Key Changes In Named Patient Program

Pharmaceuticals not authorized in Turkey or authorized pharmaceuticals not available in the market, shall be procured from abroad as per a special authorization (named patient program) in cases where patients require such pharmaceuticals.

While this exceptional import regime for pharmaceuticals was until recently regulated by the Medicines and Medical Devices Agency ("Agency") through guideline, the Regulation on Supply of Pharmaceuticals from Abroad ("Regulation") was published in the Official Gazette dated 3 February 2023 and numbered 32093. The Guideline on Supply of Pharmaceuticals from Abroad ("Guideline"), which contains the guiding provisions regarding the implementation of the Regulation, was once again updated on 22 September 2023, after being updated in April.