The legislative framework for medicinal products, medical devices, food, and food supplements in Türkiye is primarily divided between the Ministry of Health and the Ministry of Agriculture and Forestry.

Medicinal Products: Medicinal products, including biologicals and biosimilars, are governed by the Turkish Medicines and Medical Devices Agency (TMMDA) under the Ministry of Health, primarily following the Law on Pharmaceuticals and Medicinal Preparations (Law No. 1262). Subjects such as licensing/variations, pharmacovigilance, promotion, pricing, and reimbursement are regulated in detail in secondary legislation. Every medicinal product must obtain a marketing authorization from TMMDA, and biological products are subject to additional specialized guidelines concerning clinical data and immunogenicity.

Medical Devices: Matters relating to medical devices are primarily governed by the Regulation on Medical Devices and the Regulation on Medical Devices for In Vitro Diagnostic Purposes. Türkiye has largely harmonized its legislation with European Union standards, adopting the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).

Food and food supplements: Food and food supplements fall under the jurisdiction of the Ministry of Agriculture and Forestry, governed by the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996) and the Turkish Food Codex. While general food products must comply with safety and labeling standards, food supplements require a specific “approval” rather than a medicinal product-style license before they can be manufactured or imported. A significant recent regulatory shift occurred in 2023, where the authority to oversee and permit health claims on food and supplements was transferred to TMMDA.

In Türkiye, the reimbursement processes for medicinal products and medical devices are primarily conducted by the Social Security Institution (SSI) within the framework of the provisions of the Communiqué on Health Implementation (CHI) (Sağlık Uygulama Tebliği – SUT). For a medicinal or biological product to be obtained from pharmacies or hospitals under insurance coverage, it must be included in the reimbursement lists, which are established by relevant commissions after analyzing cost-effectiveness and budgetary impact. Similarly, the reimbursement of medical devices is carried out through the CHI, via specific codes assigned to the devices and the ceiling prices determined for these codes. As a rule, food supplements are not covered by reimbursement. However, “foods for special medical purposes” produced for conditions such as rare metabolic diseases or celiac disease may exceptionally be included in the scope of reimbursement, subject to specific medical report and prescription requirements. Reimbursed products are covered by the SSI either in full or after deducting a designated contribution fee.

The regulatory process for medicinal products and medical devices in Türkiye is overseen by the Turkish Medicines and Medical Devices Agency (TMMDA). This process is based on strict rules and international standards (EU Legislation, ICH, and ISO), spanning from the initial R&D stage to market entry and post-marketing surveillance.

Medicinal Products: The process begins with R&D and preclinical studies. For a product to be tested on humans, it must comply with the Regulation on Clinical Trials of Medicinal Products for Human Use. Sponsors must obtain simultaneous approval from both a local Ethics Committee and TMMDA. Clinical trials are conducted in accordance with Good Clinical Practices (GCP) and the Declaration of Helsinki. For medical devices, a similar clinical evaluation—and, if necessary, a clinical trial process—is conducted in alignment with the European Union’s Medical Device Regulation (MDR). Once clinical data is gathered, a registration dossier in Common Technical Document (CTD) format is prepared and submitted to TMMDA. The TMMDA evaluates the drug’s quality, safety, and efficacy through administrative review, technical assessment, and laboratory analyses. Production facilities must also hold a valid Good Manufacturing Practice (GMP) certificate. The process is finalized after the reference pricing system and Social Security Institution (SSI) reimbursement procedures are completed.

Medical Devices: For medical devices, Türkiye enforces the Regulation on Medical Devices and the Regulation on Medical Devices for In Vitro Diagnostic Purposes, which are largely harmonized with the EU acquis. Depending on their risk class, manufacturers must establish a Quality Management System and obtain a CE Mark through Notified Bodies and subsequently be registered in the Product Tracking System (ÜTS). Additionally, foreign manufacturers must appoint a local authorized representative in Türkiye responsible for registering the device in the Product Tracking System (ÜTS) and ensuring ongoing regulatory compliance.

The oversight process does not end once the product is on the market. For medicinal products, side effects and adverse reactions are monitored through the Turkish Pharmacovigilance Center (TÜFAM). Marketing authorization holders are required to submit Periodic Benefit-Risk Evaluation Reports and implement Risk Management Plans. For medical devices, adverse events are reported via the Materiovigilance system. One of Türkiye’s strongest regulatory features is the real-time, unit-level tracking of every product—via Pharmaceutical Track and Trace System (İTS) for medicines and ÜTS for devices—using 2D barcodes from production to the end-user.

In Türkiye, the regulatory process for food supplements is based on an “approval” mechanism rather than “licensing” (which is used for medicinal products), and the legislation treats these products under the food category.

The process is governed by the Ministry of Agriculture and Forestry within the framework of the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996). An operator must submit an application through the Food Safety Information System in accordance with the provisions of the Regulation on the Importation, Production, Processing and Supply of the Food Supplements. During this stage, the product’s ingredients are reviewed for compliance with the vitamin and mineral limits set by the Turkish Food Codex Communiqué on Food Supplements and the Ministry’s “List of Restricted Substances.” Products found compliant are issued a “Food Supplement Approval Number,” without which it is legally impossible to produce or import the product. In addition, any facility engaged in the manufacture or importation of food supplements must be registered with the Ministry of Agriculture and Forestry as a food business operator in accordance with general food law requirements.

The packaging and promotion of the product must comply with the Turkish Food Codex Regulation on Food Labeling and Consumer Information. The most critical aspect of food supplements is their advertising and health claims. Following a significant update in 2023, the Regulation on the Use of Health Claims in Food and Food Supplements transferred the authority to regulate and permit all health claims (e.g., “supports the immune system”) to the Turkish Medicines and Medical Devices Agency (TMMDA). This regulation strictly prohibits marketing food products with therapeutic or indication claims.

Once a product is placed on the market, it is subject to continuous inspection under the Regulation on Official Controls of Food and Feed. Inspectors from the Ministry of Agriculture and Forestry take samples from the market to conduct laboratory analyses, ensuring the content matches the approved dossier (formulation) and checking for the presence of unauthorized active ingredients (adulteration). In cases of non-compliance, measures such as product recalls, destruction, cancellation of approval, and heavy administrative fines are applied pursuant to Law No. 5996. Furthermore, advertising and promotional activities that violate the legislation (including online sales) are strictly monitored by both the Ministry of Agriculture and Forestry and the Advertising Board under the Ministry of Commerce, with significant penalties applied for non-compliance.

In Türkiye, obtaining a marketing authorization for a medicinal product or completing the conformity assessment for a medical device to place it on the market entails a comprehensive series of legal obligations that continue throughout the product’s lifecycle.

Medicinal Products: For medicinal products, one of the primary responsibilities of the marketing authorization holder is to establish a continuous pharmacovigilance system. In this context, companies must appoint a qualified person responsible for pharmacovigilance residing in Türkiye, report all suspected adverse reactions to the Turkish Pharmacovigilance Center (TÜFAM), and regularly submit Periodic Benefit-Risk Evaluation Reports to the Turkish Medicines and Medical Devices Agency (TMMDA). Additionally, manufacturing facilities must maintain Good Manufacturing Practice (GMP) standards, any administrative or technical changes (variations) to the product must be submitted for the TMMDA approval, and price updates must be tracked in accordance with the reference pricing system. Besides, the TMMDA has the authority to withdraw products from the market or suspend/cancel the license if it detects a disruption in the benefit/risk balance, insufficient therapeutic effect, quality defects, safety issues, or the failure to supply products for a specified period of time.

