New Guidelines on Named Patient Programme

In Turkey, the law explicitly states that pharmaceuticals which have their safety and efficacy proven through sufficient scientific and clinical studies within the direction of existing treatment guides, and are granted market authorisation by the Turkish Medicines and Medical Devices Agency (“Agency”) must be supplied only by pharmacies. However, the Agency is also competent to determine the exceptional importation regimes. Named Patient Program (“NPP”) is one of the exceptional importation regimes of pharmaceutical products without marketing authorization in Turkey or with marketing authorization but which are unavailable on the Turkish market for various reasons.

On 10 January 2020, the Agency published the New “Guidelines on the Supply and Use of Pharmaceuticals from Abroad” (“Guidelines”). The Guidelines includes some amendments regarding the execution of the NPP. The outstanding amendments can be found below:

  • Among the suppliers of the NPP, Uluslararası Sağlık Hizmetleri A.Ş. (“USHAŞ”), a public enterprise established by law, was added next to Turkish Pharmacists Association (“TEB”) and Social Security Institution’s pharmaceutical warehouse named İbn-i Sina (“SSI”).
  • Only the active ingredients which are supplied from abroad will be published, the list of the products supplied from abroad will no longer be published.
  • Only the products manufactured in PIC/s member countries will be supplied from abroad.
  • The responsibility on the risks that may arise in terms of patient health due to the supplied medicines is now clearly burdened on USHAŞ, TEB and/or SSI.
  • The Agency clearly regulated its right to conduct any kind of examination and research, including GMP inspection, on human medicinal products supplied from abroad by the NPP, if deemed necessary.

The Guidelines has been in force as of the publication. As of the publication of the Guidelines, the Agency has ceased to share the list of the products supplied from abroad and already published new lists on active ingredients supplied from abroad.

The NPP procedures have changed as of 2014 until today and the amendments show that the Agency changed the procedures for a confidential execution.

First published by Practical Law, in 29.02.2020