CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

• Phase I-III 8 000 PLN (approx. 2000 Euro)
• Bioequivalence trials 7 000 PLN (approx.. 1800 Euro)
• Phase IV 4 000 PLN (approx. 1000 Euro)
• Non-commercial trials: 2 000 PLN (approx. 500 Euro)
• Amendments: 1500 PLN (approx.350 Euro)

Waiver for academic (non-commercial) studies possible

Reduced fees are charged

Official guidance on required fees

Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491) defines applicable fees.
Current fees are also provided in English on the URPL website in section: Fees.

Applicable national legal framework/ Reference

Art 37m of the Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)
Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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