CAAmendment object

Authorisation mandatory for

All clinical investigations requiring authorisation by CA

Responsible for submission of SA

Sponsor
Investigator

Standard notification form available

Yes

Standard notification form

Available in Polish: "Wzór wniosku o wydanie pozwolenia na wprowadzenie zmian w badaniu klinicznym"

Timeline for approval of SA (max nr days)

35
By silent (implicit) approval

Guidance on submission of SA available

Yes

Guidance on submission of SA

The application process is described in detail in a regulation issued by the Minister of Health (Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491)).
This document includes a standard application form for the submission of amendments provided in Annex 2. This template is also available for download on the URPL website (pl) in section: Produkty lecznicze » Badania kliniczne » Formularze.

National legal framework in place

Yes

Applicable national legal framework/ Reference

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

Additional Information

Amendments to be authorized: Any amendments to the clinical trial protocol or to the investigational medicinal product, being substantial and likely to have an impact on the safety of the clinical trial subjects.

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