Based on the Exception and Modifications to the EU guidance and the guidance on Pharmacovigilance Procedures, it is my understanding/ assumption that all UK (including Northern Ireland) ICSR (serious and non-serious) and serious ICSRs from other countries should be reported to the MHRA for CAP products that are available for use in Northern Ireland even if there are not yet approved in GB.
Could the above understanding be confirmed by other members ? Many thanks !
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