specified that, when providing information regarding the availability status of the product on the Turkish market in pharmaceutical product certificate applications, the manufacturer-to-hospital, manufacturer-to-pharmacy, warehouse-to-hospital, warehouse-to-pharmacy, pharmacy-to-Social Security Institution, pharmacy-to-patient (over the counter), or other pharmacy transactions within the last 1 year in the Drug Tracking System (ITS) will be taken into consideration. It has been made mandatory to make a separate application for each certificate, country, and product within the scope of the Health & Free Sale Certificate, which is defined under the guideline as a document showing that foods for special medical purposes are not harmful to human health, are suitable for human consumption, and are approved for free sale in the exporting country; to select the product name in the electronic system; and to use the term “Türkiye”. Under the new guideline, the relevant applications and the preparation of the information and documents submitted to the Agency may be carried out either directly by the applicant or by person(s)authorized by the applicant. However, it is explicitly stated that in the event of any change in the information included in the applications and approved by the Agency, the certificate will no longer be valid and cannot be used in any transactions.

Healthcare Services

Recent Developments in Healthcare Services. On 11 November 2025, the Regulation on Licensing of Healthcare Services was published in the Official Gazette, followed by the Regulation on Promotion and Information Activities in Healthcare Services and the Regulation on Obesity Units and Obesity Surgery Implementation Units on 12 November 2025, which entered into force on their respective publication dates. Further information regarding these regulations can be found in the announcement we published on 13 November 2025: Recent Developments in Healthcare Services

Law on Amendments to Certain Laws Related to Health and Decree-Law No. 663. Upon publication of the Official Gazette dated 24 July 2025, amendments to Certain Health-Related Laws have been introduced:

• Amendments to Law No. 2313 on the Control of Narcotic Substances:
  • • The cultivation of cannabis has been expanded beyond the previous limitation to production of active pharmaceutical ingredients, and is now included within the scope of the production of medicinal products, health products, personal care and support products.
  • The Ministry of Agriculture and Forestry has been designated as the responsible ministry for cultivation and harvesting, while the Ministry of Health (“Ministry“) has been designated as the responsible ministry for processing, licensing, and sales. Accordingly:
    • Licensing or registration procedures for medical products, health products, personal care products, and support products derived from cannabis will be carried out by the Ministry. The procedures and principles regarding the authorisation and sale of these products, as well as the processing, storage, and export of cannabis, will be determined by regulations issued by the Ministry, taking into account the opinions of the Ministry of the Interior and the Ministry of Agriculture and Forestry.
    • The processes related to the cultivation and harvesting of cannabis will remain within the remit of the Ministry of Agriculture and Forestry. While the previous regulation defined a broad area of authority relating to “the harvesting, processing, prepare, export or sale of cannabis“, the new regulation narrows this down to “the cultivation and harvesting of cannabis“.
  • It is envisaged that the products will be sold only in pharmacies and will be placed on the market under supervision.
• Amendments to Law No. 1219 on the Practice of Medicine and Related Professions:
  • Physicians, dentists and specialists will now be able to work in a maximum of two healthcare institutions. Physicians currently working in private healthcare institutions or foundation universities must apply in accordance with the new regulations by 1 June 2026. Otherwise, their current permits will be revoked.
  • Physicians working in private healthcare institutions and foundation universities will be considered as insured employees, even if they have contracts with the Social Security Institution or public institutions.
  • Physicians and dentists will now also be able to obtain the necessary consent from patients for any type of surgery electronically, meaning that patients will be able to provide consent via electronic devices or online communication platforms. Identity verification procedures will be carried out through biometric recognition methods or official electronic identity systems, and the technical specifications of the system will be determined jointly by the Ministry and the Information and Communication Technologies Authority.
• Amendments to the Pharmaceutical and Medical Preparations Law No. 1262:
  • License or permit holders are obliged to report all movements of human medicinal products and special medical-purpose foods within the supply chain to the tracking system in accordance with the procedures and principles determined by the Ministry. Those who act in violation of this obligation will be subject to an administrative fine equal to twice the total wholesale prices of all products subject to the non-compliance as of the date on which the violation is identified. In case of a recurrence of the same act within one year, the administrative fine will be applied with a one-fold increase.
• Amendments to the Health Services Fundamental Law No. 3359:
  • Private healthcare institutions will now only be able to provide general health information regarding their address, contact details, working hours, areas of expertise, and the professional titles of their staff. In this context, private healthcare institutions are prohibited from engaging in advertising activities that exceed the limits of promotional and informational activities provision. Those who fail to comply with these rules will be subject to administrative fines starting from TRY 100,000 and reaching up to 2% of gross service revenue.
  • Institutions distributing or using counterfeit medical devices may be fined between TRY 1,000,000 and TRY 10,000,000 for the year 2025. Those providing unauthorised advertising, distribution or technical service will be fined between TRY 500,000 and TRY 5,000,000 for the year 2025.
  • The Agency is authorised to request any financial records and documents from individuals and legal entities for inspection purposes.

