Poland is one of the fastest-growing EU markets in Central and Eastern Europe, offering significant opportunities for pharmaceutical, medical device, and biotech manufacturers with its expanding healthcare sector and access to the EU single market.
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL – Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych) is the national competent authority in Poland responsible for regulating medicines, medical devices, in vitro diagnostics, and biocidal products. As an EU Member State, Poland fully applies centralized procedures via EMA for medicines and MDR/IVDR for devices, with URPL handling national registrations, decentralized/mutual recognition procedures, clinical trials, pharmacovigilance, vigilance reporting, and local compliance requirements. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Poland’s EU-harmonized yet nationally administered framework, prepare compliant dossiers, secure efficient approvals, and achieve long-term success in this dynamic and high-potential EU market.
Get Poland Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Poland-specific adaptation, scientific/technical review, and quality assurance for URPL/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via URPL and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to URPL, ethics committee coordination, and regulatory support for clinical trials in Poland.
Polish QPPV/local contact person services, PSUR/PBRER submissions to URPL/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and URPL registration/oversight compliance in Poland.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per URPL and EU requirements.
Polish labelling review, Blue Box/EEA requirements, mock-ups, readability testing, and URPL approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with URPL and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), URPL scientific advice preparation, and up-to-date Polish/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Poland — from URPL/EMA submissions and MDR/IVDR compliance to pharmacovigilance, lifecycle management, and sustained EU market success.
Contact Our Poland Regulatory Experts