Healthcare & Life Sciences Newsletter - December 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training, and the Guideline on Conditions for Exports Except to Pharmacies. The TİTCK also amended: (i) the Decree on the Pricing of Pharmaceuticals; (ii) the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices; (iii) the Regulation on Variations in Pharmaceuticals with Marketing Authorization; (iv) the Regulation on the Marketing Authorization of Pharmaceuticals; and (v) the Regulation on Clinical Trials of Pharmaceuticals.

Guideline on the Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training

On 12 December 2023, The TİTCK published the Guideline on the Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training. The Guideline has been prepared to instruct the responsible person, responsible technical personnel and safety assessors about providing information on the requirements to be included in the cosmetic product information file and the training programs to be organized for the responsible persons who will carry out safety assessments. The main amendments introduced by the Guideline are as follows:

• A cosmetic product on the market shall be considered safe for human health when used under normal or reasonably foreseeable conditions of use, taking into account the presentation, labeling, instructions and disposal of the product in accordance with consumer legislation and any other data or information provided by the responsible person.
• Cosmetic products can only be placed on the market if a natural or legal person resident in Türkiye is appointed as the responsible person.
• The responsible person is the manufacturer for products manufactured in Türkiye and the importer for imported cosmetic products. The distributor is considered to be the responsible person if it places a product on the market under its own brand or makes a meaningful change (excluding translation) to a product already placed on the market.
• The manufacturer and importer can appoint another natural or legal person as the responsible person with a written agreement. In this case, this person shall be criminally liable and the information of this person shall be included in the company title and address that must be indicated on the packaging.
• Responsible persons must take all necessary measures to ensure that the cosmetic product to be placed on the market is safe. In this regard, in case of a product assessment that does not comply with the legislation, they must immediately take the necessary corrective measures to bring the product into compliance, withdraw it from the market or recall it, and in cases where the cosmetic product poses a risk to human health, they must immediately notify the TİTCK about any action they have taken.
• The responsible person must employ and register a responsible technical person (“RTP”) with the appropriate level of professional competence and the necessary experience in the product tracking system. The company must continue to employ an RTP throughout the duration of its cosmetic product activities.
• Chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists can be designated as STEs.
• A Product Information File (“PIF”) must be kept at an address in Türkiye specified on the label of the cosmetic product. The PIF must contain information on the cosmetic product, its characteristics, and the Product Safety Assessment Report.
• Cosmetic product safety assessment should be carried out by a person who has a diploma or other official proof of competence showing that they have completed a theoretical and practical university education in pharmacy, toxicology, medicine or a similar discipline or another education program whose equivalence is accepted by the TİTCK. Persons with diplomas in pharmacy, toxicology and medicine must attach their diploma samples; other professional groups must attach documents proving that they are competent to prepare a product safety assessment report to the end of this report.

The Guideline is available here (in Turkish).

Decree on the Pricing of Pharmaceuticals

The TİTCK published the Decree Amending the Decree on the Pricing of Pharmaceuticals. The main amendments introduced by the Decree are as follows:

• The following warehouse profit rates will apply when determining the retail prices of products other than pharmaceuticals:
• 8% for amounts up to TRY 100 (including TRY 100)
• 6% for amounts between TRY 100-200 (including TRY 200)
• 3% for amounts above TRY 200
• The value of EUR 1 in TRY to be used in the pricing of pharmaceuticals was increased by 25% to TRY 17.5483.
• The thresholds have been set at TRY 60.51 for the price-protected products and TRY 31.62 for other products in proportion to the change in the value of EUR.
• When applying the increase, except for non-refundable products, the remaining increases of up to TRY 4 for products in the Detailed Drug Price List with a Sale Price to Warehouse above TRY 55.90 (including TRY 55.9 0) will be exempt from offsetting during the EUR value update. A periodic EUR value update will be made excluding the remaining increases. In this context, the selling prices of the products to the warehouse will be added to the selling prices of the products without any change in the TRY value.
• To ensure sustainable health service delivery, the Price Valuation Commission will be able to take ex officio decisions upon the invitation of the TİTCK in case of supply problems that affect or are foreseen to affect the normal life activities of the whole or certain segments of society.

