Esin / Healthcare & Life Sciences - June 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published (i) the Regulation on Technical Services for Medical Devices Used in the Scope of Health Service Provision, (ii) the Regulation on Clinical Trials of Pharmaceuticals, (iii) the Regulation on the Marketing Authorization of Advanced Therapy Medicinal Products, (iv) the Regulation on Market Inspection of Pharmaceuticals, (v) the Regulation on the National Serial Release, (vi) the Regulation on Health Care Service Provision at Home, (vii) the Guideline on Consultation Procedures Specified in the Medical Device Regulation and (viii) the Regulation on Health Claim Inspection.

The TİTCK also amended (i) the Regulation on Improvement and Evaluation of Quality in Health; (ii) the Regulation on Sale, Advertising and Promotion of Medical Devices; (iii) the Regulation on Marketing Authorization of Pharmaceuticals; (iv) the Regulation on Pharmacists and Pharmacies; (v) the Regulation on Pharmacies and Products Available in Pharmacies; and (vi) the Regulation on Procurement of Pharmaceuticals from Abroad, and announced the First Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products.

First Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products

On 10 May 2023, the TİTCK announced the results of its cosmetics sector market surveillance and inspection conducted in January, February and March 2023.

Of the 115 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 96 were noncompliant and 4 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 414,050 (approximately USD 17,576).

Of the 8 type 1 and type 19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 3 were unlicensed and 4 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 739,640 (approximately USD 31,397).

The 2023 first quarter results for cosmetic products are available here (in Turkish).

The type 1 and type 19 biocidal products’ first quarter results for 2023 are available here (in Turkish).

What Do the Results Say?

The cosmetic products’ safety results reveal that there has been a decrease in the number of inspected products and noncompliant products. In this regard, the total amount of administrative fines has decreased compared to the results for the fourth quarter of 2022.

The type 1 and type 19 biocidal products’ safety results reveal that the number of inspected and unlicensed products has decreased, while the number of unsafe products has increased. Accordingly, there is also a significant increase in the total amount of administrative fines.

Regulation on Improvement and Evaluation of Quality in Health

On 26 May 2023, the Ministry of Health published the Regulation Amending the Regulation on the Improvement and Evaluation of Quality in Health. The main amendments introduced by the Regulation are as follows:

• Health institutions and organizations must conduct self-assessments within the scope of the Turkish Health Quality System. In addition, health institutions and organizations must submit self-assessment results and data on health quality indicators in their area of responsibility to the electronic system created by the Ministry of Health according to the announced schedule.
• Health institutions and organizations must establish a quality management unit that meets the requirements specified in the regulation in order to monitor, evaluate and coordinate quality activities carried out within the scope of quality standards in health. A full-time employee, preferably a manager, must be appointed as a quality management officer in the health institution and organization.
• The Ministry of Health shall carry out assessment and evaluation activities in health institutions and organizations in line with the quality standards in health. The Ministry of Health shall manage the assessment and evaluation process through the electronic system.
• Quality assessments shall be carried out in accordance with the Health Quality Standards Assessment, Evaluation and Rating system published by the General Directorate of Health Services.
• The Ministry of Health shall notify the results of the assessment and evaluation to the health institutions and organizations via the electronic system within 10 days at the latest following the completion of the activity. Health institutions and organizations can file an objection to the evaluation result within 3 working days at the latest from the notification of the evaluation result.
• Health institutions and organizations that obtain accreditation certificates within the framework of internationally accredited standards prepared by the Ministry of Health or its related/affiliated organizations are exempted from health quality assessments during the validity period of the certificate.

The Regulation is available here (in Turkish).

