Search the website

Search results

22 results

Sort by

List item

Press release: Eye injuries in people and dogs when using Osurnia ear gel for dogs

CVMP, Last updated: 20/04/2018
List item

News: Highlights of Management Board: October 2020 meeting

MB, Last updated: 05/10/2020
List item

CHMP rules of procedure (PDF/237.49 KB)

Adopted
First published: 19/03/2007
Last updated: 22/12/2020
EMEA/MB/87146/2007 - Revised 17 December 2020
List item

Imrestor: EPAR - Procedural steps taken and scientific information after authorisation (PDF/85.9 KB)

First published: 20/12/2018
Last updated: 13/10/2020
List item

CHMP post-authorisation summary of positive opinion for Opdivo (PDF/70.56 KB)

Adopted
First published: 14/10/2016
Last updated: 14/10/2016
EMA/CHMP/671272/2016
List item

Questions and answers on post approval change management protocols (PDF/111.68 KB)

First published: 13/04/2012
Last updated: 13/04/2012
Consultations dates: from 15/03/2012 to 31/10/2012
EMA/CHMP/CVMP/QWP/586330/2010
List item

Guideline on real-time release testing (formerly guideline on parametric release) - Revision 1 (PDF/97.15 KB)

Adopted
First published: 13/04/2012
Last updated: 13/04/2012
Legal effective date: 01/10/2012
Consultations dates: from 15/03/2012 to 31/10/2012
EMA/CHMP/QWP/811210/2009-Rev1
List item

Draft guideline on process validation - Revision 1 (PDF/123.75 KB)

Draft: consultation closed
First published: 13/04/2012
Last updated: 13/04/2012
Consultations dates: from 15/03/2012 to 31/10/2012
EMA/CHMP/CVMP/QWP/70278/2012-Rev1
List item

2009 EudraVigilance-Human Status Report (PDF/263.2 KB)

First published: 08/10/2010
Last updated: 08/10/2010
EMA/MB/599720/2010
List item

Management Board consultation procedure for CHMP and CVMP nominations - Management Board meeting 18 March 2010 (PDF/102.28 KB)

Adopted
First published: 26/03/2010
Last updated: 26/03/2010
EMA/MB/281553/2007 Rev.2
List item

Status report on EudraVigilance implementation: Human medicinal products (PDF/107.78 KB)

Adopted
First published: 01/10/2009
Last updated: 01/10/2009
EMEA/MB/472819/2009
List item

Status Report on the EudraVigilance-Human Project (PDF/149.3 KB)

First published: 05/03/2009
Last updated: 05/03/2009
EMEA/MB/45112/2009
List item

P/0133/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for eszopiclone (EMEA-002309-PIP01-17) (PDF/67.04 KB)

Adopted
First published: 28/11/2018
EMA/209351/2018
List item

Overview of comments received on ' Draft Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken’ (EMA/CHMP/CVMP/JEG-3R (PDF/87.44 KB)

First published: 04/12/2018
EMA/CHMP/CVMP/3Rs/731086/2016
List item

P/0398/2018: EMA decision of 6 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP05-13-M03) (PDF/163.71 KB)

Adopted
First published: 15/02/2019
EMA/775548/2018
List item

Minutes of the 104th meeting of the Management Board (PDF/234.79 KB)

Adopted
First published: 07/10/2019
EMA/MB/335139/2019
List item

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial veterinary medicinal products (PDF/228.36 KB)

Adopted
First published: 10/07/2019
EMA/CVMP/CHMP/682199/2017
List item

Minutes of the CVMP meeting of 18-20 May 2020 (PDF/266.05 KB)

Adopted
First published: 26/06/2020
EMA/CVMP/326595/2020
List item

Guideline on the quality of water for pharmaceutical use (PDF/269.52 KB)

Adopted
First published: 20/07/2020
Legal effective date: 01/02/2021
EMA/CHMP/CVMP/QWP/496873/2018
List item

Overview of comments received on 'Answer to the request from the EC for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial vet products (PDF/265.54 KB)

Adopted
First published: 10/07/2019
EMA/CVMP/CHMP/201533/2019
List item

2019 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission - Reporting period: 1 January to 31 December 2019 (PDF/810.33 KB)

First published: 20/03/2020
EMA/640614/2019
List item

Overview of comments received on the draft 'Guideline on the quality of water for pharmaceutical use' (EMA/CHMP/CVMP/QWP/496873/2018) (PDF/204.33 KB)

First published: 20/07/2020
EMA/CHMP/CVMP/QWP/230700/2020

22 results

Press release: Eye injuries in people and dogs when using Osurnia ear gel for dogs

News: Highlights of Management Board: October 2020 meeting

CHMP rules of procedure (PDF/237.49 KB)

Imrestor: EPAR - Procedural steps taken and scientific information after authorisation (PDF/85.9 KB)

CHMP post-authorisation summary of positive opinion for Opdivo (PDF/70.56 KB)

Questions and answers on post approval change management protocols (PDF/111.68 KB)

Guideline on real-time release testing (formerly guideline on parametric release) - Revision 1 (PDF/97.15 KB)

Draft guideline on process validation - Revision 1 (PDF/123.75 KB)

2009 EudraVigilance-Human Status Report (PDF/263.2 KB)

Management Board consultation procedure for CHMP and CVMP nominations - Management Board meeting 18 March 2010 (PDF/102.28 KB)

Status report on EudraVigilance implementation: Human medicinal products (PDF/107.78 KB)

Status Report on the EudraVigilance-Human Project (PDF/149.3 KB)

P/0133/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for eszopiclone (EMEA-002309-PIP01-17) (PDF/67.04 KB)

Overview of comments received on ' Draft Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken’ (EMA/CHMP/CVMP/JEG-3R (PDF/87.44 KB)

P/0398/2018: EMA decision of 6 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP05-13-M03) (PDF/163.71 KB)

Minutes of the 104th meeting of the Management Board (PDF/234.79 KB)

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial veterinary medicinal products (PDF/228.36 KB)

Minutes of the CVMP meeting of 18-20 May 2020 (PDF/266.05 KB)

Guideline on the quality of water for pharmaceutical use (PDF/269.52 KB)

Overview of comments received on 'Answer to the request from the EC for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial vet products (PDF/265.54 KB)

2019 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission - Reporting period: 1 January to 31 December 2019 (PDF/810.33 KB)

Overview of comments received on the draft 'Guideline on the quality of water for pharmaceutical use' (EMA/CHMP/CVMP/QWP/496873/2018) (PDF/204.33 KB)