The published guidance states that after the end of the transition period Qualified Person responsible for Pharmacovigilance (QPPV) for UK nationally authorised products can reside and operate anywhere in the UK or the EU/EEA. Where they don’t reside and operate in the UK, there will be a need for a national contact person for PV who resides and operates in the UK. A UK located QPPV will not be accepted in EU Member States.
Marketing Authorisation Holders (MAH) must be established in the UK or the EU/EEA. An exception to this requirement applies where an application for a GB MA is made through the unfettered access route in which the applicant seeks recognition in GB of a MA approved in Northern Ireland (NI). In this case the MAH must be established in NI.
A UK MHA will not be accepted in EU Member States.
Brexit – MHA and QPPV location: