All applications for marketing authorisation in the EU must include a detailed and complex Risk Management Plan (RMP). In addition, renewals for older or generic products require an RMP.
A new or updated Risk Management Plan in Pharmacovigilance may be required where there are certain variations to the marketing authorization. This requirement depends on the nature of the variation and may not be necessary in all circumstances. Our expert medical writers and Pharmacovigilance risk benefit specialists can advise both on the need for an abbreviated RMP and on its content. PrimeVigilance can help our clients determine important identified and potential risks for both detailed and abbreviated risk management plans.
PrimeVigilance, has extensive experience in writing RMPs, assessing risk benefit analysis, RMP maintenance, and in line with GVP Module V can advise or perform analysis of the effectiveness of the risk minimisation activities.