Regulation on Technical Services for Medical Devices Used in the Scope of Health Service Provision

On 26 May 2023, the TİTCK published the Regulation on Technical Services for Medical Devices Used in the Scope of Health Service Provision. The regulation sets out the procedures and principles regarding the technical service activities to be carried out in order to eliminate the risks carried by medical devices and ensure their appropriate and safe use. The main developments introduced by the Regulation are as follows:

• Real and legal persons willing to perform technical service activities for medical devices must apply to the Authority and obtain a technical service activity certificate, a technical manager work certificate and a technical staff work certificate for the employees who will work within the company.
• The technical service activity certificate and technical staff work certificate must clearly state in which device groups and for which devices in these device groups technical service activities can be performed.
• The technical manager must be a full-time employee of the technical service tasked with fulfilling the responsibilities related to its services. The technical manager shall not work for more than one technical service.
• Technical staff is obliged to perform technical service activities in line with the scope of the work certificate and to issue a technical service report regarding these operations. In addition, the technical staff must carry the identity card with a photo issued by the technical service in their name, visible during their work at the health service provider. This identity card must include at least the name of the technical service, the name and surname of the technical staff, and the work certificate number.
• The technical service has the following authorizations:
• To provide basic technical training to the health service provider regarding the device within the scope of its authorization;
• To decide whether this process affects the safety and working performance of the device after the operation of the device in accordance with the manufacturer’s instructions and procedures;
• To contact and inform the health service provider about the maintenance and repair processes of the devices; and
• To give an opinion on the deactivation of devices if requested by the health service provider.
• Modification, update and upgrade activities on the software and hardware of the devices and technical service activities within the scope of the warranty certificate must only be performed by the authorized technical service of the device. If the manufacturer or importer of the device deems it appropriate, modification, update and upgrade activities on the software and hardware of the device can also be performed by the private technical service.

The Regulation is available here (in Turkish).

Regulation on Sale, Advertising and Promotion of Medical Devices

On 26 May 2023, the TİTCK published the Regulation Amending the Regulation on Sale, Advertising and Promotion of Medical Devices. The main amendments introduced by the Regulation are as follows:

• For sales center authorization applications to be made after 1 January 2027, applicants manufacturing medical devices domestically must also submit a document showing that they have established and implemented a quality management system within the scope of the “EN ISO 13485 Quality Management System for Medical Devices” standard issued by a conformity assessment body accredited by an accreditation body authorized under Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance for the marketing of products.
• As of 1 January 2025, sales centers must provide or ensure the provision of basic technical training prior to the first use of the devices they manufacture or import, upon the written request of the relevant healthcare service provider, free of charge and for one time only.
• Sales centers can provide technical service training for the devices they manufacture or import in return for a fee for the lifetime of the device. In addition, sales centers must meet the written requests of the relevant health service provider for basic technical training within 3 months regarding the devices they manufacture or import.
• As of 1 January 2025, except for devices that do not require technical service, sales centers are required to issue a clear, simple and readable warranty certificate in an understandable language for the devices they manufacture or import. The duration of the warranty certificate must be at least 2 years or the value determined by the unit of measurement stipulated by the manufacturer of the device.
• In the implementation of administrative penalty decisions taken by the TİTCK under the Regulation or Law No. 7223, all sales centers that supply the product subject to the penalty to the market and keep it on the market are jointly and severally liable.
• Manufacturers or importers registered in the TİTCK’s registration and information management system without a sales center authorization certificate must obtain the authorization certificate by 26 May 2024.

The Regulation is available here (in Turkish).

Regulation on Clinical Trials of Pharmaceuticals

On 27 May 2023, the TİTCK published the Regulation on Clinical Trials of Pharmaceuticals. In this regard, the Regulation sets out the procedures and principles regarding the conduct of clinical trials of pharmaceuticals and the protection of the rights of volunteers, as well as the establishment, duties, working procedures and principles of the Clinical Trials Advisory Board and ethics committees.

The Regulation is available here (in Turkish).

You can also click here to read our legal alert for further details.

Regulation on the Marketing Authorization of Advanced Therapy Medicinal Products

On 27 May 2023, the TİTCK published the Regulation on the Marketing Authorization of Advanced Therapy Medicinal Products. In this regard, the Regulation sets out the procedures and principles regarding the marketing authorization and pharmacovigilance of advanced therapy medicinal products as well as practices regarding advanced therapy medicinal products that have a marketing authorization.

