EU Pharma Told To Appoint 'Regulatory Contact' In EudraVigilance to comply with QPPV Rules
This article was originally published in SRA
Executive Summary
The European Medicines Agency is asking all drug marketing authorization holders in the EU to appoint a "regulatory contact point" within the EudraVigilance registration database who will be authorized to communicate with the EMA on their behalf. These communications may include non-procedural issues such as requests to change their EU qualified person for pharmacovigilance (EU QPPV)1.