May 30, 2024
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the applicant’s Pharmacovigilance system is part of the MAA and that way the MAH also proofs that it has at its disposal a Qualified Person Responsible for Pharmacovigilance (QPPV). Already here, it is evident that the QPPV is central to this system.
The requirements and responsibilities of an EU QPPV are laid down in EU legislation article 23 of regulation (EC) No 726/2004 and article 104 of Directive 2001/83/EC as amended by new PV Regulation /EU) No 1235/2010 and Directive 2010/84/EU. The QPPV is responsible for all aspects of PV for the products with Marketing Authorisation (MA) within the European Economic Area (EEA) and Northern Ireland and needs to reside in the EU/EEA.
For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the MAH must have permanently and continuously at its disposal a UK QPPV who is responsible for the establishment and maintenance of the UK pharmacovigilance system. The UK also accepts an EU QPPV to serve as the UK QPPV. In the situation where the UK QPPV does not reside in the UK, a UK LPPV is required..
The QPPV can be MAH's own employee or a contract employee, as long as QPPV is continuously at the disposal of MAH.
Watch out webinar: How to Setup an Effective PV System in the UK and EU/EEA
The main responsibilities of the QPPV are the establishment and maintenance of the marketing authorization holders PV System and to have overview on the safety profile of the medicinal product. Grouped in these two categories legislation lists much more and detailed responsibilities which include but is not limited to the below:
PV System related responsibilities |
Safety Product Profile related responsibilities |
---|---|
Authority to influence the performance of the quality system and the PV activities |
Overview on medicinal product safety profile and emerging safety concerns |
Promote, maintain and improve compliance |
Awareness of the marketing authorization s commitments related to the safety of the product |
Access to the PSMF |
Awareness of Risk Minimisation Measures |
Be in a position to verify information within the PSMF |
Authority over the content of risk management plans |
Receive schedules of PV audits and can trigger such audits |
Sign-off of protocols of post-authorisation safety studies |
Receive outcome of regular reviews of the MAHs quality system incl. corrective and preventive actions |
Awareness of post-authorisation studies requested by competent authorities |
Receive compliance information |
Ensure submission of all PV related documents |
Obtain information from the safety database |
Ensure quality, correctness and completeness of PV data submitted |
Be involved in due diligence process as early as possible, e.g. for acquisitions |
Ensure full and correct responses to safety related requests from competent authorities |
Determine what PV data shall be exchanged in contractual arrangements, e.g. SDEAs/PVAs |
Provide any other information relevant to the benefit-risk evaluation to the competent authorities |
Act as a single PV contact for competent authorities on a 24/7 basis |
Provide input into preparation of regulatory action response to emerging safety concerns |
Responsibility for the pharmacovigilance system means that the QPPV has oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals and teams, provided that the QPPV maintains system oversight and overview of the safety profiles of all products.
Thus, the EU/EEA QPPV role is not only critical to meeting the legal obligation of the MAH, but it is also an important component of the PV system to ensure patient safety and smooth business operations.
Cross-functional collaboration in pharmacovigilance is critical to ensuring that product safety issues are identified and addressed accordingly. The QPPV is in a very unique situation by being involved with several different functional teams and forums for all the medicinal products in the given pharmacovigilance system. The QPPV is the key person to support the cooperation and information flow between the different teams.
Examples of different teams, and their roles in PV system:
One of the most important responsibilities of the QPPV is to gain oversight and governance of the PV system, including performance monitoring and role of the QPPV. Usually, it could relate to some specific aspect of the PV system, e.g. aRMMs, clinical trials, vendors, and agreements. MAH is responsible to support and empower the EU/UK QPPV by means of documents, processes, communication mechanisms, resources, and access to all sources of relevant information to ensure the QPPV can fulfill responsibilities and gain overview of the PV system.
Examples of the ways to enhance the QPPV oversight are:
The QPPV is the key person to implement and maintain the PV system and oversee the benefit risk profile of your products. As a key interface within the marketing authorization holder’s cross-functional team, the QPPV helps to bring a product to the market and keep it on the market.
Apart from oversight, the QPPV consults the marketing authorization holder on commitments towards health authorities, Risk Management Plan, risk minimization activities, Safety Data Exchange Agreements, Post Authorisation Safety Studies, and much more.
ProPharma has a well-established QPPV office team including 20 QPPVs available. If you need a QPPV to support your products, contact the team at ProPharma today and tell us how we can help.
EU/EEA QPPV
Vice President, QPPV Office
TAGS: QPPV Pharmacovigilance
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