CRED ERP 25

responsibilities and provide all required information • Consent must be obtained for all three modules containing the pharmaceutical, pre-clinical and clinical data • The authorisation of the informed consent application should follow the same authorisation route as the initial authorisation. Therefore, a national, MRP or DCP informed consent application cannot refer to a centralised approved medicinal product • Module 3 does not have to be provided in this case • If consent is subsequently withdrawn, this does not affect validity of application • Contractual arrangements between parties should define what will happen if consent is withdrawn

See: CMDh document: CMDv BPG-12 Informed consent 19.06.13 EMA-CMDv-377880-2010

CMDh document: Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures