Choose the Ideal Qualified Person for Pharmacovigilance (QPPV)
06 Apr 2023
Qualified Person for pPharmacovigilance (QPPV) acts as a main/single pharmacovigilance contact point for the competent authorities for Marketing Authorisation Holder (MAH) and the European Medicine Agency (EMA)/ the Medicines and Healthcare products Regulatory Agency (MHRA) on a 24- hour basis. They also serve as a contact point for all pharmacovigilance inspections by any competent authority/state authority and the EMA/MHRA.
UNITED KINGDOM:
The Marketing Authorisation Holder (MAH) for UK must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. The QPPV for UK nationally authorised products including those that cover Northern Ireland, Great Britain (England, Scotland and Wales) or the whole of the UK can reside and operate anywhere in the UK or the EU/EEA.
As per MHRA guidance, where QPPV does not reside or operate in the UK, there will be a need for a national contact person for pharmacovigilance who resides and operates in the UK for Marketing Authorisation Holder and is a single point of contact person for all pharmacovigilance queries.
EUROPEAN UNION:
A UK located QPPV shall not be accepted by EU Member states in circumstances where the Marketing Authorisation Holder (MAH) who does not have at his disposal, a QPPV located in the EU. Marketing Authorisation Holder (MAH) requires to appoint a separate EU Qualified person for pharmacovigilance and should reside in European Union.
In key points to summarise, QPPV supports on below responsibilities:
- Permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (QPPV) in the EU [DIR Art 104(3)(a)].
- Fulfils the role of EU/UK QPPV including pre-market approval and post marketing QPPV Support services in accordance with applicable legislations
- Guides MAH on the EEA/EU and UK regulatory agency safety requests
- Advises MAH on Pharmacovigilance system changes as appropriate
- Keeps oversight over the functioning of the system in all relevant aspects, including its quality management system (QMS)
- Support during merger and acquisition, QPPV plays a vital role for Pharmacovigilance legacy data management and transfer of data.
As a one stop solution provider, Lambda provides highly qualified QPPV and deputy QPPV having rich experience and expertise in Pharmacovigilance activities along with Quality Management System. Our QPPV services include:
- EU QPPV and Deputy QPPV - UK QPPV and Deputy QPPV - National Contact Person for UK