CAAmendment object
Any substantial amendments
Sponsor
Yes
The standard form for submission of substantial amendments (Form 2) to be used is available (in Serbian and Cyrillic script only) on the ALIMS website in section Regulativa » Humani Lekovi » Obrasci (Obrasci vezani za klinička ispitivanja lekova).
30
From date of submission
One clock stop possible if complementary information requested
Positive EC vote is prerequisite for CA approval
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.
Art 85 Law on MP & MD 2010
Art 13-23 of Rulebook Application 2011
NB! Positive vote of the EC is prerequisite for CA approval: 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