Healthcare & Life Sciences Newsletter - January 2025

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently amended i) the Regulation on the Marketing Authorization of Pharmaceuticals, ii) the Regulation on the Marketing Authorization of Conventional Herbal Pharmaceuticals, iii) the Regulation on the Marketing Authorization of Homeopathic Pharmaceuticals, and iv) the Guideline on Packaging Information and Instructions for Use of Pharmaceuticals.

Regulation on the Marketing Authorization of Pharmaceuticals, Regulation on the Marketing Authorization of Conventional Herbal Pharmaceuticals, Regulation on the Marketing Authorization of Homeopathic Pharmaceuticals

On 3 December 2024, the TİTCK published i) the Regulation Amending the Regulation on the Marketing Authorization of Pharmaceuticals, ii) the Regulation Amending the Regulation on the Marketing Authorization of Conventional Herbal Pharmaceuticals, and iii) the Regulation Amending the Regulation on the Marketing Authorization of Homeopathic Pharmaceuticals.

The amendments introduced by the aforementioned regulations have significant resemblances. In this regard, the main amendments introduced to all three regulations are outlined below, followed by the main amendments introduced for each regulation separately.

The main amendments that the regulations have in common are as follows:

– In cases where re-application is made following the rejection of the application for marketing authorization on procedural grounds due to the failure to submit information and documents requested by the TİTCK, the file will be rejected again if it is decided that the changes approved and requested by the TİTCK are not included in the current file, despite the current file including the changes approved or requested by the TİTCK, and the guarantee that the changes have been included, being attached to the application file during re-application, and the decisions on priority in the licensing or audit processes made by the Priority Assessment Board (tr. Öncelik Değerlendirme Kurulu) for the relevant product will be canceled.

– In the event of serious supply problems that will adversely affect the ordinary life and activities of the whole or certain segments of society, the TİTCK may, upon the request of a marketing authorization holder to ensure the sustainability of healthcare services by the Ministry of Health, allow the placing of an authorized pharmaceutical on the market in limited quantities for a limited period of time, provided that it is limited to individual cases, the circumstances do not prejudice the safety of the product, and the Priority Assessment Board deems it acceptable.

– In the event of a marketing authorization transfer, the joint marketing agreement, including the written consent of the real persons or commercial companies to engage in joint marketing and the trade registry certificates of the parties, must be submitted to the TİTCK.

– During the efficacy, quality and safety assessment process of an application submitted to the TİTCK for marketing authorization of a pharmaceutical, the applicant will be entitled to a maximum of 5 written responses. If the product is found to be non-compliant at the end of the assessment process, the marketing authorization application will be rejected. ­

Main amendments to the Regulation on the Marketing Authorization of Pharmaceuticals:

– If the active substance in the composition of the products is supplied domestically, the signed supply agreement and invoice between the active substance supplier and the marketing authorization applicant, and if it is supplied from abroad, the letter of conformity issued by the TİTCK must be submitted in the marketing authorization application.

– If a pharmaceutical for which a variation application is made within the scope of the Regulation on Variations to Pharmaceuticals with Marketing Authorization includes an integrated medical device, CE certificate or notified body opinion will not be required for the integrated medical device of the pharmaceutical for which a variation application is made if the applicant declares that there is no change/addition/subtraction in the integrated medical device of the currently authorized pharmaceutical or a change that will affect the performance of the device.

– As of 1 March 2024, the marketing authorization processes of pharmaceuticals that are currently in the marketing authorization process and for which the analysis results are not found to be compliant will not be conducted until the analysis is found to be compliant.

– For products that are transferred from the conventional herbal pharmaceutical class to the pharmaceutical class, the marketing authorization application must be made within 1 year from the date of the official notification of the transition decision to the applicant and the marketing authorization application must be completed within 5 years. The conventional herbal pharmaceutical marketing authorizations of products that do not apply for and obtain a marketing authorization within the relevant period will be invalid.

– Marketing authorization cannot be transferred as of 1 July 2025 for pharmaceuticals for which marketing authorization has not be renewed.