Medical Devices: Regarding medical devices, the obligations are focused on Post-Market Surveillance (PMS) and Materiovigilance, in alignment with the European Union’s Medical Device and IVD Regulations (MDR/IVDR). Manufacturers or importers are required to actively monitor the performance and safety of the device while it is on the market, report adverse events, and carry out Field Safety Corrective Actions (FSCA) when necessary. For high-risk devices, it is mandatory to prepare Periodic Safety Update Reports (PSUR) at specific intervals and continue Post-Market Clinical Follow-up (PMCF) activities to ensure clinical data remains up to date. Furthermore, every organization must employ at least one person responsible for regulatory compliance and all product movements must be reported in real-time via the Product Tracking System (ÜTS).

Another critical common obligation for both medicinal products and medical devices is the restriction on promotion and advertising. In Türkiye, advertising prescription-only medicines to the general public is strictly prohibited; only scientific promotion directed at healthcare professionals is permitted within the framework of the Regulation on Promotional Activities of Medicinal Products for Human Use. For medical devices, similar restrictions apply based on the risk class and intended use of the product, ensuring that misleading claims are avoided and advertisements do not jeopardize public health, being restricted to specific platforms and advertisements are limited to appropriate professional channels.

Medicinal Products and Medical Devices: The TMMDA, an administratively autonomous body under the Ministry of Health, is the sole competent authority for medicinal products and medical devices. Its responsibilities include the marketing authorization of drugs, approval and inspection of clinical trials, issuance of Good Manufacturing Practice (GMP) certificates to production facilities, and monitoring product safety through pharmacovigilance and materiovigilance systems. The TMMDA also manages the Product Tracking System (ÜTS) registrations required for medical devices to enter the Turkish market, conducts market surveillance for cosmetics, and determines drug pricing policies. The notification of cosmetic products and the control of certain types of biocidal products (such as disinfectants) also fall under the authority of the TMMDA. Notably, since 2023, the authority to oversee and permit all health claims used on food and food supplements has also been transferred to the TMMDA. While not a licensing body, the Turkish Pharmacists Association plays a vital role in importing medicines with no marketing authorization from abroad for individual patient use and regulating professional pharmacy ethics.

Food and Food Supplements: General authority over food and food supplements lies with the Ministry of Agriculture and Forestry (specifically the General Directorate for Food and Control). The Ministry is responsible for setting food safety standards, issuing “approval numbers” after ingredient analysis before supplements are placed on the market, and regulating production and import permits. At the market stage, it inspects food products for compliance with the Turkish Food Codex, conducts inspections for adulteration, and applies sanctions such as product recalls or administrative fines for non-compliant products. Since food supplements are categorized as food, their oversight focuses on “consumer safety and accurate information” rather than the “therapeutic efficacy” criteria used for medicines.
Finally, the Social Security Institution (SSI) acts as the competent authority for reimbursement, determining which of these products are financially covered under the national insurance scheme.

1. Administrative Application and Appeal Procedures

In Türkiye, before filing a lawsuit for the annulment of the act, the interested party may lodge an “administrative appeal” with the issuing or superior authority for the withdrawal, modification, or establishment under the Administrative Jurisdiction Procedures Law (Law No. 2577). This application suspends the statutory period for filing a lawsuit and offers the administration an opportunity to withdraw, revoke, or amend its decision. If the administration (authority) rejects the appeal or is deemed to have implicitly rejected it by failing to respond within 30 days, the process for an annulment lawsuit in the administrative courts commences.

As per Law No. 2577, in cases where no result is obtained from administrative appeal paths or a direct lawsuit is intended to be filed, the authorities to be applied to vary according to the nature of the act:

• Individual Acts: For acts that do not constitute administrative sanctions, an annulment action can be filed in the administrative court within 60 days of notification. If an administrative application was previously made, the remaining portion of the 60-day period begins to run from the notification of the rejection or the end of the 30-day waiting period.
• Regulatory Acts: For the annulment of general regulations such as regulations, communiqués, and guidelines, a lawsuit must be filed with the Council of State within 60 days of the Official Gazette publication or announcement.
• Administrative Sanctions: If the law on which the sanction is based points to administrative jurisdiction (administrative courts), an annulment action is filed within 60 days. However, if no special judicial path is indicated, an application must be made to the criminal judgeship of peace within 15 days of notification.

Particularly in matters where irreparable harm might occur, requesting a “stay of execution” (yürütmenin durdurulması) at the outset of the litigation is critical, as filing an annulment lawsuit does not automatically suspend the implementation of the decision. If the court finds the administration’s decision unlawful, it is annulled with retroactive effect, and the authority is legally bound to comply with the ruling and rectify its action.

2. Specific Appeal Periods for Different Products

Specific appeal periods and procedures determined by TMMDA’s secondary legislation and the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996) exist for different product groups regarding applications for marketing authorization, initial compliance, and facility authorization certificates:

• Medicinal Products for Human Use: In the event of a merits-based rejection of a marketing authorization application, an appeal can be filed before TMMDA within 45 days of the date of notification or announcement. TMMDA will decide on this appeal within 90 days.
• Clinical Trials: For medicinal products for human use, an appeal can be filed before TMMDA within 30 business days against the rejection of the initial compliance application, and within 60 days against the suspension or cancellation of facility authorization certificates.
• Traditional Herbal Medicinal Products: An appeal can be filed before TMMDA within 45 days of notification against the rejection of marketing authorization. TMMDA’s decision period is likewise 90 days.
• Homeopathic Medicinal Products: As with medicinal products for human use, there is a right to appeal against merits-based rejection decisions within 45 days, and the TMMDA shall decide within 90 days.
• Cosmetic Products: An appeal can be made to TMMDA against negative decisions regarding efficacy, safety, or clinical trial applications.
• Medical Devices: The relevant economic operator (manufacturer, authorized representative, importer, etc.) is granted the right to appeal against measures taken by TMMDA regarding medical devices that pose an unacceptable risk to health and safety. TMMDA notifies the operator of the measures, including justifications and information on legal remedies and deadlines.
• Health Claims in Food and Food Supplements: An appeal can be filed within 30 days against decisions to suspend or cancel health claims. TMMDA’s decision period is 30 days.
• Official Control and Inspections of Food and Feed: Appeals against the results of official controls and inspections conducted under Law No. 5996 must be filed within 7 days, primarily to exercise the right to request an analysis of the witness sample.

Clinical trials for medicinal products and medical devices in Türkiye are subject to a strict legal framework that aligns volunteer safety and data integrity with international standards. The primary legal basis for medicinal products is Additional Article 10 of the Fundamental Law on Health Services (Law No. 3359) and the Regulation on Clinical Trials of Medicinal Products for Human Use. For medical devices, the Regulation on Clinical Trials of Medical Devices and the Regulation on Medical Devices, which are harmonized with the European Union’s Medical Device Regulation (MDR), are taken as the basis. The Turkish Medicines and Medical Devices Agency (TMMDA) is the central authority of the process, and all administrative and technical supervision is carried out by this body.

