Human medicinal products
Guideline amendment on the development and licensing of biosimilar medicinal products. Published by the Turkish Medicines and Medical Devices Agency (“ Agency ” or “ TİTCK ”) on April 21, 2026, this guideline amendment aims to accelerate the development process of biosimilar products and reduce costs by decreasing the number of tests that do not provide additional scientific value. In this context, among other things, the requirement to conduct animal tests and Phase III studies that are deemed not to provide additional safety and efficacy has been removed. Furthermore, exemption from in vivo animal studies may be granted if sufficient structural and functional similarity and comprehensive in vitro data are demonstrated. This exemption requires comparison of a certain number of batches of the biosimilar and the reference product, the existence of a predetermined similarity plan, and verification of production and control processes. The guideline also removes the requirement for "side-by-side" analysis in quality comparisons; it allows for analyses to be performed at different times and results to be evaluated together.
Guidelines for procuring medicines from abroad have been amended. With the guidelines updated on June 5, 2026, it has been stipulated that for medicines declared by the Agency as being directly available to hospitals through foreign pharmaceutical suppliers, further Agency approval will no longer be required. Hospitals can apply directly to foreign pharmaceutical suppliers for these medicines. For products not included in this scope, applications for bulk procurement of medicines from abroad in medical emergencies will continue to be subject to the Agency's evaluation.
Guidelines on the recall of human medicinal products and foods for special medicinal purposes. The Agency amended the Guidelines on the Recall of Human Medicinal Products and Foods for Special Medicinal Purposes on July 21, 2026. Within this scope:
Export notification. In cases where defective product batches are exported, it is now mandatory to attach to the preliminary report a document proving that the license/permit holder in the relevant country has been informed.
Final report. In line with the regulations on the recall of human medicinal products and food products for special medicinal purposes, the license/authorization holder's obligation to submit a final report after ensuring that all defective products on the market have been recalled has been retained; in addition, it is possible to request a one-time extension of four weeks for the submission of the final report.
Guideline amendment regarding variations in licensed human medicinal products. With the guideline amendment published on July 22, 2026, the preliminary assessment period for the Agency to determine whether a "Type IB" minor variation notification should be accepted as a variation has been set at 7 days. The annexes to the guideline also include updated tables regarding changes in the production process and batch size, andthe scope of documents required for PMF ( Plasma Master File ) applications has been clarified.
Guidelines on the naming of medicinal products for human use. Published by the Agency on July 31, 2026 and entering into force on January 1, 2027, these guidelines provide guidance to applicants on the selection of names for medicinal products for human use and define the procedures and principles of the name evaluation process to be conducted by the Agency. In this context:
Unacceptable names. Trade names are regulated to be non-encouraging, and expressions that contain unproven claims of superiority or suggest use outside of approved indications are considered encouraging. Furthermore, trade names must not be derived from INNs (International Nonproprietary Names ) , and 70% or more of the proposed trade name must not consist of INN components.
Evaluation Process. Name evaluation applications will first undergo a preliminary evaluation through the TİTCK Name Suitability and Similarity Analysis System (“ TİBAS ”). Names with a similarity rate of 80% and above will be directly rejected, while those with a similarity rate of 79% and below will be submitted to the Scientific Commission or Board for Evaluation of Human Medicinal Product Name Proposals (“ Commission/Board ”) for evaluation within 30 days. If the proposed name is deemed unsuitable, the applicant will be notified of the reason for rejection, and the applicant will be expected to reapply with up to five new name proposals, ranked according to priority.
Appeal. If the proposed name is not accepted, the applicant may appeal only once within 30 days. Upon appeal, the Commission/Board will re-evaluate the application, requesting additional clarification if necessary.
Validity period. For unlicensed products, the approved name is valid for one year. If a license application is not submitted within this period, a new application for the name must be submitted. In case of procedural or substantive rejection of the license application, the name will remain valid for one year from the date of rejection. For a different company to be able to use the name of a product whose license has been revoked, five years must pass from the date of publication of the revocation on the Authority's website. This period may be extended by the Authority's decision in cases of revocation due to serious security risks.
Transitional provisions. For products for which a licensing application was submitted before the effective date of this guide, there is no need to apply for a naming change; for licensed products, a change of trade name is optional.
Guidelines on sampling procedures and principles have been revised. With the revision made on August 4, 2026, foods for special medicinal purposes have been explicitly included within the scope of these guidelines. Due to the entry into force of a separate guideline regarding recalls, sampling procedures within the scope of recall activities have been excluded from this guideline. However, the active ingredient sampling process has been added as a separate section, and a new record form specific to this process has been introduced.
