CAAmendment object
Authorisation mandatory for
All clinical investigations requiring authorisation by CA
Responsible for submission of SA
Sponsor
Standard notification form available
Yes
Standard notification form
A Standard Application From for the Submission of Amendments (Wzór wniosku o wydanie pozwolenia na wprowadzenie zmian w badaniu klinicznym) to the CA and the EC is provided on the CA website.
The application form is also provided in Annex 2 (Załącznik Nr.2) of Health Minister Order 15 Nov 2010.
Guidance on submission of SA available
Yes
Guidance on submission of SA
The application documentation for submission of amendments is specified in Art 44(3) Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl).
Applicable national legal framework/ Reference
Art 44 Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl)
Annex 2 (Załącznik Nr.2) of Health Minister Order 15 Nov 2010
Additional Information
NB! A positive opinion of the competent EC is a prerequisite for application to the CA.
