Recent developments in healthcare legislation - Issue 2026/2

Medicinal products for human use

Amendment to the guideline on the development and licensing of biosimilar medicinal products. On 21 April 2026, the Turkish Medicines and Medical Devices Agency (the “Agency”) published amendments to the guideline with a view to streamlining the biosimilar development process and reducing costs by eliminating tests that do not provide additional scientific value. In this context, among others, the requirement to conduct animal tests that were deemed not to generate additional safety or efficacy, as well as Phase III studies, were removed. In addition, applicants may be exempted from in vivo animal studies where they can demonstrate sufficient structural and functional similarity, supported by comprehensive in vitro data. Such an exemption requires a comparison of a specified number of batches of the biosimilar and the reference product, a pre-defined similarity plan, and validated manufacturing and control processes. The amendments also removed the requirement for quality comparisons to be performed on a “side-by-side” basis thereby allowing analyses to be carried out at different times, with their results assessed together.

Amendment to the guideline on the procurement of medicines from abroad. Under the guideline updated on 5 June 2026, for medicines announced by the Agency as being directly procurable by hospitals through foreign medicine suppliers will no longer require separate Agency approval. Hospitals may apply directly to foreign medicine suppliers to procure these medicines. Products falling outside this scope remain subject to the existing regime, where bulk procurement applications from abroad in cases of medical emergency will continue to require Agency’s evaluation.

Guideline on the recall of medicinal products for human use and foods for special medical purposes. The Agency amended the Guideline on the Recall of Medicinal Products for Human Use and Foods for Special Medical Purposes on 21 July 2026. In this context:

• Export notification. Where defective product batches have been exported, a document confirming that the marketing authorisation/permit holder in the relevant country has been notified must be included in the preliminary report.
• Final report. In line with the provisions of the Regulation on the Recall of Medicinal Products for Human Use and Foods for Special Medical Purposes, the obligation of the marketing authorisation/permit holder to submit a final report after ensuring that all defective products on the market have been recalled has been maintained. In addition, a one-off extension of four-weeks for the submission of the final report may now be requested.

Amendment to the guideline on variations to licensed medicinal products for human use. The guideline amendment published on 22 July 2026 introduces a 7-day deadline for the Agency to complete its preliminary assessment of whether a “Type IB” minor variation notification qualifies as a variation. The annexes have also been updated: the tables on changes to manufacturing processes and batch sizes have been revised, and the documentation requirements for PMF (Plasma Master File) applications have been clarified.

Guideline on the naming of medicinal products for human use. The guideline published by the Agency on 31 July 2026 and entering into force on 1 January 2027 provides guidance to applicants on selecting names for medicinal products for human use and establishes the procedures and principles governing the name evaluation process to be conducted by the Agency. In this context:

• Unacceptable names. It has been stipulated that trade names may not be promotional in nature. Among others, expressions containing unsubstantiated superiority claims or suggesting use beyond the approved indications have been deemed promotional. In addition, trade names may not be derived from the INN (International Nonproprietary Name), and no more than 70% of the proposed trade name may consist of INN components.
• Evaluation process. Name evaluation applications will first be subject to a preliminary assessment through the Agency’s Name Suitability and Similarity Analysis System (“TIBAS”). Names with a similarity rate of 80% or above will be directly rejected, while those with a rate of 79% or below will be referred to the Scientific Commission or Board for the Evaluation of Medicinal Product Name Proposals (the “Commission/Board”) for evaluation within 30 days. If the proposed name is found unsuitable, the applicant will be notified of the grounds for rejection and will be expected to re-apply with up to five new name proposals listed in order of priority.
• Objection. If the proposed name is not accepted, the applicant may file an objection only once within 30 days. The Commission/Board will then re-evaluate the application, requesting further clarification where necessary.
• Validity period. An approved name for an unlicensed product will remain valid for one year, and if a marketing authorisation application is not filed within that period, a new name application must be submitted. Where a marketing authorisation application is rejected on procedural or substantive grounds, the approved name will remain valid for one year from the date of rejection. For a product whose marketing authorisation has been revoked, the same name may only be used by another company once five years have elapsed from the date the revocation is published on the Agency’s website; this period may be extended by the Agency where the revocation is linked to serious safety risks.
• Transitional provisions. Products for which a marketing authorisation application has been submitted prior to the guideline’s effective date are not required to file a naming application. For products that already hold a marketing authorisation, a trade name change remains optional.

Amendment to the guideline on sampling procedures and principles. The revision dated 4 August 2026 expressly introduces foods for special medical purposes within the scope of the guideline. As a separate guideline on recall activities has been entered into force, sampling provisions relating to recall activities have been excluded from this guideline. Additionally, the active substance sampling process has been added as an independent section, and a new protocol form specific to this process has been introduced.