The Decree is available here (in Turkish), and our legal alert on the pricing of pharmaceuticals is available here for details.

Regulation on the Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices

On 20 December 2023, the TİTCK published the Regulation Amending the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices. The main amendments introduced by the Regulation are as follows:

• The obligation of health service providers to have the quality control tests of devices performed by medical physicists and quality conformity tests performed by quality conformity organizations may be temporarily suspended by the TİTCK as needed, and the devices for which the obligation is suspended will be announced by the TİTCK.
• In case the obligation is temporary suspended, the quality control and quality conformity procedures for these devices will be carried out in accordance with national and international protocols, guidelines and standards, and manufacturer criteria.
• Quality conformity bodies shall not provide services to those who are not included in the authorization certificate of devices that are obliged to have quality conformity tests performed by the quality conformity body.
• The authorization certificate of the quality conformity body, which is found to have performed quality conformity tests on the devices that are obliged to have quality conformity tests performed by the quality conformity body, outside the scope of the authorization certificate or while the authorization certificate is suspended, and the work certificates of the persons working within its body, will be canceled.
• Medical physicists shall not provide services for devices that are not included in the work certificate of devices that are obliged to have quality conformity and quality control tests performed by a medical physicist.
• The working certificate of the medical physicist who is found to have performed quality control tests on devices that are obliged to have quality control tests performed by a medical physicist, and quality conformity tests on devices that are obliged to have quality conformity tests performed by a quality conformity body, while outside the scope of the working certificate or while the working certificate is suspended, will be canceled.

The Regulation is available here (in Turkish).

Regulation on Variations in Pharmaceuticals with Marketing Authorization

On 26 December 2023, the TİTCK published the Regulation Amending the Regulation on Variations in Pharmaceuticals with Marketing Authorization. The main amendments introduced by the Regulation are as follows:

• If the variations submitted to the TİTCK with a request to change the place of pharmaceutical production from Türkiye to abroad (or vice versa) are approved, a new marketing authorization shall be issued for the pharmaceutical in question.
• In cases where it is requested to cancel the existing marketing authorization for the pharmaceutical for which a diversification application is submitted, the marketing authorization process must be initiated upon formal notification to the applicant of the acceptance of the preliminary evaluation of the marketing authorization application.
• In cases where the existing marketing authorization for the pharmaceutical for which a diversification application is made is canceled and a new authorization is issued, products with barcodes belonging to the old marketing authorization will be allowed to be produced and placed on the market with the same barcode for a period of 6 months from the date of issuance of the marketing authorization. The control procedures regarding the production notifications of the products in this situation shall be carried out through the Pharmaceutical Tracking System, and these products can be placed on the market until their expiry date.

The Regulation is available here (in Turkish).

Regulation on the Marketing Authorization of Pharmaceuticals

On 26 December 2023, the TİTCK published the Regulation Amending the Regulation on the Marketing Authorization of Pharmaceuticals. The main amendments introduced by the Regulation are as follows:

