Marketing authorisations in the EU—regulatory procedures for approval of medicinal products

Copyright © 2025 LexisNexis
Published by a LexisNexis Life Sciences expert
Practice notes

Marketing authorisations in the EU—regulatory procedures for approval of medicinal products

Copyright © 2025 LexisNexis

Published by a LexisNexis Life Sciences expert

Practice notes
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Jurisdiction(s):
United Kingdom
Key definition:
Marketing Authorisation definition
What does Marketing Authorisation mean?

The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.

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