Turkey Law No. 1262/1928 on Pharmacies and Pharmaceuticals (published in the Official Gazette numbered 898 and dated 26 May 1928) is the main legislation regulating the marketing, authorisation and pricing of pharmaceutical products.

Licensing of pharmaceuticals including biosimilar and generic drugs is executed according to the Licensing Regulation on Medicinal Products for Human Use (Licensing Regulation), which was published in the Official Gazette No. 25705 on 19 January 2005 and is made in close connection with the Directive 2001/83/EC of 6 November 2001 on the Community Code relating to Pharmaceutical Products for Human Use. According to the Licensing Regulation, in Türkiye, medicinal products for human use are to be licensed. While the licences are granted by the Ministry of Health, licences for licensing and marketing of pharmaceuticals are separately required. To establish the licensing criteria for similar biological medicinal products, The Guidelines for Similar Biological Medicinal Products were entered into force in 2008.