On 10 January 2020, the Turkish Medicines and Medical Devices Agency published the new Guidelines on the named patient programme (Turkish language). The guidelines include some changes regarding the implementation of the named patient programme (NPP). The outstanding amendments can be found below:
- Uluslararası Sağlık Hizmetleri A.Ş. (USHAŞ), a public enterprise established by law, was added as a supplier of the NPP. It joins the Turkish Pharmacists Association (TEB) and the pharmaceutical warehouse, İbn-i Sina, of the Social Security Institution (SGK).
- Only active ingredients that are supplied from abroad will be published. Other products supplied from abroad will no longer be published.
- Only products manufactured in member countries of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) will be supplied from abroad.
- The responsibility for the risks that may arise in terms of patient health due to the supplied medicines are now clearly imposed on USHAŞ, the TEB and the SGK.
- The Turkish Medicines and Medical Devices Agency has the right to conduct any kind of examination and research, including good manufacturing practices inspections, on human medicinal products supplied from abroad by the NPP, if deemed necessary.
The guidelines haves been in force since their publication. Therefore, the agency has ceased publishing the list of products supplied from abroad and has already published three new lists on active ingredients supplied from abroad.
First published by Practical Law, in 29.02.2020