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.

VICH GL35: Pharmacovigilance: electronic standards for transfer of data

Adopted Reference Number: EMA/CVMP/VICH/123940/2006 Rev 1 Legal effective date: 31/12/2015 Summary:

The objective of this guideline is to provide standards to construct a single electronic message to transmit GL42 contents to all regions.

VICH GL24: Guideline on pharmacovigilance of veterinary medicinal products -Management of adverse event reports (AERS)

Adopted Reference Number: EMA/CVMP/VICH/547/2000 Legal effective date: 31/12/2015

VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs)

Adopted Reference Number: EMEA/CVMP/VICH/355996/2005 Rev 1 Legal effective date: 31/12/2015

VICH GL30 on pharmacovigilance of veterinary medicinal products: controlled list of terms

Adopted Reference Number: EMA/CVMP/VICH/647/2001 Legal effective date: 31/12/2015

VICH GL29: Guideline on pharmacovigilance of veterinary medicinal products -Management of periodic summary update reports - Step 7

Adopted Reference Number: EMEA/CVMP/VICH/646/01 Legal effective date: 01/06/2007

Management of adverse event reports

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.

VICH GL24: Guideline on pharmacovigilance of veterinary medicinal products -Management of adverse event reports (AERS)

Adopted Reference Number: EMA/CVMP/VICH/547/2000 Legal effective date: 31/12/2015

VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs)

Adopted Reference Number: EMEA/CVMP/VICH/355996/2005 Rev 1 Legal effective date: 31/12/2015

VICH GL30 on pharmacovigilance of veterinary medicinal products: controlled list of terms

Adopted Reference Number: EMA/CVMP/VICH/647/2001 Legal effective date: 31/12/2015

Management of periodic summary update reports - Step 7

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.

VICH GL29: Guideline on pharmacovigilance of veterinary medicinal products -Management of periodic summary update reports - Step 7

Adopted Reference Number: EMEA/CVMP/VICH/646/01 Legal effective date: 01/06/2007