EU QPPV service
According to Directive 2010/84/EU of the European Parliament and of the Council and GVP guidelines each marketing authorisation holder (MAH) shall permanently and continuously have at its disposal an appropriately qualified person responsible for pharmacovigilance within the European Union (EU QPPV).
What is the EU QPPV responsible for?
As the QPPV is responsible for the establishment and maintenance of the MAH’s pharmacovigilance system (PV system), the person should be appropriately qualified and needs to have sufficient authority to have an impact on the quality system performance and the PV activities.
On the top of that the EU QPPV is responsible for the fulfillment of key PV function areas such as:
- Acting as a single PV contact point for the competent authorities in Member States and the Agency on a 24-hour basis,
- Establishing and maintenance of the MAH’s PV system,
- Ensure that the Pharmacovigilance System Master File (PSMF) is constantly up to date,
- Having an overview of medicinal product safety profiles and any emerging safety concerns,
- Having awareness of risk minimisation measures,
- Acting as a contact point for any PV audits or inspections.
What does EU QPPV oversee?
| Pharmacovigilance system master file | Signal management | Quality management system |
| Agreements management | Literature monitoring | ICSR and SUSAR management |
| PV training | Safety reports management | Standard operating procedures |
What requirements EU QPPV needs to meet?
EU QPPV must reside and operate in the EU, Norway, Iceland, or Liechtenstein. Moreover, EU QPPV has to be appropriately qualified, should be permanently and continuously at the MAH´s disposal, and must be experienced in all aspects of PV.
SciencePharma’s QPPV has extensive knowledge and industry experience. By choosing our QPPV service you can be sure that PV of your products is in good hands! Moreover, our QPPV is being constantly trained in PV and therefore is up to date with any new requirements.
Outsourcing EU QPPV can bring many benefits to your business – time and cost efficiency are just a few examples – to find out more, please contact us!
Should you wish to save your precious time, money and resources please click on the link and contact us – our team will be more than happy to talk you through all the steps to have EU QPPV outsourced in our company.