UK – Guidance on MAH and QPPV location from 1 January 2021

The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV) after the end of the transition period.

The MAH must have permanently and continuously at its disposal a QPPV who is responsible for the establishment and maintenance of the pharmacovigilance system for UK nationally authorised products.

The QPPV for UK nationally authorised products (including those that cover Northern Ireland, Great Britain or the whole of the UK) can reside and operate anywhere in the UK or the EU/EEA. Where the QPPV does not reside and operate in the UK, there will be a need for a national contact person for pharmacovigilance who resides and operates in the UK.

A UK located QPPV will not be accepted in EU Member states…