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News: Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) - deadline extended

PRAC, Last updated: 20/11/2020
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News: Paediatric Committee elects Koenraad Norga as its new chair

PDCO, Last updated: 24/07/2019
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News: Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations

COMP, Last updated: 24/11/2020
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Orphan medicines figures 2000-2021 (PDF/259.86 KB)

First published: 16/04/2015
Last updated: 06/04/2022
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HMPC rules of procedure (PDF/182.38 KB)

First published: 05/11/2009
Last updated: 15/10/2021
EMA/HMPC/139800/2004 Rev. 5
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Clynav : EPAR - Medicine overview (PDF/123.75 KB)

First published: 20/07/2017
Last updated: 25/09/2020
EMA/278771/2016
Bulgarian
(PDF/147.73 KB)

Croatian
(PDF/154.74 KB)

Czech
(PDF/143.66 KB)

Danish
(PDF/122.02 KB)

Dutch
(PDF/124.55 KB)

Estonian
(PDF/121.65 KB)

Finnish
(PDF/121.56 KB)

French
(PDF/114.31 KB)

German
(PDF/129.27 KB)

Greek
(PDF/145.86 KB)

Hungarian
(PDF/146.53 KB)

Italian
(PDF/122.79 KB)

Latvian
(PDF/152.07 KB)

Lithuanian
(PDF/143.91 KB)

Maltese
(PDF/155.45 KB)

Polish
(PDF/155.98 KB)

Portuguese
(PDF/125.69 KB)

Romanian
(PDF/143.1 KB)

Slovak
(PDF/145.87 KB)

Slovenian
(PDF/144.17 KB)

Spanish
(PDF/124.64 KB)

Swedish
(PDF/122.73 KB)
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Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs) (PDF/211.11 KB)

Adopted
First published: 10/05/2017
Last updated: 10/05/2017
Legal effective date: 05/05/2017
SOP/V/4150
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Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (PDF/174.36 KB)

Adopted
First published: 07/05/2015
Last updated: 10/02/2016
Legal effective date: 08/02/2016
WIN/V/4035
List item

Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP (PDF/134.5 KB)

Adopted
First published: 07/05/2015
Last updated: 07/05/2015
Legal effective date: 01/05/2015
WIN/V/4001
List item

Standard Operating Procedure for MRL Procedure: Submission of Dossiers to the Members of the Committee for Veterinary Medicinal Products (PDF/18.14 KB)

Adopted
First published: 10/12/2007
Last updated: 10/12/2007
Legal effective date: 10/12/2007
EMEA/CVMP/819/99-Annex 1
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Standard Operating Procedure for Submission and evaluation procedure for an application for the establishment of Maximum Residue Limits (MRLs) (PDF/108.72 KB)

Adopted
First published: 01/03/2006
Last updated: 01/03/2006
Legal effective date: 01/03/2006
EMEA/CVMP/819/99-Rev.5
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Standard Operating Procedure for Management of 15-day Suspected Adverse Reaction (SAR) reports to a centrally authorised veterinary medicinal product (PDF/154.02 KB)

Adopted
First published: 09/12/2005
Last updated: 09/12/2005
Legal effective date: 09/12/2005
CVMP/SOP/693/99-Rev.2
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PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 June 2019 (PDF/150.99 KB)

First published: 17/07/2019
EMEA/PDCO/380229/2019
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Minutes of the COMP meeting on 11-13 April 2022 (PDF/451.83 KB) (new)

Adopted
First published: 16/06/2022
EMA/COMP/214405/2022
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Minutes - PDCO minutes of the 19-22 April 2022 meeting (PDF/428.32 KB) (new)

Adopted
First published: 16/06/2022
EMA/PDCO/247621/2022
List item

Agenda - PDCO agenda of the 21-24 June 2022 meeting (PDF/1.07 MB) (new)

First published: 21/06/2022
EMA/PDCO/557550/2022
List item

Minutes of the CVMP meeting of 10-12 May 2022 (PDF/270.67 KB) (new)

Adopted
First published: 24/06/2022
EMA/CVMP/587361/2022

17 results

News: Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) - deadline extended

News: Paediatric Committee elects Koenraad Norga as its new chair

News: Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations

Orphan medicines figures 2000-2021 (PDF/259.86 KB)

HMPC rules of procedure (PDF/182.38 KB)

Clynav : EPAR - Medicine overview (PDF/123.75 KB)

Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs) (PDF/211.11 KB)

Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (PDF/174.36 KB)

Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP (PDF/134.5 KB)

Standard Operating Procedure for MRL Procedure: Submission of Dossiers to the Members of the Committee for Veterinary Medicinal Products (PDF/18.14 KB)

Standard Operating Procedure for Submission and evaluation procedure for an application for the establishment of Maximum Residue Limits (MRLs) (PDF/108.72 KB)

Standard Operating Procedure for Management of 15-day Suspected Adverse Reaction (SAR) reports to a centrally authorised veterinary medicinal product (PDF/154.02 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 June 2019 (PDF/150.99 KB)

Minutes of the COMP meeting on 11-13 April 2022 (PDF/451.83 KB) (new)

Minutes - PDCO minutes of the 19-22 April 2022 meeting (PDF/428.32 KB) (new)

Agenda - PDCO agenda of the 21-24 June 2022 meeting (PDF/1.07 MB) (new)

Minutes of the CVMP meeting of 10-12 May 2022 (PDF/270.67 KB) (new)