Circular on Medical Devices
TİTCK published the Circular No. 2022/1 on Medical Devices on 20 September 2022. The Circular has been prepared in order to effectively implement the Medical Device Regulation and the Regulation on In Vitro Diagnostic Medical Devices, to clarify the issues regarding the new regulations and to inform the sector.
The Circular contains explanations on (i) the obligation for economic operators to employ at least one personnel as a compliance officer, (ii) the obligation to register in the European Database EUDAMED and (iii) the additional obligations imposed on importers and distributors regarding the labeling and repackaging of medical devices.
The circular is available here (in Turkish).
Guideline on Applications for Good Manufacturing Practices (GMP) Audits of Foreign Production Facilities
TİTCK updated the Guideline on Applications for GMP Audits of Foreign Production Facilities on 20.09.2022. In this regard, the principles regarding GMP audit applications and audit scope have been expanded and detailed explanations on the provisions to be applied in crisis and emergency circumstances have been introduced. Furthermore, additional provisions regulating audits through file have been introduced
Accordingly, applications made before the publication date of the Guideline will be evaluated in accordance with the previousGuideline, and applications made after the publication date will be evaluated in accordance with the new Guideline.
In addition, the announcement dated 03.12.2021 on Additional Measures to be Implemented During the Pandemic on GMP Audits and Certification Processes Abroad remains valid. The relevant announcement is available here (in Turkish)
The Guideline is available here (in Turkish)
Guideline on Application for Medicinal Products for Human Use Facilities
TİTCK published the Guideline for the Application for Medicinal Products for Human Use Facilities on 24 September 2022. The Guideline aims to provide guidance on the form, content and process of applications to be submitted to the TİTCK by manufacturers of (i) medicinal products for human use, including clinical trial products which wish to obtain an operating license from the TİTCK or have already obtained such license, and (ii) their active ingredients and (iii) production facilities of dietary foods for special medical purposes.
Accordingly, the Guideline leads the stakeholders on many issues such as opening application, permit, additional activity certificate permit update, responsible manager, key personnel change, facility master file preparation and facility closure.
The Guideline is available here (in Turkish).
Guideline on Application for Places Evaluated under Good Distribution Practices (GDP)
TİTCK published the Guideline on Application for Places Evaluated under Good Distribution Practices (GDP) on 24 September 2022
The Guideline covers the form, content and process of applications to be submitted to the TİTCK by pharmaceutical businesses and transfer centers engaged in the storage and distribution of medicinal products for human use. In this regard, the Guideline provides detailed guidance on various processes such as opening/transfer application, obtaining, updating or renewing authorization certificate, obtaining GDP certificate, obtaining authorization certificate for the responsible manager and the responsible personnel, and making a closing application.
The Guideline is available here (in Turkish).
Announcement on the Conditions for Appointment as a Reference Laboratory under the Regulation (EU) No. 2017/746 on In Vitro Diagnostic Medical Devices
The TİTCK published the Announcement on the Conditions for Appointment as a Reference Laboratory under the Regulation (EU) No. 2017/746 on In Vitro Diagnostic Medical Devices on 26 September 2022. Pursuant to Article 98 of the relevant Regulation, TİTCK may propose to the EU Commission laboratories that apply and meet the necessary criteria to be appointed as EU Reference Laboratories for certain medical devices.
In this regard, institutions willing to operate as EU Reference Laboratories will be able to apply to the TİTCK via the Electronic Information Management System (EBYS) with a cover letter in Turkish and English and other forms in English until 05.01.2023 at 12:00 in line with the conditions set by the European Commission. After the application, the relevant institutions should send a notification to the e-mail address "md.nb@ titck.gov.tr" which indicate that the application is made. In addition, the application documents must be physically submitted to the TİTCK.
It was informed that the applications will be pre-evaluated by the TİTCK in accordance with the Commission's criteria and then forwarded to the Commission. In any case, it was stated that it was the responsibility of the Commission to make the final assessment and decision.
In addition, the documents to be considered or forwarded within the scope of the application are attached to the announcement.
The Announcement is available here (in Turkish).
Regulation on Private Health Institutions Providing Oral and Dental Health Services
The Regulation on Private Health Institutions Providing Oral and Dental Health Services has been published on 6 October 2022 and entered into force through its publication. The main amendments introduced by the Regulation are as follows:
- The conditions for opening clinics, polyclinics, centers and hospitals to provide oral and dental health services have been determined. Accordingly, a dentist who is a citizen of the Republic of Türkiye may be a responsible manager in a health institution providing oral and dental health services. The responsible manager will be responsible for all operations related to the activity and supervision of the health institution.