Medicinal Products: When it comes to medicinal products, within the scope of the Regulation on Clinical Trials of Medicinal Products for Human Use, simultaneous applications can be made to the ethics committee and the TMMDA for clinical trials by the sponsor or the designated research organization based in Türkiye. For multi-center trials, the decision of a single ethics committee is sufficient. Provided that the applications are duly submitted and complete, the ethics committee reviews the applications within 12 business days (7 business days for bioavailability and bioequivalence studies), and the TMMDA reviews them within 22 business days (12 business days for bioavailability and bioequivalence studies). In exceptional trial cases, these periods are reduced to 7 business days. If additional information is requested during the application, the requests are communicated all at once, and the applicant must respond within 30 business days. The ethics committee and the TMMDA may issue a negative decision; in this case, the sponsor may make changes and re-apply or appeal within 30 business days. If the appeal is not accepted, the trial approval is considered rejected. The application dossier includes non-clinical data, compliance with Good Clinical Practices (GCP), and authorization documents obtained from international authorities. Under the Regulation on the Licensing of Medicinal Products for Human Use, a six-year data exclusivity period is afforded to the marketing authorisation holder, preventing the authorisation of generic products in Türkiye during this timeframe. This protection is without prejudice to any patent rights that may apply.

Medical Devices: In terms of medical devices, clinical trials are similarly regulated under the Regulation on Clinical Trials of Medical Devices. It is required that the investigational device has been sufficiently tested in a non-human experimental environment or on animals, and that scientific data provides sufficient evidence for clinical trial. Clinical trials are reviewed ethically and scientifically by TMMDA-approved Clinical Trials Ethics Committees. Applications are evaluated by the TMMDA. The TMMDA evaluates whether the application dossier is complete and whether the device’s safety, performance and expected clinical benefit are satisfactory. The TMMDA does not grant permission in case of a negative evaluation. The trial team is led by a Principal Investigator, and the trial is conducted in appropriate health institutions. The regulation stipulates notification periods in the event of security issues arising.

Clinical trials are conducted in appropriate health institutions, prioritizing the rights and safety of volunteers. Any painful or inhumane methods contrary to human dignity cannot be applied to volunteers, and undue financial incentives cannot be provided. Consent of the volunteers can be withdrawn at any stage during the trial process. Moreover, sponsors are required to obtain appropriate clinical trial insurance coverage to compensate participants for any trial-related injuries, as mandated by the clinical trial regulations. Financial incentives cannot be given to volunteers; however, expenses incurred due to participation in the trial may be reimbursed by the sponsor.

Yes, Türkiye maintains a public database for clinical trials. Within the scope of the Regulation on Clinical Trials of Medicinal Products for Human Use, the Clinical Trials Portal is established and operated by TMMDA. Through this portal, information regarding clinical trials and research results is transparently disclosed to the public, provided that trade secrets and the confidentiality of personal data are respected. Additionally, statistical information concerning the number of clinical trial applications and evaluations submitted to TMMDA, as well as summary grounds for rejection decisions, is published in the form of an annual report. However, unless there is a public interest, information on rejected, canceled, or withdrawn clinical trials, as well as data regarding bioavailability and bioequivalence studies, are not published on the portal. The content of the information to be published on the portal is announced on TMMDA’s website, and necessary efforts are carried out to ensure that the published data is in an easily searchable format.

Clinical trial information is recorded, processed, and stored by the sponsor or the research team in an accurate, interpretable, and verifiable manner. The confidentiality of records and the personal data of volunteers is protected in accordance with the applicable personal data protection legislation. Technical and administrative measures are taken to prevent unauthorized access, disclosure, distribution, modification, or destruction. The identity of volunteers cannot be disclosed in the event that research results are published. Furthermore, personal data of volunteers can under no circumstances be made public.

The above matters are governed by the Regulation on Clinical Trials of Medicinal Products for Human Use and the Regulation on Clinical Trials of Medical Devices. Additionally, general provisions regarding the protection of personal data and privacy provided in the Law on the Protection of Personal Data (Law No. 6698) (KVKK) and the Fundamental Law on Health Services (Law No. 3359) are also applicable.

The clinical trial standards in Türkiye are highly aligned with the European Union’s Clinical Trials Regulation.

In Türkiye, the use of data collected from clinical trials is strictly regulated based on the protection of personal data and volunteer rights, and adherence to ethical rules, in accordance with legislation such as the Law on the Protection of Personal Data (Law No. 6698) (KVKK), the Fundamental Law on Health Services (Law No. 3359), the Regulation on Clinical Trials of Medicinal Products for Human Use, the Regulation on Clinical Trials of Medical Devices, and the Regulation on Personal Health Data.

To initiate a clinical trial and process data, both the approval of the relevant Ethics Committee and the authorization of the Turkish Medicines and Medical Devices Agency (TMMDA) are mandatory. The accuracy, reliability, and robustness of the data obtained during the trial are essential, and all processes must be conducted in compliance with Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki, and international standards.

The primary rules to be observed within this scope are as follows:

Informed Consent and Participant Rights: Volunteers participating in a clinical trial are adequately informed in an understandable manner regarding the purpose, methodology, risks, and their rights within the study. Participation is entirely voluntary and volunteers reserve the right to withdraw from the trial at any time without providing any justification”. This consent is obtained in writing; in the event of withdrawal and data collected up to that point may still be used as permitted by law. The physical and mental integrity, privacy, and protection of personal data of the volunteers are strictly safeguarded.

Ethics Committee Approval and Supervision: Clinical trials are initiated only with the favorable opinion of the ethics committee and the approval of TMMDA. Ethics committees operate independently, impartially, and transparently. The conduct of the trial, maintenance of records, reporting, and auditing are overseen by these committees and relevant authorities.

Protection of Personal Data: Since personal data obtained in clinical trials are categorized as “special categories of personal data” under Law No. 6698, stricter security measures are applied in the processing and transfer of such data, ensuring absolute confidentiality. Technical and administrative measures are taken to guard against risks such as unauthorized access, disclosure, modification, or destruction. Data may only be used within the framework of relevant legislation and ethical rules, with the explicit consent of the volunteer or under other conditions prescribed by law. Notably, with the legislative updates in 2024 and 2025, obligations regarding the international transfer of clinical data and the Data Controllers’ Registry (VERBİS) have been further harmonized with the European Union General Data Protection Regulation (GDPR).

Retention of Trial Records and Reporting: All records related to clinical trial must be stored for a certain period of time after the completion of the study. It is a legal obligation to report adverse events and serious adverse effects occurring during the trial to TMMDA within specified short timeframes. In certain risk situations, TMMDA holds the authority to suspend or terminate the trial.

Safety and Urgent Response: In cases where the health of volunteers is jeopardized or ethical rules are violated during the trial, competent authorities have the power to halt or terminate the study. The safety of the volunteers is always the paramount priority.

Compliance with Scientific and Ethical Standards: Clinical trials are designed, conducted, and reported within the framework of international ethical principles (e.g., the Declaration of Helsinki) and relevant national legislation. The scientific benefits of the trial are never prioritized over the health risks of the volunteers.

The digitalization of clinical trial processes in Türkiye is undergoing a comprehensive transformation driven by both current legislative updates and strategic national goals. The legal foundation of this process is established by the Regulation on Clinical Trials of Medicinal Products for Human Use. Specifically, Article 58 of the Regulation explicitly permits digitalization practices in the conduct and organization of clinical trials to adapt to the evolving nature of technology and information infrastructure. It further mandates that the specific procedures and principles of these digital applications be determined through guidelines issued by the Turkish Medicines and Medical Devices Agency (TMMDA).

Digitalization is facilitated by the Clinical Trials Module, established under Article 56 of the same Regulation, and the Electronic Submission and Process Management System within TMMDA. These systems serve as a centralized platform for receiving applications, managing notifications, and electronically archiving and analyzing data. Sponsors are held responsible for keeping all clinical trial information up to date within this module, ensuring transparency and traceability. Notably, as of 2025, the integration of specialized modules for medical device clinical trials and in-vitro performance studies has significantly reduced physical paperwork, digitizing the application phase.

