If your company is intending to market any pharmaceutical product in the European Economic Area (all the EU, Switzerland, Iceland, Lichtenstein or Norway), you’re going to need pharmacovigilance services of the very highest quality. Pharmacovigilance is subject to extremely stringent legislation throughout the Area and you’ll need ongoing pharmacovigilance work from an EU Qualified Person (QPPV). Since many small to medium sized companies of course don’t have QPPV on their staff team, this article explains why they are essential, their legal duties and what to look for when appointing one.
The legislation covering the whole of the European Economic Area (EEA) strictly states that you must use a Qualified Person for Pharmacovigilance (QPPV) – there is no leeway for using in-house no qualified persons instead. The QPPV takes responsibility for ensuring legal requirements are met in three key areas.
Firstly, they must establish the Market Pharmacovigilance institute Authorisation Holder’s Pharmacovigilance System and manage it on an ongoing basis. This involves all of the company’s activities which relate to the detection, assessment, understanding and communication of safety information, and all risk management work. Having established a system which meets the law, they also have an important role in safety profiles.
Secondly, it is always the QPPV who must take the legal responsibility to oversee the safety profiles for all of your companies products marketed within the EEA. This means, they are inevitably legally responsible for managing any safety concerns which emerge. This is not to say they would not of course, liaise with your staff, but again, this is not an aspect of pharmacovigilance work that can ultimately by handled by a non-qualified person in house. As well as safety profiles, they also have to be the person who is the key contact for regulatory Authorities.
In this respect, they are by law absolutely required to make themselves available to the regulatory Authorities 24 hours a day, 365 days of the year, without any exceptions. They will be the key contact for any pharmacovigilance inspections which a regulatory Authority deems necessary. This is where a problem sometimes for small to medium companies, in that they must be able to find a QPPV who is located within the EEA – and has sufficient pharmacovigilance services experience to be able to handle such contact with the highest degree of professionalism and competence.
In practice, this is going to mean you will need to appoint a QPPV who is “permanently and continuously at the disposal” of your company (the Marketing Authorisation Holder). However, this is not going to be enough to ensure your company is able to both meet the requirements and handle any challenges unless your chosen QPPV has senior level experience in every facet of pharmacovigilance. In addition, there may also need to be a deputy appointed to the QPPV, to ensure full compliance. Whilst small to medium companies may have excellent staff on board, they sometimes of course do not have a team member available who can step up to this role in terms of both qualifications and experience. The route companies typically take in this situation is to outsource to a well established pharmacovigilance services company whose staff can liaise with theirs to provide the necessary pharmacovigilance work to ensure compliance.