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Pharmacovigilance System Outsourcing

The Global Drug Safety database (ARISg™)

A 21CFR compliant, fully validated safety database is an essential part of Good Pharmacovigilance Practice. An accurate and accessible database allows rapid assessment of data for signal detection, aggregate report production and statutory electronic reporting of cases to the regulatory authorities. PrimeVigilance operate a fully validated system with ARISg™ which is one of the leading industry standard pharmacovigilance databases.

Safety Data Exchange Agreements (SDEA)

Safety Data Exchange Agreements are legal written contracts ensuring that all safety data regarding a licensed product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations to aggregate safety data and to submit safety reports in a timely manner.

Pharmacovigilance System Master File (PSMF)

EU Directive 2010/84/EU (amending 2001/83/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA. The PSMF is a modular document containing all of the details of the pharmacovigilance system for the product. It must be made available to a Competent Authority on request, within 7 calendar days.

Provision of EEA Qualified Person for Pharmacovigilance (EEA QPPV)

Your medicinal products cannot be marketed within the European Economic Area (EEA) without a Qualified Person for Pharmacovigilance (QPPV) that is personally responsible in law for the fulfilment of key functions...

Provision of a National Person Responsible for Pharmacovigilance (NPRP)

PrimeVigilance offers an extensive network of “Local QPPVS” – more accurately National Persons Responsible for Pharmacovigilance (NPRP) in key European Economic Area (EEA) countries where the provision of an NPRP or Contact Person is mandatory if a product receives marketing authorisation.