Marketing Authorisation Holder (MAH) and Qualified Person for Pharmacovigilance (QPPV) location
Establishment of the MAH
The MAH for a UK MA must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA.
An exception to this requirement applies in the case of an application for a Great Britain MA made through the unfettered access route in which the applicant seeks recognition in Great Britain of a MA approved in Northern Ireland.
One of the conditions for eligibility for that route is that the MAH must be established in Northern Ireland.
A UK located MAH will not be accepted in EU Member States.
Location of QPPV
The QPPV for UK nationally authorised products (including those that cover Northern Ireland, Great Britain (England, Scotland and Wales) 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* (details below) for pharmacovigilance who resides and operates in the UK**.
*There will be a temporary exemption in place which allows you 12 months from 1 January 2021 to appoint a national contact person for pharmacovigilance that resides and operates in the UK.
** This is provided for by regulation 182 of the Human Medicines Regulations 2012 (as amended) (HMR).
A UK located QPPV will not be accepted in EU Member states.
See guidance for more detail on handling changes to QPPV and pharmacovigilance system master files (PSMF).
National contact person for PV
If you choose to establish a QPPV who resides and operates in the EU, you must nominate a national contact person for PV who resides and operates in the UK and reports to the QPPV.
This individual should have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorized products.
The individual should be able to facilitate responses to PV queries raised by the MHRA, including via inspections.
Once the national contact person for PV has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal.
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