Jurisdiction(s):
United Kingdom

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...

EU/EEA medicines marketing authorisations: centralised, mutual recognition, decentralised and national procedures; assessment timelines and decision-making; accelerated assessment and PRIME; transfers and duplicates; and 2023–2025 pharmaceutical law reforms

Published by a LexisNexis Life Sciences expert

Practice notes

No Medicinal Product can be marketed until it has obtained approval known as a Marketing Authorisation (MA). An MA spECifies the authorised indications, the patient population and the dosage, together with any conditions placed on the MA holder (MAH). The approval framework is regulated by Directive 2001/83/EC on the Community Code relating to medicinal products for human use (the Pharmaceutical Code). There are several routes to secure an MA for medicinal products:

EU centralised procedure (CP), with medicines approved via the CP often termed centrally authorised products (CAPs)
Mutual recognition procedure (MRP)
Decentralised procedure (DCP)
National procedure

The appropriate route is determined by the product’s nature, therapeutic area and the type of licence required (ie where the product is to be sold and whether licences already exist in other EU/EEA Member States). There are also several different legal bases on which an MA application can be made...

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Web page updated on 21/05/2026

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