Named Patient Programs is one of the exceptional importation regimes of pharmaceuticals without marketing authorization in Turkey or with marketing authorization, but which are unavailable in the Turkish market for various reasons.

Article 85(3)/(c) of the Industrial Property Law No. 6769 regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof.

After the long-awaited Regulation on Medical Devices numbered 2017/745, prepared by the EU Commission, has entered into force, Medical Device Regulation, which was designed following MDR, was published in the Official Gazette numbered 31499 on June 2, 2020.

Standard-Essential Patents are the concept arising from the interaction between patent rights, which provide exclusive use of an invention and “standards” aimed at the widespread and mandatory use of this innovation in the relevant market.

Telemedicine is one of the areas that are not explicitly regulated under Turkish law. Within the scope of the existing legal framework, the Medical Deontology By-law and Ethical Principles for Physicians prohibit remote examination, diagnosis, and treatment of patients.

On 28 September 2022, the Turkish Medicines and Medical Devices Agency (Agency) published guidelines (Turkish language) on donation from abroad of human medicinal products that are not approved in Turkey on its official website.