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Rabitec-V-C-004387-II-0002 : EPAR - Assessment report - Variation (PDF/294.31 KB) (new)

Adopted
First published: 03/04/2020
EMA/56879/2020
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Rabitec : EPAR - Procedural steps taken and scientific information after authorisation (PDF/109.38 KB) (new)

First published: 03/04/2020
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Minutes of the CVMP meeting of 18-20 February 2020 (PDF/268.14 KB) (new)

Adopted
First published: 01/04/2020
EMA/CVMP/142728/2020
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News: Regulatory information - 1.6% increase in fees from 1 April 2020

Last updated: 01/04/2020
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Council Regulation (EC) No 297/95 as amended by Commission Regulation (EU) 2020/422 of 19 March 2020 adjusting the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020 (PDF/506.65 KB) (new)

First published: 01/04/2020
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Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2020 (PDF/888.69 KB) (new)

First published: 01/04/2020
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EMA Regulatory Science to 2025 - Strategic reflection (PDF/4.8 MB) (new)

Adopted
First published: 31/03/2020
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Press release: Advancing regulatory science in the EU – new strategy adopted

Last updated: 31/03/2020
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Analysis and summaries of public consultation results: EMA Regulatory Science to 2025 - Strategic reflection (PDF/1005.11 KB) (updated)

First published: 31/03/2020
Last updated: 02/04/2020
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Advancing regulatory science in the EU – new strategy adopted (PDF/102.51 KB) (new)

First published: 31/03/2020
EMA/132421/2020
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News: EMA to issue electronic certificates for medicines

Last updated: 30/03/2020
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10-year annual report on MUMS/limited market scheme for veterinary medicines (PDF/2.08 MB) (new)

First published: 25/03/2020
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News: Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species

Last updated: 25/03/2020
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Summary of transfers of appropriations in budget 2019 - Issues for consideration - Management Board meeting of 19 March 2020 (PDF/147.41 KB) (new)

First published: 20/03/2020
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Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2020 (PDF/453.48 KB) (new)

First published: 20/03/2020
EMA/MB/332998/2019
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Outcome of written procedures finalised during the period from 23 November 2019 to 20 February 2020 (PDF/149.37 KB) (new)

First published: 20/03/2020
EMA/MB/91576/2020
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CVMP summary of positive opinion for Lydaxx (PDF/61.75 KB) (new)

Adopted
First published: 20/03/2020
EMA/CVMP/110264/2020
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Ketoprofen - Summary opinion of the CVMP on the establishment of maximum residue limits (PDF/137.78 KB) (new)

Adopted
First published: 20/03/2020
EMA/CVMP/111083/2020
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Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020

CVMP, Last updated: 20/03/2020
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020 (PDF/155.97 KB) (new)

First published: 20/03/2020
EMA/CVMP/120715/2020
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020 (PDF/155.97 KB) (new)

First published: 20/03/2020
EMA/CVMP/120715/2020
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Press release: EMA Management Board – highlights of March 2020 meeting

MB, Last updated: 20/03/2020
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EMA Management Board – highlights of March 2020 meeting (PDF/135.9 KB) (new)

First published: 20/03/2020
EMA/126753/2020
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Notice to stakeholders - Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products (PDF/620.01 KB) (new)

First published: 19/03/2020
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Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19 (PDF/109.91 KB) (new)

Adopted
First published: 19/03/2020
EMA/134143/2020

11191 results

Rabitec-V-C-004387-II-0002 : EPAR - Assessment report - Variation (PDF/294.31 KB) (new)

Rabitec : EPAR - Procedural steps taken and scientific information after authorisation (PDF/109.38 KB) (new)

Minutes of the CVMP meeting of 18-20 February 2020 (PDF/268.14 KB) (new)

News: Regulatory information - 1.6% increase in fees from 1 April 2020

Council Regulation (EC) No 297/95 as amended by Commission Regulation (EU) 2020/422 of 19 March 2020 adjusting the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020 (PDF/506.65 KB) (new)

Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2020 (PDF/888.69 KB) (new)

EMA Regulatory Science to 2025 - Strategic reflection (PDF/4.8 MB) (new)

Press release: Advancing regulatory science in the EU – new strategy adopted

Analysis and summaries of public consultation results: EMA Regulatory Science to 2025 - Strategic reflection (PDF/1005.11 KB) (updated)

Advancing regulatory science in the EU – new strategy adopted (PDF/102.51 KB) (new)

News: EMA to issue electronic certificates for medicines

10-year annual report on MUMS/limited market scheme for veterinary medicines (PDF/2.08 MB) (new)

News: Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species

Summary of transfers of appropriations in budget 2019 - Issues for consideration - Management Board meeting of 19 March 2020 (PDF/147.41 KB) (new)

Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2020 (PDF/453.48 KB) (new)

Outcome of written procedures finalised during the period from 23 November 2019 to 20 February 2020 (PDF/149.37 KB) (new)

CVMP summary of positive opinion for Lydaxx (PDF/61.75 KB) (new)

Ketoprofen - Summary opinion of the CVMP on the establishment of maximum residue limits (PDF/137.78 KB) (new)

Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020 (PDF/155.97 KB) (new)

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020 (PDF/155.97 KB) (new)

Press release: EMA Management Board – highlights of March 2020 meeting

EMA Management Board – highlights of March 2020 meeting (PDF/135.9 KB) (new)

Notice to stakeholders - Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products (PDF/620.01 KB) (new)

Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19 (PDF/109.91 KB) (new)