An introduction to the regulation of medicinal products
An introduction to the regulation of medicinal products

The following Life Sciences guidance 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 and UK key regulatory bodies
  • Definition of medicinal product
  • Marketing authorisation and regulatory procedures for approval of medicinal products
  • Regulation of biosimilars
  • Regulatory data protection
  • Clinical trials
  • Advertising and promotion of medicinal products
  • Falsified medicinal products
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

EU and UK legal framework governing medicinal products

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

  1. clinical testing (ie clinical trials)

  2. placing on the market (ie marketing authorisations (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)

  12. advanced therapy medicinal products (ATMPs)

  13. unlicensed medicines and off-label