2020年12月31日 · Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance is supplemented by the Exceptions and...

2020年12月31日 · The QPPV for UK nationally authorised products (including both Category 1 and Category 2 products as well as PLNI licenses and PLGBs) ) can reside and operate anywhere in the UK or the EU/EEA...

2025年1月8日 · In the first instance, this correspondence will be done via the Qualified Person for Pharmacovigilance (QPPV) but a different or additional contact for future correspondence can be nominated.

2024年5月30日 · Learn about the essential role of the Qualified Person Responsible for Pharmacovigilance (QPPV) who ensures compliance and oversight in the EU/UK PV system.

On 4th September 2020, the MHRA issued preliminary guidance on the role of the Qualified Person for Pharmacovigilance (QPPV) for MAHs in the UK or Great Britain (GB), the “QPPV”. This was superseded on the 31st December 2020 by guidance on the requirement for In parallel, the Northern Ireland (NI) Protocol was issued in December 2020.

2009年1月7日 · The PSMF must be located either at the site in the Union where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the Union where the QPPV operates.

2021年2月12日 · Guidance on the UK qualified person for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF), as well as submission of the summary of pharmacovigilance system...

2023年10月25日 · Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance is supplemented by the Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders .

In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No ...

Currently, there are 2 different options to remain compliant with UK law: The MA has 2 QPPVs, a UK QPPV covering the UK (including Northern Ireland) and an EU QPPV covering Northern Ireland only. A QPPV resident in the EU covers the entire UK …