Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Marketing Authorisation definition

What does Marketing Authorisation mean? Marketing authorisation is, in practice, the medicines regulator’s permission to place a medicinal product on the market. It specifies the authorised indications (medical conditions), patient population and dosage, and sets any conditions binding on the marketing authorisation holder (MAH). It is the legal basis for supply and promotion and underpins the Summary of Product Characteristics (SmPC), patient information leaflet and labelling. Use outside it is “off-label”. It is a statutory concept: in the UK under the Human Medicines Regulations 2012, and in Ireland under Directive 2001/83/EC and Regulation (EC) No 726/2004. In Great Britain, the MHRA grants national marketing...

Life sciences regulatory and IP glossary (Q–V): medicines, medical devices, pharmacovigilance, ATMPs, clinical trials, Specials, NHS pricing and access

Published by a LexisNexis Life Sciences expert

Practice notes

A–B | C–D | E–H | I–N | O–P.

Qualified person (QP)

The qualified person (QP) must confirm that every batch of medicinal products is manufactured and checked in line with UK or EU Member State law and in keeping with the marketing authorisation (MA) terms.

Qualified person for pharmacovigilance (QPPV)

A qualified person for pharmacovigilance (QPPV) is the individual who, by law, holds personal responsibility for the safety of a human medicinal product.

Rare disease

See: orphan medicinal product (OMP)...

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Web page updated on 21/05/2026

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