• Real persons or legal entities must also submit to the TİTCK a joint marketing agreement containing the written consent of real persons or legal entities for joint marketing and the trade registry certificate of the parties in the marketing authorization application, if the pharmaceutical manufactured or to be manufactured in Türkiye is subject to joint marketing.
• If the information and documents requested by the TİTCK other than the preliminary evaluation process or the information and documents requested by the TİTCK or the date of submission and the necessary explanation for the failure to submit such information and documents are not submitted to the TİTCK within 30 days at the latest, the marketing authorization application shall be rejected on the merits.
• If it is detected that the specified fees and charges related to a pharmaceutical with marketing authorization are not paid, the marketing authorization of the pharmaceutical shall be suspended by the TİTCK according to the result of the evaluation made by the TİTCK regarding the relevant noncompliance.
• The marketing authorization suspension period for products suspended for the following reasons can be extended for up to 30 months if deemed appropriate by the TİTCK:
• Provided that it is approved by the TİTCK, at least one commercial series of a pharmaceutical has not been placed on the market within the first 30 months from the date of granting marketing authorization, except in cases where it is not produced for a single country market or cannot be placed on the Turkish market due to the size of the commercial series,
• Determination that at least one commercial series of a pharmaceutical with marketing authorization manufactured in Türkiye and previously placed on the market within the scope of the QR code application is not available in the domestic or foreign markets for at least 30 months without interruption; or for products imported to Türkiye, it is not available in the domestic market; or for pharmaceuticals outside the scope of QR code application, official documents showing that they have been placed on the market are not submitted to the TİTCK,
• Failure by the marketing authorization holder to place the pharmaceutical, which is important for public health and the sustainability of access to medicines, on the market within 6 months from the date of the request, despite being requested by the TİTCK,
• Failure by the marketing authorization holder to submit the document showing that the production site(s) based on the marketing authorization is/are in compliance with the Good Manufacturing Practice Guidelines and the Production Site Authorization Certificate for the active substance production site(s) operating in Türkiye in the marketing authorization transfer applications.
• For radionuclide generators, kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals placed on the market with a registration certificate and for which a registration application has been made, the registration process must be completed by 31 December 2025. Registration certificates for products that fail to obtain marketing authorization within this period will be invalid.
• The file of the pharmaceutical for which a marketing authorization is applied should not include domestic and foreign production facilities at the same time as the place of production.

The Regulation is available here (in Turkish).

Regulation on Clinical Trials of Pharmaceuticals

On 29 December 2023, the TİTCK published the Regulation Amending the Regulation on Clinical Trials of Pharmaceuticals. The main amendments introduced by the Regulation are as follows:

• Clinical trial applicants must keep the original copies of all documents submitted to the TİTCK and submit them to the TİTCK upon request.
• Phase 1 centers and bioavailability and bioequivalence centers for which a certificate of conformity was issued before 27 May 2023 must apply to the TİTCK to bring their authorization documents into compliance with the Regulation as of 1 January 2024.

The Regulation is available here (in Turkish).

Guideline on Conditions for Exports Except to Pharmacies

On 29 December 2023, the TİTCK published the Guideline on Conditions for Exports Except to Pharmacies. The main amendments introduced by the Guideline are as follows:

• Products shall not be exported outside the country without a valid export permit issued by the TİTCK.
• It is essential to supply all products to be exported from the manufacturer.
• Domestic manufacturers or companies that have pharmaceuticals with marketing authorization in their own name in Türkiye and/or abroad must export their own products through their own companies or companies authorized by them. Companies that are domestic manufacturers or companies authorized by companies that have pharmaceuticals with marketing authorization in Türkiye and/or abroad on their behalf must apply for an export permit only for the authorized products.
• Companies wishing to export products under their own trademarks that they do not have an authorization for but have manufactured domestically must apply for an export permit.
• Companies that will apply for an export permit must have a company registration in the Electronic Application System of the TİTCK. After the company registration, the applicant must apply for the export permit by selecting the application document type “Export Permit for Authorized Company” with a cover letter. As a result of the evaluation made by the TİTCK, “Export Permit for Authorized Company” shall be issued for the approved applications.
• If the company or the responsible manager changes or the responsible manager resigns, the export permit shall be suspended at the end of the specified period.
• Records of all kinds of transactions related to the shipment carried out in companies must be kept in the company in original written or electronic media as a way to ensure traceability. The records and backed up data must be kept for at least 5 years and all documents should be easily accessible in case of need.
• Companies authorized to export must operate under the responsibility of a responsible manager who shall be in charge of the procurement, sale, distribution and export of products, excluding the sale to final consumers, in accordance with the relevant legislation and the principles of good distribution practices.
• In case the position of responsible manager becomes vacant, the authorized company to export must notify the TİTCK within 5 business days at the latest. To appoint a new responsible manager, an application must be made to the TİTCK with the necessary documents within 15 business days at the latest as of the vacancy of this duty. Otherwise, the authorized company’s permit shall be suspended until the new responsible manager is appointed.
• Marketing authorization holder companies and exporting companies shall be jointly and severally responsible for the works and transactions carried out.
• In case of any problem with the products exported by the companies, the health authority of the country of export and the TİTCK must be informed by the authorized company to export.

The Guideline 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 necessary actions to ensure compliance.