In terms of decentralized clinical trials, the Regulation on Clinical Trials of Medicinal Products for Human Use specifies public training and research hospitals, university health application and research centers, and—provided they are under the coordination or administrative responsibility of these entities—other health institutions and organizations as locations where clinical trials can be conducted. These provisions are intended to facilitate the conduct of clinical trials in a multicenter manner. In fact, the regulations introducing decentralized clinical trials were challenged before the Council of State in previous years on the grounds of being unlawful, and the Council of State upheld the legality of these provisions.

Furthermore, Türkiye is trending toward establishing a framework based on experiences gained during the COVID-19 pandemic. Supported by the Regulation on the Provision of Remote Health Services, this structure paves the way for remote visits, telemedicine applications, and the performance of laboratory tests at local health facilities.

Looking ahead, high-level policy documents such as the Twelfth Development Plan and the 2026 Annual Presidential Program confirm that Türkiye will utilize digitalization as a lever to increase its clinical research capacity. In this context, innovative approaches such as the integration of clinical trial data with electronic health records (like the e-Nabız system), blockchain-based data security solutions, and AI-supported volunteer recruitment remain high on the agenda. The ongoing efforts also aim to ensure alignment with the European Union’s clinical trials legislation.

Medicinal Products: In Türkiye, the authorization processes for manufacturing plants of medicinal products are carried out within the framework of the Law on Pharmaceuticals and Medicinal Preparations (Law No. 1262) and the provisions of the Regulation on the Licensing of Medicinal Products for Human Use and the Regulation on Manufacturing Plants for Medicinal Products for Human Use. For a manufacturing facility to become operational, it must first obtain an authorization from the Turkish Medicines and Medical Devices Agency (TMMDA) and undergo an on-site inspection to confirm compliance with Good Manufacturing Practices (GMP) guidelines. In addition, the facility must appoint responsible manager meeting specific professional requirements.

Medical Devices: The legal framework for medical device manufacturing plants is determined by the Regulation on Medical Devices, which is largely harmonized with European Union legislation, and the Law on Product Safety and Technical Legislation (Law No. 7223). Manufacturers are required to establish a Quality Management System in their plants and ensure that their products bear the CE mark according to their risk classification. Additionally, it is a legal obligation to register both the company and the products in the Product Tracking System (ÜTS) before any manufactured devices are placed on the market. Technical and guarantee service provisions for the medical devices are also subject to scrutiny of TMMDA.

Food and Food Supplements: The authorization of food and food supplement manufacturing plants is under the responsibility of the Ministry of Agriculture and Forestry and is based on the Law on the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996). Plants producing food or food supplements are subject to registration and/or approval depending on the activity and product category. For food supplements, it is also mandatory to obtain ingredient approval and an approval number issued by the ministry for each specific product. Establishing and maintaining a safety system based on Hazard Analysis and Critical Control Points (HACCP) principles is a fundamental legal requirement in these facilities.

The distribution processes for medicinal products, medical devices, and food supplements in Türkiye are subject to a stringent inspection and registration system aimed at protecting public health. These product groups are managed under the control of different regulatory authorities and tracking mechanisms.

Medicinal Products: The distribution of medicinal products is carried out through pharmaceutical warehouses (wholesalers) and pharmacies under the supervision of the Turkish Medicines and Medical Devices Agency (TMMDA), within the scope of the Regulation on the Pharmaceutical Trading House and the Products in Pharmaceutical Trading House. The pharmaceutical distribution channel in Türkiye is a closed system extending from the manufacturer or importer through licensed “Pharmaceutical Warehouses” to pharmacies or hospitals. Pharmacies are exclusively authorized to sell human medicinal products, licensed traditional herbal medicinal products, homeopathic medicinal products, foods for special medical purposes, and infant formulas for special medical purposes. The sale of medicinal products in markets or over the internet is strictly prohibited; all medicines are offered to the public solely through pharmacies. The most critical digital component of this process is the Pharmaceutical Track and Trace System (İTS), where each individual box of medicine is monitored on a unit basis via QR codes from the production line to the end-user. For pharmaceutical warehouses to operate, they must comply with Good Distribution Practices (GDP) standards and integrate their technical infrastructure into this system.

Medical Devices: The distribution process for medical devices is also managed under the supervision of TMMDA, but this time through the Product Tracking System (ÜTS). For a medical device to be placed on the market, both the manufacturer or importer company and the product itself must be registered in the UTS. Distribution transactions are carried out through authorized medical device sales centers. Hospitals, pharmacies, or other healthcare institutions cannot procure a device that is not registered in the UTS or for which a movement notification has not been made through the system. Technical and guarantee service provisions for the medical devices are also subject to scrutiny of TMMDA.

Food Supplements: Food supplements generally fall under the jurisdiction of the Ministry of Agriculture and Forestry and are categorized as “foods.” It is mandatory to obtain approval from the Ministry for the production or importation of these products and to receive a separate approval number for each product. Unlike medicinal products, food supplements can be sold not only in pharmacies but also in approved retail outlets and online. Health claims and advertising activities in the distribution chain are closely monitored by TMMDA and the Advertisement Board to prevent the use of therapeutic expressions.

The procurement of medical devices, medical supplies, medicinal products, and similar goods by public institutions and organizations is conducted in accordance with the Public Procurement Law (Law No. 4734) and relevant legislation. The Directorate General of State Supply Office (DMO) carries out the procurement of medicinal products, medical supplies, and medical devices on behalf of administrations within the framework of determined procedures and principles.

Furthermore, it is well-known that practices such as pharmaceutical companies establishing exclusive selective distribution systems to distribute through a limited number of pharmaceutical warehouses, or the prohibition of selling food supplements through e-marketplaces and the internet, have frequently been brought before the Turkish Competition Board in recent years.

Different regimes are applied within the framework of numerous regulations regarding the pricing and reimbursement of medicinal products for human use, medical devices, and food supplements.

Medicinal Products: For the pricing of medicinal products, a reference pricing method is applied in Türkiye, where the lowest ex-wholesaler selling price applied in France, Italy, Spain, Portugal, and Greece is determined as the reference price. In this system, a fixed Euro exchange rate, updated annually, is used to determine medicine prices. The Price Assessment Commission meets within the first forty-five days of each year to announce the value of 1 (one) Euro to be used in the pricing of medicinal products for human use. As of January 2026, the applied periodical Euro value is 25.33 TRY (1 Euro = 25.33 TRY). However, as of January 2026, when this guide was prepared, a change in the methodology for calculating the aforementioned periodical Euro value is on the agenda, and the sector is cautiously waiting for possible additional updates during the year. In pricing, the prices of reference products constitute the upper limit for the prices of equivalent (generic) products; the price of an equivalent product can be at most 60% of the reference product’s price. For price-protected products, this rate is applied as 80%. The reimbursement of medicinal products is carried out by the Social Security Institution (SSI) within the framework of the Communiqué on Health Implementation (CHI) (Sağlık Uygulama Tebliği – SUT), and cost-effectiveness and budget impact analyses are evaluated for products to be included in the reimbursement list. Additionally, specified wholesaler and pharmacist profit margins are added to the retail prices of medicines, and public institution discounts (discounts for the bulk supplies of SSI) are applied. Furthermore, some innovative treatments are provided through special prices and conditions determined under Alternative Reimbursement Models.

