CAAmendment object

Authorisation mandatory for

Any substantial amendments

Timeline for approval of SA (max nr days)

30
From date of submission
One clock stop possible if complementary information requested
Positive EC vote is prerequisite for CA approval

Guidance on submission of SA

Details on types and definitions of substantial amendments as well as on the application procedure, along with the required documentation, are provided in Art 13-22 of the Rulebook Application 2011.

Applicable national legal framework/ Reference

Art 85 Law on MP & MD 2010
Art 13-23 Rulebook Application 2011

Additional Information

Procedure: Local EC approval must be obtained prior to CA submission and approval.
NB! No prior EC opinion is required, if the substantial amendment is related to the quality of the investigational medicine and/or changes to the bearer of the authorization for the implementation of clinical trials for the medicine. (pursuant to Art 22 Rulebook Application 2011).

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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