Pharmacovigilance inspections for veterinary medicines
The European Medicines Agency (EMA) has developed procedures for the coordination, conduct and reporting of pharmacovigilance inspections carried out in the context of the centralised procedure for veterinary medicines.
These inspections are adopted by the Committee for Medicinal Products for Veterinary Use (CVMP). They may be routine, or triggered by issues arising during the assessment of pharmacovigilance data or by other information such as previous inspection experience.
For more information on pharmacovigilance inspections and EMA's role, please refer to the content in the human regulatory section:
If you have questions regarding this content, Send a question to the European Medicines Agency
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Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections (PDF/294.91 KB)
First published: 29/11/2022
EMA/INS/PhV/604648/2022 -
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Appendix 1 - Pharmacovigilance Inspection Report template (DOC/335 KB)
First published: 29/11/2022 -
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Appendix 2 - Template for collecting information on Pharmacovigilance issues for the attention of the inspectors and assessors (DOC/42 KB)
First published: 29/11/2022 -
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Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections (PDF/584.35 KB)
First published: 29/11/2022
EMA/INS/PhV/773932/2022 – Rev 01 -
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Pharmacovigilance Inspection policy for centralised procedures - medicinal products for veterinary use (PDF/49.07 KB)
First published: 27/11/2009
Last updated: 27/11/2009
EMEA/INS/PhV/384646/2008 -
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Procedure for the preparation of a risk-based programme for routine pharmacovigilance inspections of MAHs connected with veterinary Centrally Authorised Products (CAPs) (PDF/68.69 KB)
Adopted
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/INS/PhV/390778/2008 -
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Procedure for coordinating pharmacovigilance inspections requested by the CVMP (PDF/86.67 KB)
Adopted
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/INS/PhV/85059/2008
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Procedure for conducting pharmacovigilance inspections requested by the CVMP (PDF/67.45 KB)
Adopted
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/INS/PhV/85058/2008 -
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Procedure for reporting of pharmacovigilance inspections requested by the CVMP (PDF/141.05 KB)
Adopted
First published: 20/04/2009
Last updated: 17/12/2014
EMEA/INS/PhV/226163/2014 -
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Appendix 1 - Pharmacovigilance inspection report template (Vet) (DOC/355 KB)
First published: 02/02/2015
Last updated: 04/04/2016 -
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Appendix 2 - Pharmacovigilance inspection overview template (DOC/250 KB)
First published: 02/02/2015
Last updated: 02/02/2015 -
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Appendix 3 - Pharmacovigilance inspection information collection template (DOC/39.5 KB)
First published: 02/02/2015
Last updated: 02/02/2015