Regulation on Amendments to the Regulation on the Job and Duty Descriptions of Healthcare Professionals and Other Professionals Working in Healthcare Services. Under this regulation, which came into force on 6 September 2025, the scope of duties of (i) anaesthesia technicians/technologists, (ii) dental prosthesis technicians, (iii) healthcare technicians, and (iv) nuclear medicine technicians has been amended. Within the scope of the amendments, the job descriptions of the relevant technicians have been expanded to include measures that enhance patient safety, such as the safe initiation, continuation, and termination of anaesthesia procedures, or the calibration and inspection of equipment and instruments prior to use. Furthermore, the provisions relating to mammography technicians, nursing assistants, and midwifery assistants have been repealed.

Regulation on Amendments to the Regulation on the Independent Practice of Healthcare Professionals. Within the scope of the relevant amendments, workplaces where health professionals operated under various titles prior to 15 August 2025, are required to be brought into compliance with the legislation, and licensed no later than 31 December 2025. In this context, (i) a title deed or a copy of the lease agreement, (ii) a scaled floor plan documenting the physical structure and intended use of the health professional unit’s activity area, (iii) a document from the competent authority confirming that the necessary fire safety measures have been taken in accordance with the relevant legislation for the section where the healthcare unit is located, (iv) a building occupancy permit for the building where the health professional service unit will be established, and (v) a medical waste report prepared in accordance with the relevant legislation for midwives, nurses, and podiatrists and the contract concluded with the relevant institution for the disposal of medical waste are enumerated as documents required for the service building of the health professional service unit.

Regulation on Amendments to the Organ Transplantation Services Regulation. Within the scope of the amendments that entered into force on 26 September 2025, the principles to be applied to donation declarations made electronically and stored by the Ministry in accordance with the Personal Data Protection Law No. 6698 regarding deceased organ donation procedures are set out in this regulation. Accordingly, the person making the donation declaration may designate or list their spouse, children of legal age, mother or father, or one of their siblings, or, if none of these exist, any other close relative, to express their will regarding organ donation after their death. If the will of the designated person conflicts with that of the deceased’s other relatives, the will of the designated person shall prevail. In cases where the person has not made any declaration regarding organ donation, it is stipulated that organs or tissues may be taken from the deceased with the consent of, in order of priority, their spouse, children of legal age, mother or father, or one of their siblings present at the time of death, or any other relative present if none of the above are available.

Amendment to the Circular on the Procedures and Principles Regarding Institutional Contributions to Compulsory Financial Liability Insurance for Medical Malpractice. On 7 August 2025, an amendment has been introduced to the Circular on the Procedures and Principles Regarding Institutional Contributions to Compulsory Financial Liability Insurance for Medical Malpractice (2010/1). Accordingly, the maximum coverage limits have been set at TRY 1,000,000 for Group I, TRY 2,000,000 for Group II, TRY 3,000,000 for Group III, and TRY 4,000,000 for Group IV. The total maximum contract amount is TRY 9,000,000. The insurance premium amounts corresponding to these guarantees have also been increased, and are set at TRY 750 for Group I, TRY 1,500 for Group II, TRY 2,500 for Group III, and TRY 3,750 for Group IV. This regulation has entered into force on 1 November 2025, and the Insurance and Pension Regulation and Supervision Authority is responsible for its implementation.

Regulation on Products Derived from Human Tissues and Cells and the Centres Related to These Products. The Communiqué on the Repeal of the Communiqué on the Licensing of Human Tissue and Cell Products and Centres Conducting the Production, Import, Export, Storage and Distribution Activities of These Products published on 4 September 2025, has repealed the Communiqué on the Licensing of Human Tissue and Cell Products and Centres Conducting the Production, Import, Export, Storage and Distribution Activities of These Products, which was published in the Official Gazette numbered 28962 and dated 4 April 2014. Furthermore, with this amendment, the Regulation on Products Derived from Human Tissues and Cells and Centres Related to These Products was published on 4 September 2025 and will enter into force on 1 January 2026.

The regulation governs all stages involving human-derived tissues and cells, from donation through to their application to the patient. Within this scope, the regulation sets out the procedures for procurement, testing, processing, preservation, storage, distribution, disposal, transportation, import and export, as well as the obligations of the centres responsible for conducting these activities. The scope further extends to biobanking practices, the processing and storage of cells used in assisted reproductive techniques, the storage of bone marrow–derived stem cells, and cornea banking activities. By contrast, bone marrow transplantation centres, blood and plasma products, organ and composite tissue transplantation, the licensing of assisted reproductive treatment centres, tissues of animal or synthetic origin, and activities conducted solely for scientific research purposes are excluded from the scope of this regulation.