Amendment to the guideline on packaging information and patient information leaflets for medicinal products for human use. The amendment that entered into force on 11 August 2026 updates the provisions concerning electronic patient information leaflets (“e-PILs“). In this regard, it has been stipulated that the List of Pharmaceutical Dosage Forms annexed to the Guideline on the Naming of Medicinal Products for Human Use must be taken as the basis for determining the pharmaceutical form and route of administration of medicinal products, replacing the previously referenced European Pharmacopoeia Standard Terms List. As regards e-PILs, they have been made mandatory for all medicinal products for human use, with the exception of products intended to be administered solely by healthcare professionals, products falling within the small packaging category and products without outer packaging. Printed patient information leaflets have been rendered optional. That said, all medicinal products for human use are required to include at least one patient information leaflet, whether printed or electronic.

Amendment to the guideline on circumstances requiring re-issuance of marketing authorisations for licensed medicinal products for human use. The revision that entered into force on 11 August 2026 introduces provisions on marketing authorisation transfers and changes to manufacturing sites. The key amendments are as follows:

• Transfer and manufacturing site changes. For marketing authorisation transfer applications relating to products to be manufactured in Türkiye, as well as for variation applications concerning changes to the manufacturing site whether within or outside of Türkiye, where the applicant is not the manufacturer, the submission of a notarised contract manufacturing agreement concluded with the manufacturer has been made mandatory.
• Marketing of products with old barcodes. In marketing authorisation transfers, upon request, the period during which the manufacture and marketing of products bearing old barcodes is permitted following the issuance of a new marketing authorisation has been extended from six months to one year.
• Trade name and trademark rights. Where only some of the products bearing the same name are being transferred, the procedures governing the transfer or joint use of trademark rights between the transferor and the transferee have been revised. Accordingly, where the parties agree on the transfer of the trademark right, the transferor must submit a name change application for the products it retains before the transfer process is completed. Where the parties agree on joint use of the trademark, both companies may use the same trademark, provided that a trademark registration certificate, a notarised trademark licence agreement and a letter of consent are submitted. However, the transfer will not be carried out where the applicant holds a marketing authorisation for another product with the same strength, pharmaceutical form and indication with the product that is the subject of the transfer request.

Medical devices

Announcement No. 2026/KKB-1 on the mandatory use of The European Database on Medical Devices data system and its impact on product tracking system document and device registration processes. In its announcement dated 4 May 2026, the Agency provided clarifications regarding the impact of the mandatory use of the European Database on Medical Devices (“EUDAMED”) on Product Tracking System (Ürün Takip Sistemi, “ÜTS”) registration processes in Türkiye. In line with the EU Regulation on EUDAMED, the necessary amendments were previously introduced to the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation on 17 August 2024, thereby integrating EUDAMED into the Turkish legislation. The announcement confirmed that the EUDAMED obligation will not affect the existing ÜTS registration processes, that companies will continue to be subject to their ÜTS document and device registration obligations, and that ÜTS data will prevail in the event of any data discrepancy.

Guideline on the registration processes of medical devices in the product tracking system. The guideline, which entered into force on 13 May 2026, abolished the Guideline on the Registration of Medical Devices in the Product Tracking System dated 15 November 2022. Under the new guideline, ÜTS registration processes have been comprehensively updated. In this context, company registration processes, document registration and update procedures, and bulk notification processes have been revised, and ÜTS application processes relating to the transitional provisions under the EU regulations have also been incorporated into the guideline.

Regulation on sales, advertisement and promotion of medical devices. The amendment that entered into force on 3 July 2026 introduces new restrictions on the online sale of contact lenses. Further information regarding the amendments can be found in the announcement we published on 6 July 2026: Legal developments regarding herbal medicinal products, foods for special medical purposes and medical devices

Communiqué on certain common quality management and procedural requirements for conformity assessment activities carried out by notified bodies designated under the medical device regulation and the in vitro diagnostic medical device regulation. Published by the Agency on 16 September 2026, this communiqué sets forth common quality management and procedural requirements applicable to the conformity assessment activities of notified bodies in line with the EU Commission’s Implementing Regulation 2026/977. The communiqué provides for the terms and content of price quotations, sets maximum timeframes for conformity assessment activities (30 days for application review, 120 days for quality management system audits, 90 days for product verification and 20 days for the certification decision), establishes rules on the suspension of those timeframes, introduces annual reporting obligations for monitoring timeframes and costs, and sets out re-certification procedures. The annual reporting provisions will enter into force on 1 January 2028, while the remaining provisions will enter into force on 25 February 2027.

