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There is sometimes a bit of misunderstanding about what the Qualified Person for Pharmacovigilance (QPPV or QP) is and does. In this post,I will attempt to clarify the situation.


The Qualified Person was initially defined in Directive 2001/83/EC.

“As part of the pharmacovigilance system, the marketing authorisation holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (QPPV)” Article 104

It was later expanded and defined in Volume 9A which has since been further defined by the Good PV Modules modules 1 and 2.


Here, then, is a basic summary of the QP requirements.

There must be a QP and a deputy in place when any Marketing Authorization Holder (MAH) has approval to market a product in the EU/EEA.  In fact, it is necessary to specify the QP in the actual submission dossier of the MA to the EMA.  Thus the QP must be identified at the time of submission and a pharmacovigilance (PV) system must be in place at submission even if it is not yet being used.

If a company does not yet have an MA or a submission and is just doing clinical trials there is no requirement for a QPPV.  This is a point that is not always understood.

The QP and deputy must be permanently and continuously available and reside in the EU/EEA (note that this does not include Switzerland).  The QP should be a senior person reporting at a high level in the management structure of the MAH with a clear reporting structure though this is not always the case.

The QP should have a formal written contract and there should be an SOP clearly defining the QP’s roles, functions and responsibilities.  These responsibilities include the oversight, structure, performance and maintenance of the PV system in the MAH.  This includes:

The MAH (the company) in turn has responsibilities that it must fulfill:

The person who is the QPPV must be:

The QPPV may delegate tasks.  If so, this should be done in writing and an oversight system for the out-sourced function be put in place.  The QPPV (and MAH) still maintains responsibility for delegated tasks.

The EMA and MHRA (in a 2010 presentation by one of the Expert Inspectors) have made clear, however, that they will look very closely at delegated or out-sourced QPPVs.  Broadly speaking, the CAs will not look kindly on a person (e.g. in a CRO) who functions as the QPPV for more than two or three companies at any time.  It is felt that the job is so large, even in smaller or generic companies, that no one can handle all the responsibilities for more than 2 or 3 companies at a time. The MAH out-sourcing the QPPV must ensure that:

Finally, some countries in the EU have established national QPs whose jurisdiction is only in that country.  This is in addition to the EU/EEA level QPPV.  Sometimes these national QPs are out-sourced and sometimes they are company employees.  They may or may not directly report to the EU level QPPV.  In any case, clear SOPs and responsibilities must be in place in written SOPs that define the system(s).  The company/MAH must verify in each member state what local requirements are necessary such as a QP in order to market a product.



The QPPV is a major responsibility that all MAH’s in the EU must fulfill and fulfill well.  This is not a routine job but one that must be done well.  Although safety issues may arise less in smaller or generic companies, the potential for a safety issue (or safety crisis) always exists and it is at these times that the QP becomes an important player.  Similarly, during government inspections the QPPV will also play a major role.  Thus the QP should be sufficiently senior, have authority, responsibility and the appropriate “power”.  Although not necessarily a physician, it is wise that the QP have some level of medical training and experience.  It is an important job and should be so treated.

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