Guidelines on packaging information and instructions for use of medicinal products for human use have been revised. The revision, effective August 11, 2026, updates the provisions regarding electronic instructions for use. Accordingly, it has been stipulated that the Pharmaceutical Dosage Forms List, an annex to the Guidelines on the Nomenclature of Medicinal Products for Human Use, should be used instead of the European Pharmacopoeia Standard Terms List, which was previously referenced in determining the pharmaceutical form and route of administration of drugs. Regarding electronic instructions for use, electronic instructions for use (e-IPL) are mandatory for all medicinal products for human use except those intended for administration by healthcare professionals, small packages, and products without outer packaging; printed instructions for use are optional. However, all medicinal products for human use must have at least one set of instructions for use, either printed or electronic.
Guideline amendment regarding situations requiring re-licensing of licensed human medicinal products. The revision, which entered into force on August 11, 2026, includes regulations concerning license transfers and changes of manufacturing location. The main changes are as follows:
Transfer of licenses and changes of production location. In applications for license transfers related to products to be manufactured in Turkey, and in applications for variations regarding the change of production location, whether domestically or abroad, if the applicant is not the manufacturer, it is mandatory to submit a notarized copy of the subcontracting agreement signed with the manufacturer.
Releasing products with old barcodes onto the market . In cases of license transfers, if requested, the period allowing the production and marketing of products with old barcodes after the issuance of a new license has been extended from six months to one year.
Trademark and brand rights. In cases where only a portion of products bearing the same name are transferred, the procedures for the transfer or joint use of trademark rights between the transferring and receiving companies have been revised. Accordingly, if the parties agree on the transfer of trademark rights, the transferring company must apply for a name change for the remaining products before the transfer process is completed. If the parties agree on the joint use of trademark rights, both companies may use the same trademark, provided they submit a trademark registration certificate, a notarized trademark license agreement, and a letter of consent. However, the transfer will not be carried out if the applicant already possesses another licensed product with the same efficacy, pharmaceutical form, and indication as the product subject to the transfer request.
Medical devices
Announcement No. 2026/KKB-1 regarding the mandatory use of the European Medical Devices Database (EUDAMED) data system and its impact on product tracking system document and device registration processes. Inits announcement dated May 4, 2026, the Authority clarified the impact of the mandatory use of the European Medical Devices Database (“ EUDAMED ”) on the Product Tracking System (“ PTS ”) registration processes in Turkey. In parallel with the EU Regulation on EUDAMED, the necessary amendments were made to the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation on August 17, 2024, ensuring the integration of EUDAMED into Turkish legislation. The announcement stated that the EUDAMED usage obligation will not affect existing PTS registration processes, that companies will continue to have document and device registration obligations in the PTS, and that PTS data will prevail in case of data discrepancies.
Guidelines for the registration processes of medical devices in the Product Tracking System. This guideline, which entered into force on May 13, 2026, supersedes the Guidelines on Registration of Medical Devices in the Product Tracking System published on November 15, 2022. The new guideline comprehensively updates the registration processes. In this context, company registration processes, document registration and updating procedures, and mass notification processes have been reorganized; and the application processes for the Product Tracking System related to transitional provisions under EU regulations have also been included in the guideline.
Regulation on the sale, advertising, and promotion of medical devices. With the amendment that came into effect on July 3, 2026, new restrictions have been introduced regarding the online sale of contact lenses. More detailed information on these amendments can be accessed in the announcement we published on July 6, 2026: Innovations concerning plant-based medicinal products, foods for special medical purposes, and medical devices.
Communiqué on specific common quality management and procedural requirements for conformity assessment activities carried out by notified bodies appointed under the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. Published by the Authority on September 16, 2026, this communiqué, in line with Commission Implementing Regulation (EU) 2026/977, regulates the common quality management and procedural requirements for conformity assessment activities of notified bodies. The communiqué regulates the conditions and content of price offers, maximum timeframes for conformity assessment activities (30 days for application review, 120 days for quality management system audit, 90 days for product verification, and 20 days for certification decision), the procedure for suspending timeframes, the annual reporting obligation for monitoring timeframes and costs, and recertification procedures. The provisions regarding annual reporting will enter into force on January 1, 2028, and the other provisions on February 25, 2027.
