Removal of Products From Named Patient Programme List

The Turkish named patient programme (NPP) is an exceptional importation regime for pharmaceutical products. Following a 5 December 2018 amendment to Law No 984 on Commercial Pharmaceutical Warehouses and Shops that Sell Poisonous Chemical Substances Used in Arts and Agriculture (Law on Warehouses), it is mandatory to apply for marketing authorisation within three years of a drug's inclusion on the NPP list. It is also mandatory to obtain marketing authorisation within two years from the date of application for marketing authorisation. Once those deadlines have passed, the President of the Republic is authorised to decide on the continuation of the supply of drugs that did not obtain a marketing authorisation or for which no marketing authorisation application was filed.

For products supplied from abroad prior to the entry into force of the amendment, the application period for marketing authorisation is calculated from 5 December 2018.

As mandated, on 24 November 2021, the Turkish Medicines and Medical Devices Agency announced (Turkish language) the products which have completed their three-year period of listing on the NPP List and the products which have six months left to complete of that three-year period.

The products announced will be evaluated by the Foreign Drug Evaluation Commission and those deemed suitable to remain on the NPP List will be submitted for the President's approval.

There are no criteria set for the evaluation to be made by the Foreign Drug Evaluation Commission or by the President.

First published by Practical Law Life Sciences Monthly Newsletter in Jan 05, 2022.

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