Medical Devices: The pricing and reimbursement of medical devices proceed through unit prices in the Communiqué on Health Implementation (CHI) (Sağlık Uygulama Tebliği – SUT) lists and barcode-based matching rather than a strict reference price model as seen in medicinal products. A reference pricing system is not applied to medical devices, prostheses, or orthoses. For a medical device to be covered by SSI reimbursement, it must first be registered in the Product Tracking System (ÜTS) and approved by the Turkish Medicines and Medical Devices Agency (TMMDA). With the 2026 updates, significant increases have been made in SSI payment limits for products such as ready-made medical supplies used in outpatient treatment and respiratory devices. Reimbursement amounts are generally limited to the ceiling prices specified in the CHI, and any difference above this amount is covered by the patient.

Food Supplements: Prices for food supplements are determined under free market conditions and, as a rule, are not covered by SSI reimbursement. However, “Foods for Special Medical Purposes” constitute an exception to this rule; these products are subject to TMMDA licensing and can be included in the reimbursement list against a medical report for specific disease groups.

In Türkiye, the advertising and promotion of medicinal products, medical devices, and food supplements are subject to strict and specific legal regulations aimed at protecting public health and preventing consumer deception. The primary authority in this framework is the Turkish Medicines and Medical Devices Agency (TMMDA), operating under the Ministry of Health. For food supplements, the Ministry of Agriculture and Forestry also plays a significant role, while the Advertising Board within the Ministry of Trade oversees compliance with general advertising principles.

Medicinal Products: The fundamental rule regarding the advertising of medicines in Türkiye is the absolute ban on advertising to the general public. According to the Law on Pharmaceuticals and Medicinal Preparations (Law No. 1262) and the Regulation on Promotional Activities of Medicinal Products for Human Use, no medicinal product (whether prescription or over-the-counter) can be advertised directly to consumers. Promotional activities may only be directed toward healthcare professionals, such as physicians, dentists, and pharmacists. These promotions must be scientific, ethical, and consistent with the product’s Summary of Product Characteristics (SmPC). Additionally, under the Law on the Establishment of Radio and Television Enterprises and Their Media Law (No.6112), the advertising of medicines on radio and television is strictly prohibited.

Medical Devices: The promotion and advertising of medical devices are regulated by the Regulation on the Sale, Advertising, and Promotion of Medical Devices. This regulation categorizes devices into two groups: those prohibited from public advertising and those that may be advertised under certain conditions. Devices intended solely for use by healthcare professionals or those covered by the social security reimbursement system cannot be advertised to the public. However, devices intended for individual use (e.g., blood pressure monitors, glucose meters, masks) listed in specific annexes of the regulation can be advertised, provided they do not mislead consumers or make prohibited health claims.

Food Supplements: Since food supplements are not classified as medicines, they fall under the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996) and the Regulation on the Import, Production, Processing, and Market Placement of Food Supplements. It is strictly forbidden to claim that these products “treat,” “cure,” or “prevent” diseases in any advertisement. Health claims used in advertising must comply with the Guide on the Use of Health Claims in Food and Food Supplements published by TMMDA. Any visual or auditory elements that lead consumers to perceive these products as medicines are subject to heavy sanctions by the Advertising Board.

Other Legislation and Oversight: Beyond the abovementioned specific rules, the Law on Consumer Protection (Law No. 6502) and the Regulation on Commercial Advertising and Unfair Commercial Practices require that all advertisements remain consistent with public morality, public order, and the principle of honesty. This includes promotions carried out by social media influencers, which must be clearly labeled as advertisements. Violations of these rules can result in administrative fines, suspension of advertisements, or product recalls imposed by TMMDA, the Ministry of Agriculture and Forestry, or the Advertising Board.

In Türkiye, the primary intellectual property legislation governing medicinal products, medical devices, and food supplements is the Industrial Property Law (Law No. 6769). Enacted in 2017, this law consolidated the protections for trademarks, patents, utility models, and designs under a single framework. Registration procedures are handled by the Turkish Patent and Trademark Office (TÜRKPATENT).

Patent rights for inventions in medicinal products and medical devices are protected for 20 years. A critical provision specifically for the pharmaceutical sector is the “Bolar Exception” (IPC Art. 85/3-c), which permits generic drug manufacturers to carry out necessary tests and experiments for regulatory approval while the patent protection is still active, thereby facilitating faster market access once the patent expires including biosimilars. Besides, the 6-year data exclusivity period applied in Türkiye provides protection independent of patent protection.

Trademarks are protected for 10 years, renewable indefinitely. The branding of medicinal products is not solely an intellectual property matter but is also strictly linked to health regulations. The brand names of medicinal products must be approved by the Turkish Medicines and Medical Devices Agency (TMMDA) during the marketing authorization stage; here, the name must not mislead the public about the product’s effects or cause confusion with International Nonproprietary Names (INN). Similarly, while medical devices and food supplements enjoy trademark protection, food supplements must also comply with health claim restrictions and labeling requirements set by the Ministry of Agriculture and Forestry under the Turkish Food Codex Regulation on Food Labeling and Consumer Information.

In conclusion, while the protection mechanism for these products is provided by Law No.6769, their market entry and usage rights are governed by stringent sectoral regulations managed by TMMDA (for medicines and devices) and the Ministry of Agriculture and Forestry (for food supplements). Particularly in the pharmaceutical industry, issues such as data protection and data exclusivity are addressed under the Regulation on the Licensing of Medicinal Products for Human Use, providing an additional layer of administrative protection alongside patent rights.

Legal procedures regarding medicinal product and medical device patents in Türkiye are regulated under the Industrial Property Law (Law No. 6769) and relevant regulations, with judicial decisions significantly guiding the practice. In Türkiye, patent infringements are scrutinized through civil litigation rather than criminal law. Due to the technical expertise required, such cases are generally reviewed before the Civil Courts for Intellectual and Industrial Property Rights located in metropolitan cities such as Ankara, Istanbul, and Izmir. Furthermore, there is no specific administrative authority process or patent-linkage system regarding patent infringement; claims are resolved directly through the judiciary.

In a patent infringement case, the patent owner may file comprehensive claims. Requests may be directed to the court for the determination of infringement; its prevention and cessation; compensation for material and moral damages arising from the infringing acts; and the seizure of products manufactured or imported as a result of the infringement, as well as the means of production.

Unlike trademarks and copyrights, patent infringement is not defined as a crime under Turkish law. Therefore, the legal recourse in the event of an infringement of patent rights consists of compensation and preliminary injunction processes before the civil courts.

Requests for preliminary injunctions are critical tools for the effective protection of patent rights, particularly in the medicinal product and medical device sectors. Within the scope of such injunctions, the immediate cessation of the launching, sale, distribution, commercial storage, use, or import-export of the products subject to infringement can be ensured. Questions such as whether compensation can be awarded in cases of market loss due to the inability to enter the market or loss of earnings due to price decreases resulting from subsequently annulled preliminary injunction decisions are among the significant issues brought before the courts in recent years.

Common Defense Strategies

There are various defense strategies available to parties facing an allegation of patent infringement.

Invalidity of the Patent: In patent disputes within the medicinal product and medical device sectors in particular, the most common tactic of defendants is to assert the invalidity of the patent. As frequently observed in practice, should such an invalidity action be filed, the court prioritizes examining the claims regarding the validity of the patent, and infringement and invalidity actions are often consolidated and heard within the same proceedings.