Main amendments to the Regulation on the Marketing Authorization of Conventional Herbal Pharmaceuticals:

– In cases where the required documents cannot be submitted for the intermediate product manufacturing site(s) used in the manufacturing process of the active substance in the marketing authorization application of traditional conventional herbal pharmaceuticals, i) a declaration that manufacturing is carried out in accordance with good manufacturing practices issued by the active substance manufacturer based on the audit, and ii) an audit report will be required if requested by the TİTCK.

– If the active substance in the composition of the products is supplied domestically, the signed supply agreement and invoice between the active substance supplier and the marketing authorization applicant, and if it is supplied from abroad, the letter of conformity issued by the TİTCK, must be submitted in the marketing authorization application.

– The renewal of the marketing authorization will be assessed by the TİTCK 5 years after the date of issuance. The marketing authorization holder must submit a dossier including all current information on efficacy, safety and quality, including the assessment of suspected adverse reaction reports and periodic benefit/risk assessment reports, and information on all variations of the product made since its marketing authorization to the TİTCK 9 months before the expiration of the 5-year period.

– In marketing authorization transfer applications, the marketing authorization will be suspended if the marketing authorization holder fails to submit i) a document certifying that the manufacturing sites based on the marketing authorization are in compliance with the Good Manufacturing Practice Guidelines and ii) a Manufacturing Site Authorization Certificate for active substance production sites operating in Türkiye.

– Marketing authorization cannot be transferred as of 1 July 2025 for pharmaceuticals for which marketing authorization has not be renewed.

– The TİTCK may request an application for updates and correction of deficiencies in the event that the transfer of the marketing authorization of a conventional herbal pharmaceutical is made through a notary, if deemed necessary.

– As of 21 February 2024, marketing authorization for a pharmaceutical for which the marketing authorization process is ongoing and for which the analysis is not found to be compliant will not be issued until the analysis is found to be compliant.

– An approved organization opinion or CE certificate must be submitted for conventional herbal pharmaceuticals containing an integrated medical device for which a marketing authorization is applied for or which holds a marketing authorization.

Main amendments to the Regulation on the Marketing Authorization of Homeopathic Pharmaceuticals:

– A second marketing authorization will not be issued to the same real person or commercial company for the homeopathic pharmaceuticals authorized by the TİTCK and the product in the same pharmaceutical form with composition and potency at unit dose in terms of homeopathic stock, even though it is under a different trade name. However, applications for homeopathic pharmaceuticals that are scientifically and technologically proven to be advantageous over an authorized homeopathic pharmaceutical or that have grounds deemed to be appropriate by the TİTCK will be evaluated separately.

– An approved organization opinion or CE certificate must be submitted for homeopathic pharmaceuticals containing an integrated medical device for which a marketing authorization is applied for or which holds a marketing authorization.

The Regulation Amending the Regulation on the Marketing Authorization of Pharmaceuticals is available here (in Turkish), the Regulation Amending the Regulation on the Marketing Authorization of Conventional Herbal Pharmaceuticals is available here (in Turkish), and the Regulation Amending the Regulation on the Marketing Authorization of Homeopathic Pharmaceuticals is available here (in Turkish).

Guideline on Legibility of Packaging Information and Instructions for Use of Pharmaceuticals

On 6 December 2024, the TİTCK updated the Guideline on Packaging Information and Instructions for Use of Pharmaceuticals. The main amendments introduced by the Guideline are as follows:

– All pharmaceuticals, except for products intended to be exclusively used by healthcare professionals, must contain electronic instructions for use (“e-KT”) and printed instructions for use on the packaging.

– The e-KT will be accessible via the QR code on the outer packaging. The QR code may be included in a multimedia QR code consisting of multimedia files, or it may be created as an independent QR code.

– The information included in the e-KT must be in line with the current instructions for use and in cases where the instructions for use need to be updated, the e-KT will also be updated within 30 days after the approval of the updated instructions for use.

– The QR code to be placed on the packaging will be in a size and position that will not prevent the readability of other product information.

– The QR code symbol will be displayed along with the phrase “Scan the code for information media.”

– For products with a QR code on the outer packaging, the instructions for use will include the phrase “You can access detailed and up-to-date information about this pharmaceutical by scanning the QR code with a smartphone/tablet or a QR code reader.”

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 the necessary actions to ensure compliance.