Can anybody confirm if organisations are required to submit (via ICSR Portal or Gateway) follow up reports to MHRA for ICSR cases we have already informed MHRA about? It is not clear from reading the MHRA guidance on pharmacovigilance as to whether this is a requirement or not, however I can see that this is done by some other organisations.
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Please note that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as
As per the guidance titled: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority, paragraphs VI.C.2.2. Responsibilities of the marketing authorisation holder in the EU and VI. Appendix 1 Process for follow-up of ICSRs, follow up reports are required by the licensing authority.
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