Named Patient Program

Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization in Turkey or with marketing authorization, but which are unavailable in the Turkish market for various reasons.

In cases where a pharmaceutical does not have a marketing authorization in Turkey or has a marketing authorization but cannot be found on the market, and patients need the pharmaceutical in question, it is possible to procure the pharmaceutical via this particular method upon the request of a physician. The program is regulated by the Guidelines published by the TMMDA until 2023.

On February 03, 2023, the Regulation on the Supply of Medicines from Abroad (“NPP Regulation”) was published in the Official Gazette with the number 32093. Before the publication of the NPP Regulation, allegations of counterfeit products supplied recently appeared in the news, and the TMMDA and SSI made press statements on this issue. It is also stated in the press releases that criminal complaints have been filed against those involved in the supply of counterfeit products. As a result of these developments, the NPP Regulation has been published, and the roles of stakeholders in the procurement process have been defined more clearly:

• Foreign institutions and organizations that will supply medicines from abroad have been identified as Foreign Medicine Supply Sources, and it has become mandatory for them to have a Representative in Turkey.
• The representative is defined as a natural or legal person residing in Turkey who has been authorized in writing to fulfil the obligations of the Foreign Medicine Supply Source on its behalf.
• It is stipulated that the Turkish Pharmacists Association, the SSI and the public institutions deemed appropriate by the Ministry, which will supply the product from abroad, will distribute the products in accordance with the legislation to which pharmaceutical warehouses are subject.

In addition, it has been provided that the products procured through these means will be registered to the Medicine Monitoring System (“ITS”), just as it is done for licensed medicines, and will be tracked through this system.

The effective dates of various provisions of the NPP Regulation vary, and the guidelines that are supposed to guide the implementation of the regulation have not yet been published. The guide is expected to be published soon, and an increase in the number of inspections in this area is expected in 2023.

Tagged with: Gün + Partners, Özge Atılgan Karakulak, Beste Turan, Dicle Doğan, Life Sciences & Healthcare,