Poland

The primary regulatory authority in Poland is the URPL, which operates under the supervision of the Ministry of Health and is responsible for the registration and post-market surveillance of medicinal products, medical devices, in vitro diagnostics, and biocidal products. The main governing legislation includes the Pharmaceutical Law Act of 2001 (as amended), the Medical Devices Act of 2010 (now transitioning to align with EU MDR 2017/745 and IVDR 2017/746), and a range of subordinate regulations implementing EU directives and regulations into Polish law. Poland, as an EU member state, participates fully in the European Medicines Agency (EMA) centralized procedure for medicinal products, as well as the Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP). Products approved through the EMA centralized route receive automatic market authorization valid across all EU member states including Poland, while nationally registered products follow URPL review procedures directly.

For pharmaceutical submissions, Poland accepts dossiers prepared in the Common Technical Document (CTD) format in accordance with ICH guidelines, consistent with EU requirements. A local representative or marketing authorization holder established within the EU/EEA is mandatory for all product registrations. Medical devices must comply with EU MDR and IVDR requirements, including CE marking, and must be registered in the European EUDAMED database as it becomes operational. Poland has been actively harmonizing its national regulatory framework with evolving EU legislation, with recent reforms focusing on strengthening post-market surveillance, pharmacovigilance reporting obligations, and the digital submission of registration dossiers through the e-CTD portal. The URPL also participates in joint scientific consultations and reliance frameworks coordinated by the European regulatory network.

Public procurement of health products in Poland is centrally coordinated through the Ministry of Health, which sets reimbursement policy and oversees the national health insurance fund, the Narodowy Fundusz Zdrowia (NFZ, National Health Fund). The NFZ is the dominant payer for publicly reimbursed medicines, medical devices, and healthcare services, operating through regional branches that contract with hospitals, clinics, and pharmacies. Reimbursement decisions for pharmaceuticals are governed by the Reimbursement Act of 2011, which requires manufacturers to submit health technology assessment (HTA) dossiers to the Agency for Health Technology Assessment and Tariff System (AOTMiT) before inclusion on the national reimbursement list. Procurement of medical devices and diagnostics for public hospitals is conducted under the Public Procurement Law (Prawo Zamowien Publicznych), which implements EU public procurement directives and mandates competitive tendering for contracts above defined thresholds. Centralized hospital tenders are increasingly coordinated through purchasing groups or regional hospital networks to leverage economies of scale.

The private healthcare sector in Poland is growing rapidly, encompassing private hospitals, diagnostic laboratories, outpatient clinics, and pharmacy chains, and represents an increasingly important commercial channel for medical devices, diagnostics, and digital health solutions. International donor funding and multilateral procurement channels such as UNICEF, the Global Fund, or USAID play a minimal role in Poland given its upper-middle to high-income status and EU membership, though some cross-border EU-funded health projects and Horizon Europe research initiatives do influence procurement and innovation adoption. There are no formal local manufacturing preference policies mandated by law; however, EU public procurement rules permit contracting authorities to incorporate social and environmental criteria, and there is growing political interest in supply chain resilience that may favor domestically or EU-produced health products in future tender specifications. Digital health solutions are subject to additional evaluation requirements under NFZ reimbursement pathways, with AOTMiT developing dedicated HTA methodologies for digital therapeutics and eHealth technologies.