On 23 October 2021, the Turkish Medicines and Medical Devices Agency (the Agency) published its amended guideline on the named patient programme (Turkish language) (guideline). The most important amendments concern the bodies authorised to supply foreign drugs and the countries from which products can be supplied.
The range of bodies authorised to supply foreign drugs has been broadened, and now in addition to the International Health Services (USHAŞ), Turkish Pharmacist Association (TEB) and Social Security Institution (SSI), it includes government agencies and institutions which are deemed suitable for foreign drug supply by USHAŞ, TEB, SSI and the Agency. The names of the new suppliers have not been published yet.
Prior to the amendment, the products which were supplied had to be authorised by the Food and Drug Administration, the EMA or a Pharmaceutical Inspection Co-operation Scheme member country and placed on the market in these countries. Currently, the guideline states that only a product which is licensed and placed on the market with proof that it has scientifically acceptable efficacy, quality and safety by the following bodies can be supplied:
- The competent authorities of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use members.
- The Medicines and Healthcare products Regulatory Agency (the UK's competent authority).
- The Therapeutics Good Administration (Australia's competent authority).
Products that do not comply with the criteria will be delisted from the Foreign Drug List.
The guideline is in force from 23 October 2021.
First published by Practical Law in Dec 02, 2021.