Medicines & Pharmaceutical Product Authorization in Poland
If you're trading medicines, producing supplements, importing medical products, or selling cosmetics with active substances, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) governs your authorization in Poland — operating within the European medicines network alongside the European Medicines Agency (EMA).
BIZ TRP confirms exactly what your business needs before you commit to anything.
At a glance
- Authority
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
- Application validation
- Within 10 days for reporting Member State
- Scientific evaluation
- Standard EU evaluation timeline
- EU network
- Coordinated with the European Medicines Agency (EMA)
Who needs this
- A registered legal entity for the pharmaceutical business Required
- Marketing authorization for each medicinal product Required
- Compliance with EU pharmaceutical regulations Required
- Pharmacovigilance reporting procedures Required
Registration process
Determine your authorization route
National, mutual recognition, decentralized, or centralized (EU-wide) — depends on your product and target markets.
Submit your application
Complete technical and clinical documentation for the product.
Validation
Within 10 days for reporting Member State — the authority checks the application is complete.
Scientific evaluation
Standard EU evaluation timeline, excluding any clock-stops while you respond to questions.
Decision and ongoing compliance
Once authorized, maintain pharmacovigilance reporting and respond to any post-market requirements.
What it costs
Government fees
- State fees
- Ask us for the current figure — varies significantly by product type and authorization route
BIZ TRP fees
- Route confirmation & application support
- Ask us for a quote — from €120/hour
Why work with BIZ TRP
Choosing the wrong authorization route — national when you needed EU-wide, or vice versa — means redoing months of scientific evaluation. This is one of the highest-stakes regulatory decisions a pharmaceutical business makes.
- We confirm the right authorization route. National, mutual recognition, decentralized, or centralized — matched to your actual product and markets.
- We prepare your application documentation. Technical and clinical documentation, ready for submission.
- We support ongoing pharmacovigilance compliance. So post-market obligations don't catch you off guard.
Common questions
What's the difference between national and centralized authorization?
National authorization covers a single country; centralized authorization through the EMA covers the whole EU at once. Which route fits depends on your product and target markets — we confirm this for your specific case.
Does this cover cosmetics too?
Cosmetics with active pharmaceutical substances can fall under this regulation — plain cosmetics generally don't. We confirm which applies to your specific product.
Need help with Medicines & Pharmaceutical Products in Poland?
BIZ TRP confirms the right authorization route for your medicinal product before you commit to a months-long evaluation process.
Talk to us about Medicines & Pharmaceutical Products Email us