Module 6

03/10/2024

Good Pharmacovigilance Practices (EU GVPs) Overview of European Union GVP guidelines

Legal basis: Implementing Regulation EU 520/2012; Regulation EC 726/2004; Article 108a of Directive 2001/83/EC

Introductory Cover Note

Links to non-GVP guidance

Process M odules: I PV Quality Systems II PSMF Rev 2 III PV inspections Rev 1

A nnex I: Definitions

A nnex IV: ICH Guidance 1 2 3 4 5 6 7

P opulation- or Product Specific Considerations:

A nnex II: Templates 1 2

I Vaccines II Biologicals

IV PV audits Rev 1 V RM Systems Rev 2

A nnex V: Abbreviations

III Preg/Breastfeeding IV Paediatric population V Geriatric population

VI ICSR processing Rev2 VI Addendum I Duplicates VII PSUR Rev 1 VIII PASS Rev 3 VIII Addendum I Rev 2 IX Signals Rev 1 IX Addendum I Stats X Additional monitoring  XV Safety Comms Rev1 XVI RMM tools & effectiveness Rev2

A nnex III: Guidance prior to GVP 1 2 3 4 5 6 7 8 9

GVP Archive

Mueller M, Lewis DJ, Alexe A. The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor? Br J Clin Pharmacol. 2022 Oct 20. doi: 10.1111/bcp.15573. Epub ahead of print. PMID: 36264908.

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices

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Role of the QPPV ( EU QPPV )

EU Qualified Person bears the responsibility ” for:

● Establishing and maintaining the MAH’s PV system ● Having an overview of safety profiles and any emerging safety concerns related to medicinal products for which MAH holds authorisation ● Acting as a single point of contact on a 24 hour basis “Responsibility” means that EU QPPV must have a complete oversight of the PV system in terms of structure and performance either directly or through supervision

MAH shall ensure that EU QPPV has sufficient authority to influence the performance of the PV system

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