On 25 April 2014, the European Medicines Agency (“EMA”) updated its guidelines on Good Pharmacovigilance Practices (“GVP Guidelines”). The update includes the first revisions of Module V on risk management systems and Module XVI on risk minimisation measures of the GVP Guidelines. Furthermore, the definitions provided in Annex I of the GVP Guidelines have been updated to reflect the amendments to Module V and Module XVI of the GVP Guidelines.
Module V of the GVP Guidelines on risk management systems is revised to reflect the revisions to the EMA guidance on format of the risk management plan in the EU, particularly Part V on risk minimisation measures. The Module is also updated to reflect the requirement that a submission of a new or updated risk management plan outside another regulatory procedure constitutes a type II variation. This requirement was provided in the amendments to the Guidelines on the details of the various categories of variations (“Variations Guidelines”). For more information on the amendments to the Variations Guidelines, please see our earlier update.
Furthermore, the definition of Risk Minimisation Measures has been updated in Module XVI on risk minimisation measures in accordance with the amended definition of Risk Minimisation Measure in Module V on risk management systems.
Finally, Annex I of the GVP Guidelines on definitions was revised to replicate the updated definitions of Missing Information and Risk Minimisation Activity/Measures provided in Module V on risk management systems.