PrimeVigilance offers experienced UK QPPVs, and UK national contact persons for PV and deputies with extensive knowledge and experience of the industry
The marketing authorization holder (MAH) must have permanently and continuously at its disposal a Qualified Person responsible for Pharmacovigilance who is responsible for the establishment and maintenance of the pharmacovigilance system for the UK nationally authorized products.
UK QPPV can reside and operate anywhere in the UK or the EU/EEA.
UK QPPV is responsible for the fulfillment of key PV functions:
Establishing and maintenance of the MAH’s pharmacovigilance (PV) system and therefore shall have sufficient authority to influence the performance of the quality system and the PV activities and to promote, maintain and improve compliance with the legal requirements
Having an overview of medicinal product safety profiles and any emerging safety concerns
Acting as a single PV contact point for the MHRA on a 24-hour basis, and the contact point for inspections
UK QPPV shall be appropriately qualified, shall be at the MAH´s disposal permanently and continuously, and must be experienced in all aspects of PV.
If UK QPPV resides and operates in the EU, then MAH must nominate UK national contact person for PV who:
Resides and operates in UK and reports to the EU QPPV
Has access to the reports of suspected adverse reactions and the PSMF
Facilitates responses to PV queries raised by the MHRA, including via inspections.
Why Outsource Your UK QPPV and UK national contact person for PV?
Recruiting and appointing your UK QPPV and UK national contact person for PV can consume a great deal of your time and resources. Our support allows for a greater economy without sacrificing quality.
PrimeVigilance UK QPPVs and UK national contact person for PV have extensive knowledge and experience of the industry.
Our experienced UK QPPVs and UK national contact persons for PV can work within your PV system which has been outsourced to PrimeVigilance.
PrimeVigilance can audit your existing UK QPPV and PV system and identify gaps in oversight and advice on optimal arrangements, recommending corrective actions to ensure your PV system meets the requirements of the legislation.
References European Medicines Agency. 22 June 2012 EMA/541760/2011. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems. MHRA Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) (31Dec2020)