The Regulation is available here (in Turkish).

You can also click here to read our legal alert for further details.

Regulation on Marketing Authorization of Pharmaceuticals

On 27 May 2023, the TİTCK published the Regulation Amending the Regulation on Marketing Authorization of Pharmaceuticals.

The Regulation is available here (in Turkish).

You can also click here to read our legal alert for further details.

Regulation on Pharmacists and Pharmacies

On 27 May 2023, the TİTCK published the Regulation Amending the Regulation on Pharmacists and Pharmacies. In this regard, newly opened and transferred independent pharmacies must fulfill the obligation to hang the signboard standardized by the Turkish Pharmacists Association as of 27 May 2023.

The Regulation is available here (in Turkish).

Regulation on Market Inspection of Pharmaceuticals

On 1 June 2023, the TİTCK published the Regulation on Market Inspection of Pharmaceuticals. The main developments introduced by the Regulation are as follows:

• The TİTCK shall determine the products and active substances to be included in the market inspection program in line with the determined risk parameters.
• Sampling locations shall be determined from different points in the legal distribution chain of the product using data from the Pharmaceutical Tracking System.
• The marketing authorization holder is responsible for submitting to the National Control Laboratory complete product specifications, analysis methods, method validations and, if necessary, information on storage and transport conditions together with the relevant reference standard substances.
• After the samples delivered to the TİTCK are checked, they must be delivered to the National Control Laboratory for the necessary examinations and analyses. The National Control Laboratory is responsible for examining product samples and preparing analysis reports.
• Based on the evaluation of the analysis results carried out in the National Control Laboratories, the Authority can decide to recall the product in accordance with the Recall Regulation in cases where the products and active substances are found to be noncompliant.

The Regulation is available here (in Turkish).

Regulation on Pharmacies and Products Available in Pharmacies

On 1 June 2023, the TİTCK published the Regulation Amending the Regulation on Pharmacies and Products Available in Pharmacies. The main amendments introduced by the Regulation are as follows:

• Pharmacies cannot employ as a responsible manager for one calendar year a person whose responsible manager certificate has been revoked due to their absence from work during the inspections.
• Domestic manufacturers or companies that have pharmaceuticals with marketing authorization in Türkiye and/or abroad can export their products only within the scope of authorized products through their own companies or authorized companies. Marketing authorization holder companies and exporting companies are jointly and severally liable. In addition, companies can export products for which they do not hold a marketing authorization but which are manufactured domestically under their own trademarks. Companies that will engage in export activities must apply to the Provincial and District Health Directorate until 1 January 2024. Other companies that are already authorized to export pharmaceuticals, provided that they employ a pharmacist as a responsible manager, can apply for a pharmacy permit until 1 January 2024. Companies that have not applied by the specified date or that fail to obtain a Pharmacy Permit by 1 June 2024 shall have their licenses revoked and their activities terminated.

The Regulation is available here (in Turkish).

Regulation on the National Serial Release

On 1 June 2023, the TİTCK published the Regulation on the National Serial Release. The Regulation repealed the Regulation on Serial Release of Vaccines and Immune Serums published in the Official Gazette dated 30 September 2022 and numbered 31969. The main developments introduced by the Regulation are as follows:

• The producer or the natural or legal person authorized on behalf of the producer is responsible for submitting a serial release application for each serial bulk, final bulk or finished product (final lot). A national batch release application must be submitted for each batch of products to be authorized for placing on the market at national level.
• The National Control Laboratory must issue a plasma pool approval certificate for plasma pools used at the national level in the production of blood products by conducting the necessary examinations and inspections.
• The serial release certificate under the TİTCK letterhead must include the nominal dose information in the package for blood products.
• Regulations on domestically produced and/or filled blood products and plasma pools will not be effective until 1 January 2025.

The Regulation is available here (in Turkish).