Healthcare services
Guidelines on import applications for human-derived tissues and cells and products derived therefrom . With the amendment to the guidelines published on April 15, 2026, the procedures and principles regarding import applications have been updated. In this context, among other things, (i) the condition that each application must contain a maximum of 100 items derived from a maximum of 10 donors and that the expiration dates of the products must be longer than 1 year from the application date has been added; (ii) the application processes for the import of human tissues and cells and products derived therefrom have been separated and new document and declaration obligations have been introduced; (iii) the submission of an Overseas Conformity Undertaking has been made mandatory for sources located outside of ICH (International Council for Harmonisation) founding or permanent member countries, as well as the UK and Australia.
Herbal and supplement products
Regulation on Aromatherapeutic Products. The regulation, dated July 2, 2026, establishes the procedures and principles for licensing aromatherapeutic products consisting of essential oils, carrier oils, hydrosols, and mixtures thereof, standardized according to pharmacopoeias and monographs. More detailed information regarding the regulation can be accessed in the announcement we published on July 6, 2026: Innovations in plant-based medicinal products, foods for special medicinal purposes, and medical devices.
Regulation on medicinal herbal teas. Under the regulation dated July 2, 2026, a specific regulation for medicinal herbal teas has been introduced, separate from the general food and supplement legislation; within this scope, the placing of these products on the market is subject to licensing by the Authority, and the procedures and principles regarding licensing have been determined. More detailed information regarding the regulation can be accessed from the announcement text we published on July 6, 2026: Innovations regarding herbal-based medicinal products, foods for special medicinal purposes, and medical devices.
Regulation on amendments to the licensing regulation for traditional herbal medicinal products. With the amendment dated July 2, 2026, a shortened application procedure based on evidence of "well-known use" and monographs from the Agency or the EMA ( European Medicines Agency ) has been introduced, a separate application type has been foreseen for endemic plants, and the licensing renewal application period has been shortened. More detailed information on the changes can be accessed in the announcement text we published on July 6, 2026: Innovations concerning herbal-based medicinal products, foods for special medicinal purposes, and medical devices.
Regulation amendment on licensing of foods for special medicinal purposes. Within the scope of the Regulation Amending the Regulation on Licensing of Foods for Special Medicinal Purposes dated July 2, 2026, amendments have been made regarding the re-determination of pesticide residue limits on an individual basis for products intended for infants and young children, granting the Authority to establish a scientific advisory committee, and extending the licensing application period for products currently on the market with existing permits to July 1, 2027. More detailed information regarding the amendments can be accessed from the announcement text we published on July 6, 2026: Innovations regarding plant-based medicinal products, foods for special medicinal purposes, and medical devices.
Clinical trial
Guideline amendment for Good Clinical Practice (GCP) audits. With the guideline amendment that came into effect on July 24, 2026, the application procedures and forms to be used for applications to the Agency within the scope of Good Clinical Practice have been updated. In this context, the requirement for centers to be affiliated with the Ministry of Health or a university to conduct Phase 1 and BY/BE ( bioavailability/bioequivalence ) studies has been removed, allowing other health institutions and organizations, as well as research and development centers approved by the Agency, to conduct these studies. Furthermore, it has been stipulated that prior notification may be given for routine audits, while audits based on a specific reason may be conducted without prior notice.
Cosmetic products
Guidelines for the labeling of perfume allergens used in cosmetic products. These guidelines, which entered into force on June 11, 2026, establish the procedures and principles for the labeling of perfume allergens within the scope of Annex III of the Cosmetic Products Regulation. In this context, among other things, (i) it is mandatory to separately list allergens exceeding 0.01% in rinse-off products and 0.001% in leave-in products; (ii) the principle of using the INCI (International Nomenclature of Cosmetic Ingredients) name from the common ingredients dictionary in labeling has been adopted; and (iii) a grouped allergen category has been provided for substances carrying a risk of cross-allergy, requiring these allergens to be identified by their group name on the label.
Guidelines regarding the duties, authorities, and responsibilities of the Responsible Technical Personnel (RTP). These guidelines, which came into effect on July 2, 2026,define the qualifications, duties, authorities, responsibilities, and working procedures of the Responsible Technical Personnel ("RTP") that must be employed by cosmetic companies. In this context, among other things, (i) a limited number of professional groups (chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists, and pharmacists) that can be assigned as RTPs have been determined; (ii) the registration of RTPs via e-signature through the Turkish Medical Devices Database (TMT) has been made mandatory; (iii) an RTP can work with a maximum of 10 companies in their place of residence and a maximum of 5 companies in different locations; and (iv) all active cosmetic companies, whether they have already launched products on the market or not, are required to employ RTPs. Existing RTP and responsible person contracts must be brought into compliance with these guidelines by October 2, 2026 at the latest.