EU QPPV and local QPPV/ named safety contact
Within the EU, each Marketing Authorisation Holder (MAH) of human, veterinary or herbal medicinal products should ensure to have at his disposal a single point of contact, with a deputy, who is available 24/7 to act as the Qualified Person for Pharmacovigilance (QPPV). The QPPV must be experienced in all aspects of pharmacovigilance and must reside and work within the European Economic Area (EEA).
The good pharmacovigilance system requires fluent communication between stakeholders, good interaction between processes, robust Quality Management System with record management, and an efficient, proactive overview of experienced QPPV. With Medfiles experienced QPPVs and deputy QPPVs we can ensure that your PV system fulfil the EU Directive 2001/83/EC requirements for Pharmacovigilance system. In addition to QPPV services, Medfiles is able to provide all or some of pharmacovigilance activities according to your needs.
Our QPPVs have a long experience as safety experts with the additional training on quality assurance, data
integrity and data validation.
Local QPPV/ Local safety contact
While the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation. Medfiles can provide a qualified and experienced local responsible persons for pharmacovigilance in applicable EU-territories through its Regulatory Affairs and Pharmacovigilance partners qualified and audited by Medfiles vendor management operations.
Medfiles can also assist in communication with the national competent authorities and give advice on local pharmacovigilance requirements. With the continuous monitoring of local regulations Medfiles has the up to date knowledge on current legislation on coming changes.
Medfiles can assist you with safety issues relating Brexit.