Healthcare services

Guideline on import applications for human-derived tissues and cells and products obtained therefrom. The guideline amendment published on 15 April 2026 updates the procedures and principles governing import applications. In this context, among others, (i) a condition has been introduced requiring that each application is now limited to a maximum of 100 items of products obtained from no more than 10 donors, and that the products’ expiry dates must extend beyond one year from the date of application, (ii) the application processes for the import of human tissues and cells and the products derived therefrom have been separated and new documentation and declaration requirements have been introduced, and (iii) the submission of a Foreign Conformity Undertaking has been made mandatory for sources located outside the ICH (International Council for Harmonisation) founding or standing member countries, the United Kingdom and Australia.

Herbal and support products

Regulation on aromatherapeutic products. The regulation dated 2 July 2026 establishes the procedures and principles governing the licensing of aromatherapeutic products consisting of essential oils standardised in accordance with pharmacopoeias and monographs, carrier oils, hydrosols and their mixtures. More detailed information regarding the regulation can be accessed from our announcement published on 6 July 2026: Legal developments regarding herbal medicinal products, foods for special medical purposes and medical devices

Regulation on medicinal herbal teas. The regulation dated 2 July 2026 establishes a standalone regime for medicinal herbal teas, separate from the food supplement and general food legislation. Accordingly, the placing of such products on the market has been made subject to licensing by the Agency, and the relevant procedures and principles have been set out. More detailed information regarding the regulation can be accessed from our announcement published on 6 July 2026: Legal developments regarding herbal medicinal products, foods for special medical purposes and medical devices

Regulation on amendments to the regulation on licensing of traditional herbal medicinal products. The regulation amendment dated 2 July 2026 introduces an abridged application procedure based on “well-established use” evidence and monographs published by the Agency or the EMA (European Medicines Agency), establishes a separate application type for endemic plants, and shortens the licence renewal application period. More detailed information regarding the amendments can be accessed from our announcement published on 6 July 2026: Legal developments regarding herbal medicinal products, foods for special medical purposes and medical devices

Amendment to the regulation on licensing of foods for special medical purposes. The Regulation on Amendments to the Regulation on Licensing of Foods for Special Medical Purposes dated 2 July 2026 introduces amendments concerning the redetermination of pesticide residue limits on an individual basis in products intended for infants and young children, the granting of authority to the Agency to establish a scientific advisory committee, and the extension of the deadline for marketing authorisation applications for products currently on the market under existing permits to 1 July 2027. More detailed information regarding the amendments can be accessed from our announcement published on 6 July 2026: Legal developments regarding herbal medicinal products, foods for special medical purposes and medical devices

Clinical research

Amendment to the guideline on applications for good clinical practice inspections. The guideline amendment that entered into force on 24 July 2026 updates the application procedures and forms to be used in good clinical practices applications to the Agency. In this context, the requirement for centres conducting Phase 1 and BA/BE (bioavailability/bioequivalence) studies to be affiliated with the Ministry of Health or a university has been removed, thereby enabling other Agency-approved healthcare institutions and facilities, as well as research and development centres, to conduct such studies. Furthermore, it has been stipulated that an advance notice may be given for routine inspections, while cause-based inspections may be carried out without prior notice.

Cosmetic products

Guideline on the labelling of perfume allergens used in cosmetic products. The guideline, which entered into force on 11 June 2026, sets out the labelling requirements for perfume allergens listed in Annex III of the Cosmetic Products Regulation. In this context, among others, (i) allergens present above 0.01% in rinse-off products and above 0.001% in leave-on products must now be separately identified in the ingredients list; (ii) INCI (International Nomenclature of Cosmetic Ingredients) names drawn from the common ingredients glossary must be used as the labelling standard; and (iii) a grouped allergen category has been introduced for substances that carry a cross-allergenicity risk, requiring them to be identified on the label by their group name.

Guideline on the duties, powers and responsibilities of the responsible technical person. The guideline, which entered into force on 2 July 2026, lays down the qualifications, duties, powers, responsibilities and working procedures of the responsible technical person (“RTP”) that cosmetic companies are required to employ. In this context, among others, (i) the professional groups eligible for appointment as an RTP have been exhaustively defined (limited to chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists); (ii) RTP registration must now be mandatorily completed via e-signature through the ÜTS; (iii) an RTP may serve a maximum of 10 companies in their place of residence and up to 5 companies in other locations; and (iv) all active cosmetic companies are required to employ an RTP, regardless of whether they have placed products on the market. Existing RTP and responsible person agreements must be brought into compliance with the guideline by 2 October 2026 at the latest.