Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

Union procedure on the preparation, conduct and

Metadata

Provider:

URL:

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/union-procedure-preparation-conduct-reporting-eu-pharmacovigilance-inspections_en.pdf

Retrieved on:

Mittwoch, April 3, 2024

Information

Geotags:

UNITED KINGDOM, IR, EUROPEAN UNION, PATRICK, EC, EU

Zusammenfassung

Key Points:

Union procedure on the preparation, conduct and
reporting of EU pharmacovigilance inspections
Table of contents
1.
Record management and archiving ....................................................................... 12
References ................................................................................................ 12
Appendix 1 ?Pharmacovigilance inspection report .................................... 13
Appendix 2- Inspection overview (IO) ...................................................... 14
Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
Appendix 4- Classification of inspection findings....................................... 16

Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014

Page 2/16

1.
Guidelines on the interpretation of legislative pharmacovigilance
requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
pharmacovigilance inspections.
Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
procedure on the coordination of EU pharmacovigilance inspections.
Scope
This procedure constitutes a guideline in preparing, conducting and reporting national competent
authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
Those are covered under the Union procedure on the
management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 3/16

3.
Preparation
Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
a pharmacovigilance inspection and prior to inspection conduct.
For the selection of involved
parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
pharmacovigilance inspections.
Announcement communications could include, for example, the
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014

Page 4/16

name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 5/16

?

Feedback from other competent authority functions, in particular pharmacovigilance assessors.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 6/16

?

If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
located off site etc.
?
Union procedure on the management of pharmacovigilance inspection findings which may impact
the robustness of the benefit-risk profile of the concerned medicinal products.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 12/16

Appendix 1 ?Pharmacovigilance inspection report
Click here for the template.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 13/16

Appendix 2- Inspection overview (IO)
Click here for the template.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 14/16

Appendix 3- Pharmacovigilance inspection outcome sharing
Click here for the template.
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
inspections
EMA/INS/PhV/192230/2014
Page 16/16