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