Under the regulation, the Directorate General of Health Services, Agency, and the Turkish Health Institutes Presidency (“Presidency”) are designated as the competent authorities. To ensure coordination among these institutions, a Tissue and Cell Coordination Centre will be established within the Presidency, which will be vested with centralized record-keeping and logistics management responsibilities for procurement and distribution processes.

Centres falling within the scope of the regulation are classified into three main categories: (i) tissue–cell source centres, (ii) tissue–cell centres, and (iii) human application centres. Different authorization, licensing, and inspection procedures are stipulated for each type of centre; however, in all cases, centres will be inspected at least once a year and will be subject to extraordinary inspections when necessary. In the event that unlicensed activity is identified, operations will be halted immediately, and a criminal complaint will be filed. If, during inspections, it is determined that centres are engaged in activities that are in violation of the provisions of this regulation, the centre’s authorization/license or some or all the permitted activity types listed in the license may be suspended or revoked, provided that such violation is documented in the inspection report. As a principle, the donation process is voluntary and non-remunerated. Detailed procedures have been established regarding informing and obtaining consent for the retrieval of tissues or cells from living or deceased. Timelines for family interviews have been determined, and storage rules have been clarified.

Quality management, traceability, and data retention obligations are defined in a comprehensive manner. Quality system documentation must be retained for at least ten years, while all required information, including records relating to donors, recipients and products, must be preserved for a minimum of thirty years from the date of clinical use or expiry, in full compliance with data privacy and data security legislation. It is stipulated that at least one reference sample for each product placed into permanent storage or transferred for clinical use must be retained for a period of two years. In addition, a national data registration and monitoring system will be established to ensure that all processes are recorded and monitored in a digital environment.

Under the regulation, operating without a license, making unauthorized modifications, and issuing promotional or expectation-raising statements are prohibited; and centres may not engage in donation, procurement, processing, distribution, import or export activities without obtaining the necessary authorization. Advertising regarding human tissues and cells through television, print media, or social media is not permitted; misleading statements, claims lacking a scientific basis, or expressions that create unjustified expectations in patients may not be used; donors may not be provided with financial gain, and no announcements may be issued regarding the need for tissues or cells. The transfer of tissues or cells abroad or into the country is not permitted without obtaining permission from the competent authority. Depending on the nature of the violation, administrative and judicial sanctions will be imposed pursuant to the Turkish Criminal Code, Law No. 3359, and other relevant legislation.

Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Implementations. The regulation, which has been published and entered into force on 24 October 2025, governs the establishment, licensing, operation, and supervision principles for all medical laboratories and genetic centres, and advanced technology laboratories and R&D laboratories have also been included within the scope. In this context, the key provisions of the said regulation are as follows:

• Individuals or institutions seeking to establish a new laboratory must first conduct a compliance assessment in line with the Ministry’s planning and obtain a preliminary permit. The preliminary permit will remain valid for two years, during which the licensing application must be duly completed. Otherwise, the preliminary permit will be cancelled. Applications submitted prior to the effective date of the Regulation will be finalised in accordance with the provisions of the repealed Regulation on Medical Laboratories and the Regulation on Genetic Disease Evaluation Centres.
• Laboratories have been classified into five main categories according to their service scope and activities: (i) biochemistry, (ii) microbiology, (iii) pathology, (iv) genetics, and (v) tissue typing. For each category, supervised, comprehensive, reference, and national-level laboratory types have been defined.
• The use of artificial intelligence and decision support systems has been included within the scope of the legislation. Rules regarding the integration, validation and distribution of responsibility of these systems have been regulated in detail.
• Participation in internal and external quality control programs has been made mandatory, and external quality control providers are required to hold ISO/IEC 17043 accreditation. Programs that do not hold an accreditation certificate may be accepted only if they are evaluated by the Medical Laboratories Scientific Commission and deemed as appropriate by the Ministry.
• Compliance with biosafety, occupational health and safety, waste management, and personal data protection requirements in medical laboratories/centres is also regulated in detail under the regulation.
• The duties of the responsible manager and unit supervisors have been clearly defined, and laboratories have been obligated to maintain an adequate and competent workforce.
• Providing services without a license, conducting tests with non-validated kits produced solely for research purposes, unethical practices, and false reporting are prohibited. If a deficiency is identified that may adversely affect human health, the activities of the medical laboratory or centre shall be suspended by the relevant governor’s office upon the Ministry’s decision until such deficiency is remedied.
• A medical laboratory/centre that continues its activities while its service has been temporarily suspended partially or completely shall be subjected to a complete suspension of activities for twice the original suspension period. In cases where the medical laboratory or centre continues its activities despite this doubled suspension period, its license/activity permit shall be cancelled by the Ministry.