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What are the obligations that a QPPV must perform?

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Published on LexisPSL on 17/10/2017

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

  • What are the obligations that a QPPV must perform?

What are the obligations that a QPPV must perform?

Article 104(3) of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes the requirement for the marketing authorisation holder (MAH) of a medicinal product to ‘have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.’ This requirement is implemented into UK law by the regulation 182 of the Human Medicines Regulations 2012, SI 2012/1916.

The Qualified Person for Pharmacovigilance (QPPV) is responsible for the establishment and maintenance of the MAH’s pharmacovigilance (PV) system. In relation to the medicinal products covered by the PV system, the Guidelines on good Pharmacovigilance practices (GVP)(PV Guidance) states that:

‘specific additional responsibilities of the QPPV should include:

  1. having an overview of medicinal product safety profiles and any emerging safety concerns

  2. having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products

  3. having awareness of risk minimisation measures

  4. being aware of and having sufficient

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