The healthcare sector is an area in which every stage, from a product's launch to its reaching the patient, is subject to authorisation and inspection. Pharmaceutical and medical device companies, pharmaceutical wholesalers, hospitals and digital health ventures are subject to different regulations, but what they have in common are detailed rules laid down to protect public health and the serious consequences of breaching them. The sector's main regulator is the Turkish Medicines and Medical Devices Agency (TİTCK).
Medicines and medical devices
Placing medicinal products for human use on the market requires a marketing authorisation from TİTCK under Law No. 1262 on Pharmaceutical and Medicinal Preparations and the licensing regulations based on it. The process covers assessment of data on the product's quality, safety and efficacy, the suitability of the manufacturing site and approval of product information. After authorisation, pharmacovigilance (monitoring of drug safety), variation applications and pricing procedures continue.
Medical devices are subject to the Medical Device Regulation, prepared in line with European Union legislation within the framework of Law No. 7223 on Product Safety and Technical Regulations. Depending on the device class, obligations arise such as conformity assessment, review by a notified body, CE marking and registration in the product tracking system. The obligations of manufacturers, importers and distributors are distinct; each company in the supply chain must correctly identify its own role.
Clinical trials and promotion
Clinical trials on human subjects require ethics committee approval and TİTCK authorisation. Informed consent of volunteers, insurance obligations and protection of trial data are the core elements of clinical trial agreements. Promotion of medicinal products for human use is also subject to strict rules: advertising prescription products to the public is prohibited, and promotional activities aimed at healthcare professionals must be carried out within the limits of the relevant regulation. Support provided to physicians, congress attendance and distribution of samples are the matters most frequently inspected in this context.
Health data
Health data is a special category of personal data under Article 6 of Personal Data Protection Law No. 6698. Following the 2024 amendment, the cases in which these data may be processed other than with explicit consent were reorganised; one of these is processing by persons under a duty of confidentiality or by authorised institutions for the purposes of protecting public health, preventive medicine, medical diagnosis and the provision of treatment and care services. Digital health applications, telemedicine services and research projects involving health data are subject, in addition to these rules, to regulations specific to health legislation.
Healthcare institutions and liability
Private healthcare institutions are licensed and inspected under Basic Law on Health Services No. 3359 and the related regulations. Contracts with physicians, partnership structures, service procurement and promotional activities outside the institution should be assessed separately. In damage arising from medical intervention, the basis of liability varies according to the institution providing the service: in private healthcare institutions, the relationship between patient and institution is generally assessed under the rules on contracts of mandate, while for public hospitals a full remedy action based on service fault is filed in the administrative courts. Law No. 1219 on the Practice of Medicine and Its Branches contains the basic rules on professional practice.
Our firm's work in this sector
We work on licensing and compliance procedures for pharmaceutical and medical device companies, distribution and clinical trial agreements, health data compliance and corporate transactions of healthcare institutions. This work combines our practice in Personal Data Protection, Intellectual Property, Commercial and Corporate Law and Dispute Resolution.
Main topics
- Marketing authorisation of medicines and TİTCK procedures
- Placing medical devices on the market
- Clinical trials and ethics committee approvals
- Promotion and advertising rules
- Processing of health data (KVKK Art. 6)
- Healthcare institutions' contracts and liability actions
Frequently asked questions
Can a prescription medicine be promoted on social media?
Promotion of prescription medicinal products for human use to the public is prohibited. Promotional activities may be addressed only to healthcare professionals, within the limits of the relevant regulation.
What are the obligations of a medical device importer?
The importer must check that the device has undergone conformity assessment, that the manufacturer has fulfilled its obligations and that the device has been registered in the product tracking system. It must also comply with storage and transport conditions and report adverse events.
Is explicit consent always required to process health data?
No. Following the 2024 amendment to KVKK Art. 6, explicit consent is not required in certain cases, such as processing by persons under a duty of confidentiality for purposes such as medical diagnosis and treatment. However, whether each processing activity falls within one of these cases should be assessed separately.
I was harmed by treatment at a public hospital. Where is the action filed?
For damage arising from services provided at public hospitals, a full remedy action is filed against the administration in the administrative courts on the basis of service fault. For private healthcare institutions, the civil courts have jurisdiction.
What approvals are needed before starting a clinical trial?
Clinical trials with medicinal and biological products require both a favourable opinion of the competent ethics committee and authorisation from the Turkish Medicines and Medical Devices Agency under the Regulation on Clinical Trials. Volunteers' written informed consent must be obtained and, where required by the legislation, trial-specific insurance must be taken out. Medical device investigations are subject to separate rules.
Legislation and sources
- Law No. 1262 on Pharmaceutical and Medicinal Preparations (in Turkish)
- Law No. 7223 on Product Safety and Technical Regulations (in Turkish)
- Personal Data Protection Law No. 6698 (in Turkish)
- Turkish Medicines and Medical Devices Agency
The information on this page is general and does not constitute legal advice. As legislation may change, the current rules must be assessed separately for your particular situation.