Guidelines on Named Patient Programme Amended in 2021

The Turkish Medicines and Medical Devices Agency's guidelines on the Named Patient Programme (Turkish language) explains the procedure for the supply from abroad of drugs that are not authorised in Turkey or not available on the Turkish market. The guidelines were first published in 2014, amended in 2015, 2017 and 2020, and finally published in the most current version on 9 August 2021.

The latest amendment made to the guidelines introduces the definition of generic products as medicines containing the same active substance in the same amount, in the same or similar form. Accordingly, a bioequivalence study must be conducted for applications to procure medicinal products which:

  • Are not authorised by FDA or EMA or in a PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) member country or not produced in facilities that have been given a certificate of conformity pursuant to GMP inspection made by the Agency or PIC/S member country.
  • Have at most one generic product.

In addition, these medicinal products must be available on the market in a country/countries with a population greater than the population of Turkey in total or independently.

First published by Practical Law, in 02.09.2021

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