Q&As

Is there any prohibition against the subcontracting of QPPV services?

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Published on LexisPSL on 07/12/2017

The following Life Sciences Q&A provides comprehensive and up to date legal information covering:

  • Is there any prohibition against the subcontracting of QPPV services?

Is there any prohibition against the subcontracting of QPPV services?

The Guideline on good pharmacovigilance practices (GVP) (PV Guidance) provides that a marketing authorization holder (MAH) may subcontract certain activities of the pharmacovigilance (PV) system to third parties, including the role of Qualified Person for Pharmacovigilance (QPPV) (see page 18 of the PV Guidance).

The MAH nevertheless retains full responsibility for the completeness and accuracy of the pharmacovigilance system master file (PSMF). The ultimate responsibility for the fulfilment of all PV tasks and responsibilities and the quality and

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