Appointment of the Qualified Person for Pharmacovigilance (QPPV)

It is a mandatory requirement for all the medicinal products authorized in the European Union to appoint a Qualified Person for Pharmacovigilance (QPPV). QPPV is responsible for ensuring that the Marketing Authorization Holders comply with the EU, UK, and Australian regulatory requirements. We are experienced in providing an experienced QPPV to oversee and support our client’s portfolio.

QPPV will establish and maintain the PV system in EU countries.
They will also be promoting, improving, and maintaining legal compliance requirements within the European Union, UK, and Australian region.
QPPV will also maintain the awareness of risk and have minimization measures for the medicinal product. They will have authority over the Risk Management Plan content.
They will review and approve the protocols of any Post Authorization Safety Studies in European Region.
Ensure all the documents related to pharmacovigilance are in accordance with legal requirements. They will also check the correctness of the data submitted to the competent authorities.
QPPV will also oversee the emerging safety concerns and safety profiles relating to the medical products covered by the PSMF.
A QPPV is highly important for a pharma company as it will act as a single point of contact for the EMA, and Competent Authorities (CAs).
They will provide prompt responses to the CA’s requests and also provide input regarding the preparation of regulatory action in the European Union.