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Pharmacovigilance modules issued for consultation


The European Medicines Agency (EMA) has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.

Each of the seven modules released covers one of the seven following major processes in the safety monitoring of medicines.

  • Module I: Pharmacovigilance systems and their quality systems
  • Module II: Pharmacovigilance systems master files
  • Module V: Risk management systems
  • Module VI: Management and reporting of adverse reactions to medicinal products
  • Module VII: Periodic safety update reports
  • Module VIII: Post-authorisation safety studies
  • Module IX: Signal management.

GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU).

They apply to marketing-authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients by strengthening pharmacovigilance across the EU.

They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

The release of these modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from July 2012.

Each module was developed by a team consisting of experts from the Agency and from EU Member States.

The Agency is seeking comments on the practical implementation of the legislation as outlined in these modules. The underlying legal requirements cannot be altered through this consultation process.

The Agency intends to finalise and publish these modules by July 2012, after comments from stakeholders have been taken into account.

European Medicines Agency

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