International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)
The European Medicines Agency (EMA) applies relevant guidelines of the Veterinary International Conference on Harmonisation (VICH) in the field of veterinary pharmacovigilance. These guidelines are available below.
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VICH GL35: Pharmacovigilance: electronic standards for transfer of data (PDF/1.84 MB)
Adopted
First published: 13/03/2013
Last updated: 22/05/2023
Legal effective date: 31/12/2015
EMA/CVMP/VICH/123940/2006 Rev 1 -
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VICH GL24: Guideline on pharmacovigilance of veterinary medicinal products -Management of adverse event reports (AERS) (PDF/201.73 KB)
Adopted
First published: 17/03/2008
Last updated: 16/12/2013
Legal effective date: 31/12/2015
EMA/CVMP/VICH/547/2000 -
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VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs) (PDF/488.85 KB)
Adopted
First published: 14/11/2005
Last updated: 22/05/2023
Legal effective date: 31/12/2015
EMEA/CVMP/VICH/355996/2005 Rev 1 -
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VICH GL30 on pharmacovigilance of veterinary medicinal products: controlled list of terms (PDF/163.61 KB)
Adopted
First published: 20/07/2006
Last updated: 16/12/2013
Legal effective date: 31/12/2015
EMA/CVMP/VICH/647/2001 -
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VICH GL29: Guideline on pharmacovigilance of veterinary medicinal products -Management of periodic summary update reports - Step 7 (PDF/93.17 KB)
Adopted
First published: 20/07/2006
Last updated: 20/07/2006
Legal effective date: 01/06/2007
EMEA/CVMP/VICH/646/01
Some of the definitions in the guideline below do not apply in European Union / European Economic Area after the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) took effect on 28 January 2022.
The guideline below does not apply in European Union / European Economic Area after the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) took effect on 28 January 2022.