In addition, the primary defense strategies employed are as follows:

Bolar Exception: Pursuant to Article 85/3-(c) of the Law No. 6769, conducting the necessary tests and experiments for the purpose of obtaining a marketing authorization for a drug, or using the patented invention for experimental purposes, does not constitute an infringement of patent rights. This exception allows generic drug manufacturers to perform the necessary work for marketing authorization applications before the patent term expires, enabling them to enter the market as soon as the patent term ends. Notably, in certain decisions rendered by the courts in 2024 and 2025, the Bolar Exception has been interpreted broadly, and circumstances such as obtaining marketing authorization, price approval for an equivalent medicinal product, and even the inclusion of the product in the reimbursement list of the Social Security Institution (SSI), have been considered within the scope of the exception.

Infringement by Equivalence (Doctrine of Equivalents): Infringement by equivalence is another matter regarding medicinal product patents. Given that generic drugs contain the same active ingredient as the original product and are in similar dosage forms, the principle of equivalence plays a critical role in determining the scope of patent protection. For instance, if there is no change in the effects of a drug despite modifications in its components or formulation, the existence of infringement by equivalence may be established.

Data Exclusivity: Additionally, the 6-year data exclusivity period applied in Türkiye provides protection independent of patent protection. Clinical test data submitted by the original drug manufacturer cannot be referenced by generic manufacturers during this period.

Equitable Defenses and Statute of Limitations: In accordance with general principles of Turkish law, the prohibition of the abuse of rights and the rule of objective good faith (honesty rule) also play a role in patent disputes. For example, if the patent owner remains silent and observes the infringement for a long period, a defense of abuse of rights or forfeiture of rights may be claimed. Furthermore, the statute of limitations provisions in the Turkish Code of Obligations (Law No. 6098) also apply to patent infringement. Claims based on patent infringement must be litigated within 2 years from the date the right holder becomes aware of the infringement and the perpetrator, and in any case within 10 years from the date the infringing act occurred. The defendant may use the expiration of these periods as a statute of limitations defense.

In Türkiye, the use of trademarks on medicinal products, medical devices, food, and food supplements is strictly restricted by both general industrial property law and sector-specific regulations. Although the Industrial Property Law (Law No. 6769) provides the general framework, regulations established by the Turkish Medicines and Medical Devices Agency (TMMDA) and the Ministry of Agriculture and Forestry impose numerous restrictions ranging from trademark selection to presentation on packaging. The primary objective of these restrictions is to prevent the misleading of consumers and to protect public health.

Medicinal Products: Regarding medicinal products, the use of trademarks is subject to the most stringent rules. The brand names of medicinal products must be approved by the TMMDA during the marketing authorization stage. Medicinal product trademarks cannot be so similar as to be confused with International Non-proprietary Names (INN) determined by the World Health Organization or generic names. It is prohibited to use expressions as trademarks that create excessive expectations regarding the therapeutic effect of the drug, misrepresent its safety, or exploit the public’s lack of medical knowledge. In Türkiye, advertising all prescription or non-prescription (OTC) drugs to the public is prohibited.

Medical Devices: The use of trademarks in medical devices must be designed in a manner that does not misrepresent the intended use and technical specifications of the product to consumers or healthcare professionals. It is mandatory for medical devices to be registered in the Product Tracking System (ÜTS) and to bear the CE marking in Türkiye. The trademark or trade name cannot contain misleading claims about the device’s performance. Medical devices may not be advertised in a way that leads to unfair competition or harms the interests of the user, nor by providing information that is false, misleading, exaggerated, or unproven.

Foods and Food Supplements: Similarly, the use of trademarks or expressions containing medical claims such as “heals,” “treats,” or “prevents diseases” on food and food supplements is strictly prohibited. In food supplements, the trademark must be compatible with the product’s content, must not give the consumer the impression that the product is a medicine, and must not encourage excessive consumption. Trademarks, product names, and company names may contain health claims; however, health claims cannot be used for products bearing the same name as a medicinal product, a medical device, or a food for special medical purposes. Furthermore, while there is no requirement to apply for the use of health claims, the responsibility lies with the food business operator. These restrictions were further detailed by the Regulation on the Use of Health Claims in Food and Food Supplements, which came into force in 2023. For instance, where a product’s trademark or brand name constitutes an implicit health claim (e.g., ‘BoneFriendly’), it must be accompanied by a related authorized health claim in accordance with the applicable regulatory framework. Additionally, the use of terms such as ‘bio’, ‘eco’, or ‘organic’ within a trademark or on a label, in the absence of the requisite certifications, is prohibited as it constitutes unfair competition and deceptive marketing practices.

The product liability regime applicable to medicinal products, medical devices, and food supplements in Türkiye constitutes a comprehensive framework in which general product safety legislation, sectoral regulations, and consumer protection laws are intertwined. The primary legal basis of this system is the Law on Product Safety and Technical Legislation (Law No. 7223), which is largely harmonized with the European Union acquis. This Law generally adopts the principle of “strict liability” (kusursuz sorumluluk); accordingly, if damage arises due to a product being unsafe, the manufacturer or the importer is liable to compensate for such damage, regardless of whether they are at fault.

Medicinal Products: With regard to medicinal products, the Regulation on the Withdrawal of Human Medicinal Products and Foods for Special Medical Purposes, which entered into force in 2024, stipulates the procedures for withdrawing defective or risky products from the market by the Turkish Medicines and Medical Devices Agency (TMMDA). A recall decision issued for a drug is considered one of the significant indicators in determining the producer’s legal liability. Since every stage of medicinal products, from production to the end-user, is monitored via the Pharmaceutical Track and Trace System (İTS), breaks in the chain of responsibility can be identified, and faulty batches can be technically segregated with rapid efficiency.

Medical Devices: In the field of medical devices, the liability regime is built upon the European Union’s Medical Device Regulation (MDR) and IVDR regulations, with which Türkiye has largely aligned. Should a defect in a medical device cause bodily harm to a patient, the manufacturer is held liable pursuant to Law No. 7223. Furthermore, technical service liability may be invoked regarding errors related to the installation or maintenance of the device. Manufacturers are obligated to monitor the performance and safety of the device throughout its entire life cycle. The Product Tracking System (ÜTS) utilized in Türkiye ensures the traceability of each individual device, enabling the notification and analysis of adverse events.

Food Supplements: Unlike medicinal products, food supplements fall under the jurisdiction of the Ministry of Agriculture and Forestry and are primarily subject to the provisions of the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996). Liability concerning these products generally centers on “misleading claims” and “ingredient safety.” It is prohibited to promote food supplements as if they were medicinal products or to sell them with therapeutic claims. In the event of health hazards arising from such circumstances, the food business operator may face both administrative sanctions and tort liability.

On the other hand, general provisions regulated under the Law on Consumer Protection (Law No. 6502) and the Turkish Code of Obligations (Law No. 6098) also find application in terms of product liability.

The legal liability regime regarding medicinal products, medical devices, foods, and food supplements in Türkiye has recently been significantly amended and the level of supervision has been increased through amendments introduced by the Law on the Amendments to Certain Laws Related to Health and to the Decree Law No. 663 (Law No. 7557), published in the Official Gazette dated July 24, 2025.

