The Ministry of Health (“Ministry”) recently published the Regulation on Private Hospitals, and the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) published the Announcement on Marketing Authorization Applicants.
Regulation on Private Hospitals
On 30 January 2025, the Ministry published the Regulation on Private Hospitals (“Regulation”) and repealed the Regulation on Private Hospitals dated 27 March 2002. The Regulation applies to hospitals owned by real or legal persons, with the exception of oral and dental hospitals. The main amendments introduced by the Regulation are as follows:
- Private hospitals will be required to meet the physical conditions set forth in Annex 5 of the Regulation by 31 December 2025. Deviations of up to 2% will be allowed in the measurements related to the established minimum physical standards.
- In line with the planned number of doctors and service needs according to the health service regions determined by the Ministry, private hospitals with between 50 and 100 patient beds can be opened.
- Private hospitals will obtain an accreditation certificate from the Turkish Institute of Health Services Quality and Accreditation (“TÜSKA”) within 3 years of their licensing. Private hospitals that have been licensed and operating before 30 January 2025 will obtain an accreditation certificate from the TÜSKA within 3 years at the latest. Hospitals that do not have an accreditation certificate will display a sign stating, “This hospital does not have a TÜSKA accreditation certificate” and place it somewhere that is visible to patients.
- Private hospitals are not allowed to be opened in the name of (i) real persons who have been convicted for 5 years or more or who have committed crimes against the security of the state, crimes against the constitutional order and its functioning, embezzlement, extortion, bribery, theft, fraud, forgery, abuse of trust, fraudulent bankruptcy, bid rigging, laundering or smuggling of assets derived from crime or crimes against sexual inviolability, or (ii) real persons who are banned from public work. In addition, private hospitals cannot be opened if their legal persons have these persons in their partnership structure. These persons cannot assign a private hospital license and cannot take part in the partnership structure of legal persons that have a private hospital license in their name.
- Real and legal persons whose licenses have been canceled will not be issued new private hospital licenses in their name for 5 years.
- In the event of a change in the shareholding structure of real persons in whose name a private hospital license is issued, the General Directorate of Health Services must be notified of such change within 1 month at the latest. This notification obligation will not be required for legal persons that have been listed for IPO.
- Planning conformity certificates will be issued for new hospital openings and for existing hospitals whose requests for a specialty center, unit, medical device, specialist physician staff or bed capacity changes are deemed appropriate as a result of the plans to be announced by the Ministry regarding health services. Planning conformity certificates cannot be assigned.
- A hospital that has been issued a planning conformity certificate will be required to obtain prior permission within 2 years for the change to the specialty center, unit, medical device or bed capacity. If prior permission has not been obtained within 2 years, the planning conformity certificates for these private hospitals will be canceled.
- A prior permission certificate cannot be assigned. However, prior permission certificates issued as of 30 January 2025 may be assigned once before 31 December 2025, provided that they are in line with the Ministry's planning. If licensed and operating private hospitals with a prior permission certificate issued for relocation purposes assign their licenses, the prior permission can remain on behalf of the new license holder, while preserving its current term.
- A license will need to be obtained within 3 years from the date of the prior permission certificate. If the license has not been obtained at the end of this period, the prior permission certificate will be canceled. However, those who cannot apply for a license because they have not completed the building by the end of the licensing period and they do not have a visa above the base obtained from the respective local administration will be given an additional 2 years.
- With the Ministry's permission, private hospitals will only be able to move or merge within the province where they are located. Merged private hospitals will not be able to separate afterwards.
- If a private hospital is assigned, the acquired hospital cannot be reassigned for 2 years.
- The General Directorate of Health Services will be notified if there are any changes to the issues included in the license and activity permit of private hospitals. The notified changes will be assessed by the Ministry, and the license and activity permit will be reissued. In addition, if a private hospital's address information is changed by the relevant municipality, a new license and operation permit will need to be issued.
- Private hospitals will have at least one emergency ambulance under their ownership or through a service agreement until 1 January 2026..
- Titles of private hospitals must be appropriate for the purpose of service and must not violate public order and public morality, subject to the Ministry's approval.
- Consent forms indicating consent to accept treatment to be administered can be signed via an electronic or wet signature.
- In private hospitals, patient rooms, outpatient clinics and waiting rooms will have a QR code where patients can provide feedback integrated with the “Ministry of Health Communication Center”.
- Private hospitals will be audited when necessary to ensure that the healthcare services provided comply with the medical indications or practices determined by the Ministry for the use of a specific medical procedure. Medical indication and practice audits will be conducted through patient files, electronic recording systems, medical photographs, medical imaging, reports and other relevant information and documents, either through the e-audit system or on-site.
- The General Directorate of Health Services or provincial or district directorates will report on audit results, which will be processed with the approval of the Ministry if it is deemed appropriate. Judicial and administrative proceedings may be initiated according to the audit result report.
- If urgent and irreversible situations arise during the inspections that adversely affect the treatment of patients in a part or all of the private hospital, jeopardize patient health and safety if the service continues and require immediate cessation of the service without delay, the activity will be suspended in the relevant unit or in the entire private hospital until the deficiency is remedied, provided that this situation is certified and justified in the inspection detection report.
- Except for radiology and medical laboratory examination services for which service procurement is permitted, clinical services in the specialties included in the hospital operating license will not be performed by third parties.
- Private hospitals will not be allowed to operate in a place other than the licensed building.
- If the deficiencies identified during inspections of private hospitals are not remedied within the period given, the deficiencies must be remedied within 6 months after the temporary suspension of operation in part or in whole. Otherwise, the hospital's license will be canceled.
The Regulation is available here (in Turkish).
Announcement on Marketing Authorization Applicants
On 30 January 2025, the TİTCK published the Announcement on Marketing Authorization Applicants (“Announcement”). The Announcement states that, pursuant to the Regulation Amending the Regulation on the Marketing Authorization of Pharmaceuticals dated 3 December 2024, if the active substance in the composition of products is supplied domestically, the signed supply agreement and invoice between the active substance supplier and the marketing authorization applicant must be submitted in the marketing authorization application; if it is supplied from abroad, the letter of conformity issued in accordance with the relevant guideline published by the TİTCK must be submitted in the marketing authorization application.
The Announcement clarifies that for active substances imported as of 30 January 2025, the guideline referred to is the Guideline on Import Applications and Marketing Authorization (“Guideline”), and the respective letter of conformity is the invoice annotation approval set forth in the Guideline. In addition, the Announcement clarifies that active substances imported before 30 January 2025 that lack invoice annotation approval, the relevant letter of conformity is the letter issued by the Department of Medicine Drug Use based on the application made by the importers to the Department of Rational Medicine Use, Import and Market Supply Unit.
Furthermore, for joint marketing applications, a customs exemption letter for importing the active substance of the main product, or the import feedback tracking number for the import of products for which there is no customs exemption letter and a screenshot of the approved feedback form, will need to be submitted.
The Announcement 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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