Regulation on Health Care Service Provision at Home

On 2 June 2023, Ministry of Health published the Regulation on Health Care Service Provision at Home. The main developments introduced by the Regulation are as follows:

• Home health care service refers to medical services that can be provided to individuals who are bed, device or home-dependent due to diagnosed diseases in the place where they live.
• In order to provide home health care services, a home health care unit that has obtained an opening permit from the Provincial Directorate of Health must be established. Subsequently, units that meet the minimum standards for vehicles, medical devices and pharmaceuticals must apply to the Provincial Directorate of Health. The Provincial Directorate of Health must register the unit that it deems appropriate as a result of the on-site inspection and register it in the Home Health Management System.
• Patients and their relatives can apply for home health care services by calling the home health call center and/or through information tools determined by the Ministry of Health. In addition, doctors, family doctors, and those in charge of care and social support services can also create home health requests through software integrated with the Home Health Management System software.
• For procedures requiring a report, home health care services can be provided to patients by visiting the patient on-site and/or through distance health service.
• If deemed appropriate by the doctor and/or requested by the patient, home health care services can be provided remotely in accordance with the provisions of the relevant legislation.
• Staff working in the home health service unit must wear the appropriate standard clothing specific to the service and profession as determined by the Ministry of Health and wear the identification badge indicating their name, surname, title and profession during their duty.

The Regulation is available here (in Turkish).

Guideline on Consultation Procedures Specified in the Medical Device Regulation

On 2 June 2023, the TİTCK published the Guideline on Consultation Procedures Specified in the Medical Device Regulation. As it is known, the Medical Device Regulation sets out consultation requirements in addition to the conformity assessment procedures involving the notified body. In addition, device parts in pharmaceuticals containing medical device parts evaluated under the Regulation on the Marketing Authorization of Pharmaceuticals must comply with general safety and performance requirements. In this regard, the Guideline has been prepared in order to provide information to manufacturers and notified bodies on the different combinations of pharmaceuticals and medical devices, the classification of these product groups, and which regulations they are subject to, to provide guidance on the general principles regarding the relevant consultation procedures and to determine the procedures and principles regarding the request for scientific opinion.

The Guideline is available here (in Turkish).

Regulation on Procurement of Pharmaceuticals from Abroad

On 3 June 2023, the TİTCK published the Regulation Amending the Regulation on Procurement of Pharmaceuticals from Abroad. The amendments are effective as of 3 May 2023. The main amendments introduced by the Regulation are as follows:

• Foreign pharmaceutical suppliers are required to submit to the TİTCK a contract signed with a secondary packaging facility authorized by the TİTCK under the Regulation on Manufactories for Pharmaceuticals by 31 July 2023.
• Foreign pharmaceutical suppliers must meet their traceability and record-keeping obligations for pharmaceuticals in their stocks by 31 August 2023.

The Regulation is available here (in Turkish).

Regulation on Health Claim Inspection

On 13 June 2023, the TİTCK published the Regulation on Health Claim Inspection. The Regulation repealed the Regulation on Health Declarations of Products Offered for Sale with Health Declarations published in the Official Gazette dated 7 June 2013 and numbered 28670. The main developments introduced by the Regulation are as follows:

• Without prejudice to the provisions of special legislation on products, health claims cannot be used in products other than food and food supplements. In promoting products, it must not be stated, asserted or implied that the components of a product are directly or indirectly beneficial to human health, are effective against diseases or their symptoms, or protect or treat them.
• In cases where the product is promoted electronically, the name, title and contact information of the product owner must be included on the website where the promotion is made.
• The product owner and the promoter are jointly responsible for the health claims made about the products.
• In cases where the product is promoted electronically, intermediary service providers are obliged to correct, remove or block access to the content of product promotion and/or sales made using health claims contrary to the relevant legislation upon request by the TİTCK.

The Regulation 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

Tagged with: Esin Attorney Partnership, Can Sözer, Yiğit Acar, Ayça Doğu Öztürk, Gizem Nur Giacomini, Berk Furkan Derici, Life Sciences, Healthcare