Healthcare 101 in Turkey
Essentials in the Healthcare Sector
What are the regulatory bodies in the healthcare sector?
The regulatory bodies governing the Turkish healthcare system and pharmaceutical market are the Turkish Pharmaceuticals and Medical Devices Authority (tr. “TITCK“) under the Ministry of Health and the Social Security Institution (which operates under the Ministry of Labor and Social Security).
The TITCK conducts the following activities:
- It regulates the manufacturing, import and marketing authorizations of medicines for human use, and ensures that they are of a high quality and reasonable price.
- It regulates manufacturing, distribution and warehousing facilities and pharmacies dealing with medicine and medical substances.
- It regulates imports, manufacturing, exports and local consummation of narcotic and psychotropic substances.
- It approves the Turkish pharmacopeia entering into force.
- It executes other similar duties to be granted by the Ministry of Health.
What is the main requirement for placing pharmaceuticals on the Turkish market?
In principle, healthcare companies must obtain marketing authorization to place their pharmaceutical products on the Turkish market. The marketing authorization requirement is mainly regulated under the Regulation of Marketing Authorization for Pharmaceuticals (“MA Regulation“), which is parallel with EU DIR 2001/83/EC.
Certain types of medicines, (e.g., pharmacy-prepared medicines, medicinal products intended for research and development trials, intermediate products, radionuclides and whole blood, plasma or blood cells of human origin) are excluded from the scope of the MA Regulation.
In addition, it is obligatory to obtain a sales permit for placing on the market the products with marketing authorization by the TİTCK.
How do I apply for marketing authorization?
The first option for obtaining regular (commonly known as original product) marketing authorization is applying to the TITCK. Another option is applying for generic marketing authorization (i.e., an application without submitting the results of preclinical tests and clinical trials) in certain cases, including the following:
- If the relevant medicine is similar in essence to another medicine holding marketing authorization and the marketing authorization holder of the latter medicine consents to the use of its products’ preclinical tests and clinical trials
- If the relevant medicine is similar in essence to another medicine holding marketing authorization and the data exclusivity period of the latter product has ended
- If the component(s) of the medicinal product have been in well-established medicinal use, with recognized reasonable efficacy and an acceptable level of safety as a result of a detailed scientific bibliography
How do I change the marketing authorization holder?
Transferring the marketing authorization holder is one of the practical issues, especially in cases where a pharmaceutical company intends to terminate its current distributor relationship and enter direct into the Turkish market. According to Article 26 of the MA Regulation, among other things, the Ministry of Health requires either a notarized agreement on the transfer of the marketing authorization among the current and prospective marketing authorization holder on the transfer or a court decision on the change of the marketing authorization holder. Therefore, if a pharmaceutical company wishing to terminate its distribution relationship in Turkey and appoint a third party or its subsidiary in Turkey — as this would also require a change of the marketing authorization holder — a simple termination of the current distributor would not be sufficient. Rather, a bilateral agreement between the current and prospective marketing authorization holder before a notary public, a decision that the marketing authorization is sold through compulsory enforcement procedures or a court decision granting the termination right would be required.
Can I advertise my pharmaceuticals in Turkey?
The promotional activities on medicinal products are restricted under the relevant legislation. Accordingly, medicinal products can only be promoted as follows:
- In publications sold/distributed to healthcare professionals or publications in scientific medical or professional magazines
- By product promotion personnel visits to medical doctors, dentists and pharmacists, and by informing other healthcare professionals of the implementation and side effects of the products
What are the rules for medical devices?
Medical devices are regulated under the new Medical Devices Regulation (MDR), which came into force on 2 June 2021. Unlike medicinal products, medical devices do not require marketing authorization to be placed on the market. According to the MDR, medical devices require registration on the Product Tracking System (Ürün Takip Sistemi). In addition, the MDR implements the European Database on Medical Devices (EUDAMED) system of the European Commission to enhance transparency and improve traceability in the medical device industry. Accordingly, the MDR introduces obligations for manufacturers, importers and authorized representatives to file registrations with EUDAMED.
Can I advertise my medical devices?
The promotion of the following medical devices to consumers is prohibited pursuant to the Regulation on Sale, Advertising and Promotion of Medical Device Sales:
- Devices sold, adapted or applied only in hearing aid centers, bespoke prosthetics and orthotics centers, opticians offices or dental prosthetic laboratories
- Devices that are intended to be used or applied exclusively by healthcare professionals or that require an application in medical device sales centers
Medical devices used for personal hygiene (e.g., toothpaste, cottons, etc.) may be promoted freely. Remaining medical devices may only be promoted to consumers through the website where the device is sold.
Do I have to obtain authorization for cosmetics?
Unlike medicines and medical devices, placing cosmetics on the market is subject to a notification to the TITCK as per the Cosmetics Law.
Can I advertise my cosmetics products?
The promotion of cosmetics is subject to certain rules and restrictions. Accordingly, the promotion must not include expressions implying that diseases will be treated and/or prevented or that a physiological function will be corrected, regulated and/or altered.
