Introduction To Expected And Unexpected Pharmacovigilance ‘Events’

Products containing novel substances reserved for the treating of major illnesses should be subject to the centralized process. It’s a necessity for the appointing of a Rapporteur, and this may be the regulatory agency of one Member State and a Co-Rapporteur. Those 2 rapporteur states are then charged with directing safety assessment and monitoring for the product on and after presentation to the market). It does not need to be said that either the in-house pharmacovigilance team in the candidates company (or a high quality external team elected to provide pharmacovigilance services ) should be critical to guide the applicant smoothly through this stage. In brief, in this context, the process means the marketing authorisation granted by one Member of the EU is duly recognized and copied by all remaining Member States. Consequently, the other EU Members accept the first evaluation of the product itself. Often, a Member State can decide to raise challenges and meantime fail to recognize the first marketing authorisation. In such cases, the problem can be referred to the EMEA for debate among the parties concerned. Should that process fail, binding settlement will be imposed.

Again, the applicant’s Pharmacovigilance institute pharmacovigilance firms should invariably be on hand to give correct direction and recommendation for successful completion of any application.

This process can apply in situations where no marketing authorisation has been granted in any of the countries of the EU till now. Matching dossiers will be submitted to regulators in all EU countries in which a marketing authorisation will be required. The candidate is able to select the “Reference Member State” and formulates an initial assessment report inside 120 days.