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 glossary (O–P): UK and EU medicines, medical devices, pharmacovigilance, paediatrics and plant variety rights

Published by a LexisNexis Life Sciences expert

Practice notes

A–B | C–D | E–H | I–N | Q–V.

Officinal formula

Some medicinal products are exempt from the rule that an MA must be secured before marketing. An MA is unnecessary for medicines prepared within a pharmacy, in line with a pharmacopoeial Prescription, which are intended for direct supply to patients served by that pharmacy. This is referred to as the officinal formula.

Off-label

The deliberate use of an authorised medicinal product outside the conditions of its MA (for example, a different indication, an alternative dose, or in another patient population). For medical devices, use is off-label where the device is employed in a manner other than that set out by the manufacturer.

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