- 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
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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
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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
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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
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?
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
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?
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
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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
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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
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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
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