Produced in partnership with Eveline Van Keymeulen and Jeanne Fabre of Allen and Overy

The following Life Sciences guidance note Produced in partnership with Eveline Van Keymeulen and Jeanne Fabre of Allen and Overy provides comprehensive and up to date legal information covering:

  • Pharmacovigilance
  • Development of pharmacovigilance in the EU
  • Regulatory framework
  • The EU regulatory network and the Pharmacovigilance Risk Assessment Committee (PRAC)
  • EudraVigilance
  • Establishing a pharmacovigilance system
  • Qualified person responsible for pharmacovigilance (QPPV)
  • Pharmacovigilance inspections
  • Pharmacovigilance audit
  • Risk management systems
  • 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.

Pharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product throughout their use in patients.

Before a medicinal product is authorised for use, information regarding its safety and efficacy is obtained from clinical trial.

However, it is essential that the safety of all medicinal products continues to be monitored throughout their use in patients because after authorisation they will typically be used in a larger number of patients, for a longer period of time and in combination with other medicinal products, meaning that adverse effects may occur that were not apparent during clinical trials.

EU law therefore requires marketing authorisation (MA) holders (MAHs), the European Medicines