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Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (PDF/2.56 MB) (updated)

Adopted
First published: 22/07/2009
Last updated: 24/06/2022
Legal effective date: 01/10/2021
EMA/CVMP/PhVWP/10418/2009 Rev.13
List item

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel) (XLS/559 KB) (updated)

Adopted
First published: 22/07/2009
Last updated: 24/06/2022
EMA/CVMP/PhVWP/10418/2009 Rev.13
List item

Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans (PDF/209.51 KB) (updated)

First published: 21/07/2008
Last updated: 24/06/2022
EMA/CVMP/PhVWP/288284/2007 Rev.14
List item

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products (PDF/718.54 KB) (updated)

Adopted
First published: 19/07/2010
Last updated: 24/06/2022
EMA/CVMP/PhVWP/237953/2022
List item

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022 (PDF/230.86 KB) (updated)

First published: 04/02/2022
Last updated: 24/06/2022
EMA/CVMP/PhVWP/48138/2022
List item

Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF/215.85 KB) (updated)

Adopted
First published: 23/09/2009
Last updated: 24/06/2022
EMA/CVMP/519714/2009 Rev. 52
List item

EU/3/17/1872: Public summary of opinion on orphan designation: Chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p for the treatment of cutaneou... (PDF/227.99 KB) (updated)

Adopted
First published: 29/06/2017
Last updated: 22/06/2022
EMA/274810/2017
List item

EU/3/07/518: Public summary of positive opinion for orphan designation of methyl 4, 6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3, 4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate for the treatment of pulmonary arteria... (PDF/232.11 KB) (updated)

Adopted
First published: 23/09/2009
Last updated: 14/06/2022
EMEA/COMP/35953/2008 Rev.3
List item

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Signifor (pasireotide) for the treatment of Cushing’s disease (PDF/116.58 KB) (updated)

Adopted
First published: 29/06/2012
Last updated: 14/06/2022
EMA/COMP/93349/2012
List item

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Adempas (riociguat) for the treatment of pulmonary arterial hypertension including chronic thromboembolic pulmonary hypertensio... (PDF/144.2 KB) (updated)

Adopted
First published: 24/04/2014
Last updated: 14/06/2022
EMA/COMP/68649/2014
List item

EU/3/09/671: Public summary of positive opinion for orphan designation of pasireotide for the treatment of Cushing’s disease (PDF/188.29 KB) (updated)

Adopted
First published: 20/10/2009
Last updated: 14/06/2022
EMEA/COMP/455317/2009 Rev. 2
List item

EU/3/13/1215: Public summary of opinion on orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabi... (PDF/230.98 KB) (updated)

Adopted
First published: 22/01/2014
Last updated: 14/06/2022
EMA/COMP/699781/2013
List item

EU/3/13/1217: Public summary of opinion on orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabi... (PDF/232.67 KB) (updated)

Adopted
First published: 22/01/2014
Last updated: 14/06/2022
EMA/COMP/700146/2013
List item

Template - Translations required with the submission of an application for orphan medicinal product designation (DOC/70.5 KB) (updated)

First published: 10/12/2009
Last updated: 09/06/2022
List item

Recommended submission dates for veterinary medicinal products (PDF/688.86 KB) (updated)

Adopted
First published: 01/07/2009
Last updated: 08/06/2022
EMA/587410/2021 Rev.5
List item

Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans - in relation to implementing measures under Article 37(5) of Regulation (EU) 2019/6 on veterinary medicinal products (PDF/2.89 MB) (updated)

Adopted
First published: 01/03/2022
Last updated: 07/06/2022
EMA/CVMP/678496/2021
List item

EU/3/20/2264: Public summary of opinion on orphan designation for trifarotene for the treatment of autosomal recessive congenital ichthyosis (PDF/228.32 KB) (updated)

Adopted
First published: 12/08/2020
Last updated: 07/06/2022
EMADOC-628903358-2103
List item

EudraVigilance access policy for medicines for veterinary use - Revision 2.1 (PDF/440 KB) (updated)

Adopted
First published: 18/06/2021
Last updated: 01/06/2022
Legal effective date: 28/01/2022
EMA/113700/2008 Rev. 2.1
List item

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data (PDF/393.5 KB)

