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

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

  • Pharmacovigilance
  • Development of pharmacovigilance in the EU
  • EU regulatory framework
  • UK regulatory framework
  • The EU regulatory network and the Pharmacovigilance Risk Assessment Committee (PRAC)
  • EudraVigilance
  • EU guidelines on good pharmacovigilance practices (GVPs)
  • GVP modules
  • Product-specific or population-specific considerations
  • Application of EU GVP in the UK
  • More...

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 holders (MAH), the European Medicines Agency (EMA), and national competent authorities (ie the medicines regulatory authorities in EU Member States) to operate a pharmacovigilance system. The medicines regulatory authority in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA).

The overall EU pharmacovigilance system operates through co-operation between the Member States, the EMA and the European Commission. The EMA co-ordinates the system and operates services and processes to support pharmacovigilance in the EU. The EMA pharmacovigilance system manual describes how the EMA performs, monitors and reports on its pharmacovigilance duties for human medicines.

The UK regulatory framework for pharmacovigilance has mainly originated from EU law. Many principles and requirements derived from EU law have been maintained in UK domestic law

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