- In order to open a health institution providing oral and dental health services, it is necessary to obtain a preliminary permit, a license and an operating permit. These applications will be made to the Local Health Authority together with the documents specified in the Regulation.
- Medical interventions other than oral and dental health services cannot be performed in health institutions providing oral and dental health services.
- Data on patients admitted to health institutions should be recorded electronically. The recorded health data should be processed and transferred to the central health data system according to the procedures and principles determined by the Ministry of Health in accordance with the Law No. 6698 on the Protection of Personal Data and secondary regulations and Article 378 of the Presidential Decree No. 1 on the Organization of the Presidency.
- Health institutions providing oral and dental health services will be subject to regular audits at least once a year by the auditing team established by the Local Health Authority, except for extraordinary audits made upon complaint or denunciation
The regulation is available here (in Turkish).
Amendments on Regulation on Private Hospitals
The Regulation Amending the Regulation on Private Hospitals has been published by The Ministry of Health on 6 October 2022 and entered into force through its publication. The main amendments introduced by the Regulation are as follows:
- Hospitals operating in the specialty of oral and dental health are excluded from not being subject to the obligation to have an intensive care unit under this regulation.
- Doctors who have a clinic should be able to diagnose and treat their patients in private hospitals, on condition that the service fee is covered by the patient and not requested from the Social Security Institution. In addition, the patient must be informed at the clinic that the costs of treatment at the private hospital will be covered by the patient and the subject and results of the medical intervention, and the patient's information must be sent to the private hospital where the patient will be treated through the Practice Information Management System (MBYS) in the form specified by the Ministry.
- In order for the diagnosis and treatment of clinic patients to be performed in a private hospital, there must be an annual contract between the doctor and the hospital, and the hospital must have a vacant specialist doctor staff in the relevant branch. If private hospitals do not have a vacant specialist doctor staff, they may sign a contract with up to 15% of the total number of specialist doctors in the specialist doctor branches registered in their license and/or activity permit. If it is intended to sign a contract with more than one doctor in the same branch, a contract cannot be signed with more than one third of the total number of staff in the relevant branch.
- The responsible manager of the private hospital providing services to doctors who have a clinic must report the number of patients treated and the name of the doctor to the Local Health Authority at the end of each month.
- A graduated sanction system has been introduced, which will be applied in case of violation of the procedures and principles regarding the diagnosis and treatment of the clinic patient in a private hospital and may lead to the suspension of the activity of the clinic for a certain period of time.
The regulation is available here (in Turkish).
Amendments on Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment
The Regulation on the Amendment of the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment has been published by The Ministry of Health on 6 October 2022 and entered into force through its publication. The main amendments introduced by the Regulation are as follows:
- The informed consent form for clinic patients before outpatient or inpatient treatment in the medical center must be signed by the patient or his/her legal representative, the clinic doctor, the relevant unit responsible of the private health institution and the responsible manager.
- A copy of the contract with the clinic doctor, signed by both parties, must be sent by the medical center to the Provincial Health Directorate. These contracts must be submitted to the Provincial or District Health Directorate until the end of the third month following the effective date of the amendment.
- The responsible manager of the medical center providing services to doctors who have a clinic must report the number of patients treated and the name of the doctor to the Provincial or District Health Directorate at the end of each month.
- A graduated sanction system has been introduced, which will be applied in the case of violations by the medical center and the clinic doctor of the procedures and principles introduced regarding the diagnosis and treatment of the clinic patient in the medical center and may lead to the suspension of the activities of the relevant institution for a certain period of time.
The regulation is available here (in Turkish).
Amendments on Decree on the Pricing of Medicinal Products for Human Use
The Presidency of Republic of Türkiye published The Decree on the Amending the Decree on the Pricing of Medicinal Products for Human Use. The relevant decree which entered into force on 12 October 2022 amend the profit rates of the warehouse keeper and pharmacist applied while determining the retail sales price in the Decree on the Pricing of Medicinal Products for Human Use. The main amendments introduced by the Decree are as follows:
- The pharmacist profit rates to be applied when determining the
retail price of products other than medicines have been amended as
follows;
- 28% for the amount up to 200 TRY (including 200 TRY),
- 18% for the part between 200-400 TRY (including 400 TRY),
- 13% for the part over 400 TRY
The Decree is available here (in Turkish).
Conclusion
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK's announcements and take 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.