First published: 16/12/2021
Last updated: 20/05/2022
EMA/717215/2021
List item

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.61 MB)

Adopted
First published: 21/01/2021
Last updated: 20/05/2022
EMA/444352/2021
List item

EU/3/17/1856: Public summary of opinion on orphan designation: Inebilizumab for the treatment of neuromyelitis optica spectrum disorders (PDF/200.88 KB)

Adopted
First published: 05/05/2017
Last updated: 19/05/2022
EMA/144977/2017
List item

EU/3/15/1555: Public summary of opinion on orphan designation: Synthetic hepcidin for the treatment of beta thalassaemia intermedia and major (PDF/185.88 KB)

Adopted
First published: 16/11/2015
Last updated: 18/05/2022
EMA/COMP/615273/2015
List item

EU/3/07/478: Public summary of positive opinion for orphan designation of N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide for the treatment of Hodgkin's lymphoma (PDF/317.04 KB)

Adopted
First published: 23/09/2009
Last updated: 10/05/2022
EMEA/COMP/389996/2007 Rev.1
List item

EU/3/13/1228: Public summary of opinion on orphan designation: Obeticholic acid for the treatment of primary sclerosing cholangitis (PDF/187.38 KB)

Adopted
First published: 24/03/2014
Last updated: 10/05/2022
EMA/COMP/18109/2014
List item

Change of applicant checklist - pre-submission guidance (veterinary) (PDF/178.27 KB)

First published: 01/10/2018
Last updated: 03/05/2022
EMA/603587/2018

7528 results

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (PDF/2.56 MB) (updated)

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel) (XLS/559 KB) (updated)

Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans (PDF/209.51 KB) (updated)

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products (PDF/718.54 KB) (updated)

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022 (PDF/230.86 KB) (updated)

Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF/215.85 KB) (updated)

EU/3/17/1872: Public summary of opinion on orphan designation: Chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p for the treatment of cutaneou... (PDF/227.99 KB) (updated)

EU/3/07/518: Public summary of positive opinion for orphan designation of methyl 4, 6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3, 4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate for the treatment of pulmonary arteria... (PDF/232.11 KB) (updated)

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Signifor (pasireotide) for the treatment of Cushing’s disease (PDF/116.58 KB) (updated)

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Adempas (riociguat) for the treatment of pulmonary arterial hypertension including chronic thromboembolic pulmonary hypertensio... (PDF/144.2 KB) (updated)

EU/3/09/671: Public summary of positive opinion for orphan designation of pasireotide for the treatment of Cushing’s disease (PDF/188.29 KB) (updated)

EU/3/13/1215: Public summary of opinion on orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabi... (PDF/230.98 KB) (updated)

EU/3/13/1217: Public summary of opinion on orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabi... (PDF/232.67 KB) (updated)

Template - Translations required with the submission of an application for orphan medicinal product designation (DOC/70.5 KB) (updated)

Recommended submission dates for veterinary medicinal products (PDF/688.86 KB) (updated)

Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans - in relation to implementing measures under Article 37(5) of Regulation (EU) 2019/6 on veterinary medicinal products (PDF/2.89 MB) (updated)

EU/3/20/2264: Public summary of opinion on orphan designation for trifarotene for the treatment of autosomal recessive congenital ichthyosis (PDF/228.32 KB) (updated)

EudraVigilance access policy for medicines for veterinary use - Revision 2.1 (PDF/440 KB) (updated)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data (PDF/393.5 KB)

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.61 MB)

EU/3/17/1856: Public summary of opinion on orphan designation: Inebilizumab for the treatment of neuromyelitis optica spectrum disorders (PDF/200.88 KB)

EU/3/15/1555: Public summary of opinion on orphan designation: Synthetic hepcidin for the treatment of beta thalassaemia intermedia and major (PDF/185.88 KB)

EU/3/07/478: Public summary of positive opinion for orphan designation of N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide for the treatment of Hodgkin's lymphoma (PDF/317.04 KB)

EU/3/13/1228: Public summary of opinion on orphan designation: Obeticholic acid for the treatment of primary sclerosing cholangitis (PDF/187.38 KB)

Change of applicant checklist - pre-submission guidance (veterinary) (PDF/178.27 KB)