An introduction to the regulation of medicinal products

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • An introduction to the regulation of medicinal products
  • EU and UK legal framework governing medicinal products
  • EU legal framework
  • UK legal framework
  • EU and UK key regulatory bodies
  • European Medicines Agency (EMA)
  • Committee on Medicinal Products for Human Use (CHMP)
  • European Commission
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • National Institute for Health and Care Excellence (NICE)
  • More...

An introduction to the regulation of medicinal products

EU and UK legal framework governing medicinal products

A complex array of requirements and guidelines developed at EU, EU Member State and UK levels 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)

  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. advanced therapy medicinal products (ATMPs)

  13. 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 considerable differences among EU Member States in their approach to implementation and enforcement.

The key laws and regulations governing medicinal products are:

  1. Directive 2001/83/EC, the Pharmaceutical Code which establishes the regulatory framework for the sale, production, labelling, classification, distribution and advertising of medicinal products for human use

  2. Regulation (EC) 726/2004, the EMA Regulation establishes the EU medicines regulator, the European Medicines Agency (EMA) and lays down

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