Yes, all Marketing Authorisation Holders (MAH’s) within the European (EU) Economic Area (EEA) are required to apply the relevant EU Pharmacovigilance (PV) legislation – this particularly applies to products sold in the EU and globally. The EU legislation requires that a MAH should have an appropriate system of PV in place, which is used by an organisation to fulfil its legal tasks and responsibilities in relation to PV and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
The reality of PV is that multi-national companies operate in a global environment and whilst national regulation must be considered both within the EU and outside of the EU, it is expected that EU GVP regulations apply across geographical boundaries where there has been marketing authorization within the EEA. It should be remembered that where an MAH has delegated responsibilities to another party, the legal accountability still remains with that MAH (for example, ensure your contract specifies the timelines for receiving ICSRs/follow-up info and even invalid cases [e.g. drug-event only] with sufficient time to process the data before you as MAH are required to submit the serious/non-serious ICSRs to European and other global Health Authorities, or allows your company to have included the data into the analyses for PSUR/PBRER updates; or ensure that your contract includes periodic local literature searches, even though locally that may not be required – these are, of course, just 2 examples). Please note that recently inspections of EU Competent Authorities have more rigorously reviewed global distribution contracts for PV sections in compliance with EU requirements.