Reply To: ICSR reporting to MHRA post Brexit

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#42291

Dear Member

Thank you for your query.

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.

Please follow the link below:

Modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders (publishing.service.gov.uk)

Kind regards

PIPA