Introduction to the regulation of medicinal products—EU

Copyright © 2025 LexisNexis
Published by a LexisNexis EU Law expert
Practice notes

Introduction to the regulation of medicinal products—EU

Copyright © 2025 LexisNexis

Published by a LexisNexis EU Law expert

Practice notes
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EU legal framework governing medicinal products

A complex array of requirements and guidelines developed at EU and EU Member State national level govern the following aspects of medicinal products:

  1. •

    clinical testing (ie clinical trials)

  2. •

    placing on the market (ie marketing authorisation (MA) and regulatory procedure for approval of medicinal products and variations of those licensing MAs)

  3. •

    protection of the pre-clinical and clinical data developed for the purposes of obtaining an MA (ie regulatory data protection)

  4. •

    manufacture and importation

  5. •

    labelling and package leaflet

  6. •

    advertising and promotion

  7. •

    wholesale distribution and brokering

  8. •

    pharmacovigilance

  9. •

    pricing and reimbursement

  10. •

    falsified medicines

  11. •

    medicines for rare diseases (ie orphan medicinal products (OMPs))

  12. •

    paediatric medicines

  13. •

    advanced therapy medicinal products (ATMPs)

  14. •

    unlicensed medicines and off-label use of authorised medicines

EU legal framework

There has been a rapid expansion of law on these subjects at the EU level, with increased harmonisation in many areas. EU Member State requirements and guidelines still, however, remain essential parts of the EU regulatory picture. There are

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Jurisdiction(s):
European Union

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