Qppv

How to be an EU QPPV… What You Need to Know and what’s new
Elspeth McIntosh Director Castle Pharmacovigilance Ltd Keith Wibley Director, Pharmacovigilance, NDA Regulatory Science Ltd

5th European Forum for QPPV
10 May 2011 London

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Is A QPPV Needed?
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Anyone marketing a medicinal product in any of the 27 MemberStates of the European Union (EU) or the 3 EEA Member States (Iceland, Liechtenstein and Norway) must have a QPPV. Also anyone applying to market a product in the above countries must prove they have the services of a QPPV in their MAA. Applies to all MAA procedures (centralised, decentralised, MR, national). Clinical trail Sponsors don’t need a QPPV.
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Can there only be 1 QPPV?
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There can be only one for each PV system • Volume 9A, Part I, Section 1.2: “Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketingauthorisations within the EU”. EU Can be one QPPV for separate PV systems (e.g. one each for OTC, pharmaceuticals and vaccine divisions) National responsible people can still be appointed if required by national law (e.g. in Germany and France). In new EU PV legislation these people must report to QPPV.

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Location of the QPPV
• Current EUlegislation requires that the QPPV “shall reside in the Community” • New legislation requires the QPPV to “reside and operate in the Union” Deputy/back up • Deputy/back-up for QPPV must also reside in EU (Volume 9A, Part I, Section 1.2.1) • EEA as well as EU Member States are acceptable

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Obligations of MAH and QPPV • MAH and QPPV have overlapping andinterdependent obligations as regards pharmacovigilance. • Both need to be involved in establishing and managing the pharmacovigilance system.

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Who is liable for Compliance?

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MAH or QPPV? BOTH…need mutual oversight of each other QPPV is a function of MAH and has specific personal responsibilities and liabilities (similar to GMPQPs) MAH has overall responsibility f its MAs, is for legally liable both under pharmaceutical and consumer protection laws, and is ultimately responsible for the quality of the QPPV.

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MAH’s Responsibilities to the QPPV

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Described in Volume 9A, Part I, Section 1.2.2 • “The Marketing Authorisation Holder should adequately support theQPPV and ensure that there are appropriate processes, resources, communication mechanisms and access to all sources of relevant information in place for the fulfilment of the QPPV s responsibilities and QPPV’s tasks.” MAH should provide the following for QPPV: • Documented responsibilities (job description) • Procedures concerning QPPV • Supply of risk/benefit information to QPPV, including...