Named Patient Programs ("NPP") is one of the exceptional pharmaceutical importation regimes for products that are not authorized or authorized but unavailable in the Turkish market for various reasons.
In cases where a product does not have marketing authorization in Türkiye or has marketing authorization but cannot be found on the market, and patients need the product in question, it is possible to procure the pharmaceutical via this method upon the request of a physician. The program is regulated by the Guidelines published by the Agency.
There were numerous allegations in the news that the drugs supplied from abroad and used in the treatment of cancer were only products containing painkillers and that the products were counterfeit. The Agency and the SSI made press statements on this issue, mentioning that criminal complaints had been filed against those involved in supplying counterfeit products. As a result of these developments, the Regulation on the Supply of Medicines from Abroad ("NPP Regulation") was published on February 3, 2023 and the roles of stakeholders in the procurement process have been defined more clearly:
- Foreign institutions and organizations that supply medicines from abroad have been identified as Foreign Supply Sources, and having a Representative in Türkiye has become mandatory.
- The qualifications of the Foreign Supply Sources and where it should supply the product, if it is not a manufacturer, are regulated.
- It is stipulated that the Turkish Pharmacists Association, the SSI, and the public institutions which are deemed appropriate by the Ministry that supply products from abroad ("Foreign Drug Suppliers") shall distribute the products by the legislation to which pharmaceutical warehouses are subject.
In addition, it has been provided that the products procured through these means must be registered on the Drug Monitoring System ("ITS"), just as the authorized medicines, and will be tracked through this system and a QR code must be applied on the products procured.
In line with the new rules stipulated in the Regulation, the Guidelines on the Supply of Pharmaceuticals from Abroad ("Guidelines"), which indicates the guiding provisions regarding the implementation of the Regulation, has been updated.
According to the Guidelines:
- The QR code process, which Foreign Drug Suppliers must perform, can be performed by the Foreign Supply Sources in the customs-free zone.
- The Representative can meet the financial obligation regarding ITS notifications and QR coding transactions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.