Do refer to the Guideline on good pharmacovigilance practices (GVP)
Module VI – Collection, management and submission of reports of suspected
adverse reactions to medicinal products (Rev 2), section VI.C.18.104.22.168. Follow-up information, sub-section a. Significant information, in which both National Competent Authority and Marketing Authorisation Holder must follow ICSRs. "Medical judgement should therefore be applied for the identification of significant new information requiring to be submitted as follow-up ICSR." Reviews by Authorities and MAH are complementary and expected.