Administrative Liability

Regarding pharmaceutical warehouses, an administrative fine amounting to twice the sale price of the products not reported to the Pharmaceutical Track and Trace System (İTS) is imposed on warehouses that fail to fulfill their notification obligations. In the event that the same violation is committed three times within a single year, the operating license is directly revoked. In the medical device sector, various amounts of administrative fines are applied to those who place or hold counterfeit products on the market, as well as to those providing unauthorized sales, promotion, or technical services.
Liability specific to food and food supplements is structured within the framework the Law on Veterinary Services, Plant Health, Food, and Feed (Law No. 5996). The most significant risk in this field pertains to violations of “health claims.” Administrative fines are imposed by the Turkish Medicines and Medical Devices Agency (TMMDA) and the Advertising Board for advertisements and statements suggesting that a food supplement prevents or treats a disease. Furthermore, Law No. 5996 and its secondary regulations provide for sanctions such as the recall from the market, destruction, and forfeiture to the state of products that may be harmful to human health or are subject to imitation or adulteration, alongside administrative fines.

Criminal Liability

The dimension of criminal liability is directly regulated by the Turkish Criminal Code (Law No. 5237) and relevant special laws. Pursuant to Article 186 of the TCC, individuals who place spoiled or altered food or medicine on the market, or who manufacture or sell medicine in a manner that endangers the life and health of persons, face the risk of imprisonment and judicial fines.
Additionally, regarding medicines and biological products, the production or sale of unlicensed or counterfeit products is a crime directly requiring imprisonment under the Law on Pharmaceuticals and Medical Preparations (Law No. 1262). With Law No. 7557, the production and sale of cannabis-based medicines have been restricted exclusively to pharmacies; any commercial activity outside this scope has been included within the risk of aggravated imprisonment under the legislation on narcotic drugs and psychotropic substances.

Civil Liability

The Law on Product Safety and Technical Legislation (Law No. 7223) has established a structure similar to the principle of “strict liability” in Türkiye. If a product (medicine, medical device, or food) causes damage to a person or property due to being unsafe or misleading, the manufacturer or importer is liable to compensate for such damages. Furthermore, general provisions regulated by the Law on Consumer Protection (Law No. 6502) and the Turkish Code of Obligations (Law No. 6098) remain fundamental regarding civil liability.

Digital health applications and medical software in Türkiye are governed by a multi-layered legislative framework. The e-Nabız (Personal Health Record System) serves as the centralized national infrastructure for digital health. It is primarily regulated under the Regulation on Personal Health Data. Any digital health application operating within this jurisdiction must comply with the technical and legal standards established by the Ministry of Health to ensure interoperability and data security within this national ecosystem.

If a mobile application or software is utilized for a medical purpose—such as diagnosis, treatment, monitoring, or mitigation of a disease—it falls within the scope of the Regulation on Medical Devices, which is harmonized with European Union standards (EU MDR). Under this framework, such software is classified as “Software as a Medical Device” (SaMD). Prior to market entry, these products must bear the CE mark (contingent upon their risk classification), maintain a comprehensive technical file, and be registered in the Product Tracking System (ÜTS) of the Turkish Medicines and Medical Devices Agency (TMMDA).

Pursuant to the Fundamental Law on Health Services (Law No. 3359), healthcare institutions are required to record personal health data electronically and transfer it to the central health data system in compliance the Law on the Protection of Personal Data (Law No. 6698) (KVKK) and related legislation.

Regarding the delivery of digital health services, the Regulation on the Provision of Remote Health Services, which entered into force in 2022, plays a critical role. This regulation defines the conditions for providing remote health services, the authorization of healthcare facilities, patient disclosure requirements, and technical infrastructure standards. Accordingly, platforms must use secure data systems approved by the Ministry of Health, and practitioners must adhere to specific ethical and professional codes of conduct.

In terms of data privacy, digital health applications are strictly bound by Law No. 6698 and the Regulation on Personal Health Data. As health data is categorized as “special categories of personal data” (sensitive data), stringent protective measures and explicit consent mechanisms are mandatory for its processing and transfer. Notably, following the amendments made at the end of 2025, significant regulations were introduced regarding access authorization, confidentiality protocols, and the management of health data for minors and persons with disabilities.

Furthermore, the Regulation on Promotion and Information Activities in Health Services (updated in late 2025) has imposed strict limitations on digital information and advertising, including the use of visual content, sponsored posts, and promotional campaigns. Administrative and criminal sanctions are envisaged for non-compliance with these provisions. Furthermore, the Regulation has also imposed severe restrictions on information and advertising activities conducted via digital platforms, including the use of visual content, sponsored content, and announcements regarding discounts or campaigns. Administrative and criminal sanctions are envisaged in the event of non-compliance with the provisions herein.

In Türkiye, a comprehensive legal framework and digital tracking systems are in place to ensure the security of supply for medicinal products and medical devices that mostly restricts conventional parallel imports. While the foundation of this field is established by the Law on Pharmaceuticals and Medicinal Preparations (Law No. 1262) and the Fundamental Law on Health Services (Law No. 3359), the primary authority responsible for implementation is the Turkish Medicines and Medical Devices Agency (TMMDA). By mandating the licensing (marketing authorization) or registration of medicinal products and medical devices prior to their placement on the market, the legislation aims to ensure that only safe and effective products enter the supply chain.

Specifically, for medicines of critical importance or those unavailable within the country, the “procurement of medicines from abroad” mechanism is operated. Through a specialized “named patient” system, medicines required by patients but not licensed or available in Türkiye are imported under special authorization via the Turkish Pharmacists’ Association (TEB) and the Social Security Institution (SSI), thereby maintaining continuity of supply.

TMMDA is tasked with issuing regulations, taking necessary measures, and imposing sanctions where necessary to ensure the continuous availability and supply of products within its jurisdiction. Within this scope, TMMDA may resort to measures such as banning the export of products experiencing supply shortages. Such measures were notably implemented during the COVID-19 pandemic. Under the Regulation on Medical Devices, manufacturers are under an obligation to provide prior notification to the TMMDA and relevant parties regarding devices for which an interruption or discontinuation of supply is anticipated.

On the other hand, the “Communiqués on Product Safety and Inspection” ensure the guarantee of supply and availability through legal mechanisms such as monitoring the movements of human medicinal products and medical devices within the supply chain, inspecting their compliance, and recalling unsafe products from the market. These communiqués contribute to the protection of public health by inspecting the compliance of products with technical regulations, taking measures against products carrying risks, and regulating the inspection powers of authorized bodies. Furthermore, they ensure the presence of safe products on the market by imposing restrictions on the sale and promotion of medical devices.

In Türkiye, the promotion of medicinal products is generally carried out within the framework of the Regulation on Promotional Activities of Medicinal Products for Human Use. Under these regulations, the direct-to-consumer promotion or advertising of prescription medicines is strictly prohibited; promotional activities may only be conducted for healthcare professionals, such as physicians, dentists, and pharmacists. Furthermore, promotion for uses outside the scope of the approved Summary of Product Characteristics (SmPC) (off-label use) is also prohibited.

Regarding medical devices, the primary regulation is the Regulation on Sale, Advertising, and Promotion of Medical Devices. This regulation prohibits advertising to the public for devices that must only be used by healthcare professionals or those that require application within medical device sales centers. While certain products may only be advertised to consumers on the internet platform where the device is sold, the advertising of products listed in Annex 3 of the Regulation may be freely conducted for consumers.

In both sectors, matters such as support for scientific meetings for healthcare professionals, the principles of operation for product promotion representatives, distribution of samples, and the maximum monetary value of promotional materials are governed by detailed guidelines issued by the Turkish Medicines and Medical Devices Agency (TMMDA). Additionally, compliance with Good Distribution Practices (GDP), which sets out the standards and rules to ensure the safe, high-quality, and legally compliant distribution of medicines and medical devices within the supply chain, is mandatory.

In addition to legal regulations, pharmaceutical industry associations in Türkiye establish their own ethical codes to maintain sectoral discipline. Ethical codes and promotional principles defined by organizations such as the Association of Research-Based Pharmaceutical Companies (AİFD), the Pharmaceutical Manufacturers Association of Türkiye (İEİS), the Turkish Pharmaceutical Industry Association (TİSD), and the Association of Research-Based Medical Technologies Manufacturers (ARTED) encourage their members to adhere to ethical standards. These codes include detailed rules on various subjects, including competition between companies, relations with healthcare professionals, the use of digital platforms and social media, relations with patient organizations, and sponsorship of scientific events. In case of a violation, disciplinary actions or sanctions—ranging from the suspension of membership to expulsion from the association—can be imposed by the boards within these associations.

Significant developments have recently occurred in the field of life sciences in Türkiye, driven by both judicial precedents and decisions rendered by independent administrative authorities.

Access to Innovative Therapies Through Court Decisions: Divergence Between the Approaches of Superior Courts: Prominent judicial developments include decisions issued by the Constitutional Court, administrative courts, and the Court of Cassation regarding lawsuits filed by individuals seeking reimbursement from the Social Security Institution (SSI) for medications used in the treatment of cancer and rare diseases that are not currently on the reimbursement list. In their well-established precedents, the Constitutional Court and administrative courts have ruled that the costs of innovative treatments—which are either not on the SSI reimbursement list or are classified as “off-label”—must be covered by the SSI within the scope of the right to life and the right to social security. These courts have granted such coverage from the outset of the proceedings and throughout the treatment period through mechanisms such as stay of execution or interim injunctions. Conversely, due to jurisdictional rules, cases heard before the civil judiciary have seen a different trend. Decisions rendered by the Court of Cassation in 2024 and 2025 have established that medication costs cannot be covered via preliminary injunctions at the very beginning of a lawsuit. Regarding the merits of the case, the Court of Cassation has set forth remarkably stringent criteria for the reimbursement of medication costs through litigation, in a manner that may result in the grievance of patients.

The Council of State’s Decision on “Internal Reference Pricing”: In July 2025, the 10th Chamber of the Council of State decided to suspend the execution of certain provisions in the Communiqué on Health Implementation (CHI) (Sağlık Uygulama Tebliği – SUT) that envisaged an “internal reference pricing” mechanism. The provisions in question stipulated that various drugs with different active ingredients could be evaluated within the same equivalent group, and reimbursement would only be made up to 5% above the price of the cheapest drug in that group. Subsequently, in November 2025, a new decision by the Health Services Pricing Commission amended the CHI, increasing this margin to 6% above the cheapest drug. Relevant professional organizations have already filed lawsuits seeking a stay of execution for this new regulation as well.

The Euro Exchange Rate Decision: In addition, pursuant to the Amending Decree on the Pricing of Human Medicinal Products published in December 2025, the Euro exchange rate used in medicine pricing was updated with a 16.9% increase. Consequently, the applicable rate has been set at 1 EUR = 25.33 TRY. It remains uncertain whether a further adjustment will be made for 2026, and it is anticipated that a fundamental change in the pricing methodology may be placed on the agenda.

The Turkish Competition Authority’s Fines on Pharmaceutical Companies for Labor Market Related Infringements: Another notable development in the sector is the extensive investigation conducted by the Turkish Competition Authority regarding the labor market, which involved several undertakings primarily operating in the pharmaceutical industry. Concluded by the Turkish Competition Board in September 2025, the investigation found that certain pharmaceutical companies had entered into no-poaching agreements and/or engaged in concerted practices. Furthermore, some companies were found to have exchanged competitively sensitive information regarding future employee salaries and side benefits. As a result, administrative monetary fines totaling approximately 245 Million TRY were imposed.

The digitalization of the healthcare system and the utilization of artificial intelligence in the life sciences sector in Türkiye are undergoing a transformation accelerated by comprehensive strategic plans and new legislative regulations published in recent years. The Twelfth Development Plan (2024-2028) and the Strategic Plan of the Ministry of Health constitute the cornerstones of Türkiye’s vision for digitalization in health.

Within this framework, the scope of centralized systems such as e-Nabız (Personal Health Record System) is being expanded to enhance efficiency in healthcare delivery, and data flow is being optimized through practices such as the full integration of family doctors into hospital laboratory and imaging systems as of 2025. Furthermore, it is established that initiatives are underway to utilize anonymized e-Nabız data for AI development and R&D activities.

Moreover, the Regulation on the Provision of Remote Health Services has defined the procedures and principles regarding the scope of telemedicine services, the authorization of health facilities to provide remote health services, and the development, registration, and auditing of remote health information systems.

Regarding AI specifically, while Türkiye does not yet possess a standalone “Artificial Intelligence Law,” the Directorate General of National Technology and Artificial Intelligence—established by Presidential Decree No. 191 dated December 25, 2025 is mandated with the authority to develop policies for the ethical and secure use of these technologies. On the other hand, it has been emphasized in various documents that the Social Security Institution (SSI) is deploying AI-supported risk analysis systems to prevent irregularities in reimbursement processes.

Data privacy constitutes the most critical legal component of this process. Significant amendments made to the Law on the Protection of Personal Data (Law No. 6698) (KVKK) in 2024 and 2025 have aligned the conditions for processing special categories of personal data and cross-border data transfer mechanisms with the EU’s GDPR standards. These amendments have substantially resolved the challenges regarding international data transfers. In particular, the new guidelines and “adequacy decisions” published by the Turkish Personal Data Protection Board serve as the primary framework for the utilization of health data in training AI models or the transfer of data abroad within the scope of international clinical trials. Additionally, the Regulation on Promotion and Information Activities in Health Services, which entered into force in November 2025, has introduced stringent restrictions on information and advertising activities conducted via digital platforms, including the use of visual content, sponsored content, and announcements regarding discounts or campaigns.

Following the July 2025 amendments to the Law on the Control of Narcotic Substances (Law No. 2313), two landmark regulations—the Regulation on Cultivation and Control of Cannabis and the Regulation on Products Derived from Cannabis—were published on January 31, 2026. This secondary legislation establishes a comprehensive framework for medicinal, health, support, and personal care products (cosmetics) derived from cannabis. Key highlights include a strictly controlled licensing regime by the MoH and TMMDA, a 0.3% THC threshold for non-narcotic products, and a mandatory pharmacy-only sales channel for all categories. Notably, the framework emphasizes domestic cultivation, potentially restricting the use of imported cannabinoids. With these regulations now in force, a structured legal pathway has been established for the introduction of cannabis-derived products into the Turkish market under a robust electronic tracking system. While the entry into force of these regulations marks a significant milestone, the industry now awaits further technical guidelines from the TMMDA to clarify the practical implementation.

Furthermore, it is expected that the scope of immunotherapies and innovative treatments reimbursed by the Social Security Institution (SSI) will be expanded on a product and indication basis, and that the implementation of alternative reimbursement and value-based reimbursement models will increase in the upcoming period.

On the digital front, it is considered that laws and regulations concerning artificial intelligence applications may be enacted; however, these may diverge from EU legislation in certain aspects. Moreover, new regulations are expected to be put into effect to provide access to digital health services and personal health data for purposes such as innovation, research, and regulation.

Finally, it is expected that efforts led by public and non-governmental organizations toward the localization of production processes and supply chains, particularly in the pharmaceutical sector, will continue with the aim of ensuring security of supply and strengthening domestic production capacity.