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Qualified Person responsible for Pharmacovigilance (QPPV): UK requirements regarding legal presence

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 both Category 1 and Category 2 products as well as PLNI licenses and PLGBs) ) 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 by EU Member states except where the MAH did not have at its disposal a QPPV located in the EU prior to April 2022.

See further guidance on the QPPV for UK authorised products and the national contact person.

Establishment of the Marketing Authorisation Holder (MAH)

The marketing authorisation holder for a UK marketing authorisation (MAH) must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. A UK marketing authorisation is one that is granted by the UK Licensing Authority to permit the sale or supply of a product in Great Britain, Northern Ireland or in both territories.

An exception to this requirement applies in the case of an application for a Great Britain marketing authorisation made through the unfettered access route in which the applicant seeks recognition in Great Britain of a Marketing Authorisation (MA) approved in Northern Ireland.

One of the conditions for eligibility for that route is that the MAH must be established in Northern Ireland.

In an EU decentralised procedure or mutual recognition procedure, a UK located MAH will be accepted by the Reference Member State for the UK(NI) marketing authorisation only not for the marketing authorisations issued by EU Member States.