The Named Patient Programs (NPP) are import regimes that allow medicines not authorized in Türkiye or authorized but unavailable for various reasons to be imported from abroad upon request by a physician.
Following publication of the Regulation on the Importation of Medicines from Abroad ("NPP Regulation") published on 3 February 2023, the roles of stakeholders in the relevant process have been clarified. According to this NPP Regulation, institutions and organisations located abroad have been defined as "Foreign Drug Supply Sources," and it has become mandatory for them to have a representative in Türkiye. Furthermore, institutions approved by the Turkish Pharmacists' Association, SSI, and the Ministry of Health have been designated as "Foreign Drug Suppliers," and it has been stipulated that pharmaceutical warehouses must distribute medicines in compliance with the relevant regulations.
Additionally, pharmaceuticals obtained through these channels must be recorded in the Drug Tracking System (“İTS”), just as authorised pharmaceutical products and tracked through this system with a designated QR code.
In addition to this Regulation, the Guidelines on the Importation of Medicines from Abroad has also been updated. According to the updated Guidelines, the QR code process performed by foreign drug suppliers may also be carried out by the foreign drug supply source in the customs-free zones. Moreover, it has been stated that the financial obligations related to İTS notifications and QR code processes can be covered by the supplier's representative. This is an important development aimed at increasing transparency and traceability in the pharmaceutical product supply process.
The 12th Development Plan and the 2025 Presidential Annual Program, which hold significant place in Türkiye's healthcare policies, aim to include cost-effective options for pharmaceutical importation in the payment lists. This regulation is designed to contribute to the more efficient management of healthcare expenditures and to expedite patient treatment. However, the primary goal of the exceptional import regime for the importation of drugs from abroad is to ensure the availability of drugs for patients that are not authorised in Türkiye or are not available on the market.
In this context, the effective use of the named patient program mechanism is crucial for both enabling patients to access treatment more quickly and supporting the sustainability of the healthcare system. The inclusion of cost-effective pharmaceuticals in the payment lists can especially have a positive impact on the healthcare budget. However, another important issue to consider in the supply of such pharmaceuticals is ensuring that the imported products are safe for use and are of high quality.
Furthermore, compliance with the regulations stated in the legislation will assist in preventing potential security and quality related problems that may arise in the importation of pharmaceuticals. For the effective operation of Türkiye's healthcare system, these regulations must be carefully adhered to by both manufacturing companies and relevant public institutions. These measures in the healthcare system will ensure that patients gain faster and safer access to the pharmaceutical products they need, while also being effective in preventing the sale of counterfeit drugs.
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