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Highlights of the December 2018 Management Board meeting
Highlights of the December 2018 Management Board meeting
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Highlights of the December 2018 Management Board meeting
Highlights of the December 2018 Management Board meeting
EMA’s Management Board is updated on the Agency’s preparations for 2019, a year of transition for EMA.
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Revision of guideline on environmental risk assessment of medicines
Revision of guideline on environmental risk assessment of medicines
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Revision of guideline on environmental risk assessment of medicines
Revision of guideline on environmental risk assessment of medicines
EMA has published revised guidance on the assessment of the risk of human medicines for the environment for a six-month public consultation.
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Data from patient registries to replace clinical trials in previously untreated haemophilia patients
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
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Data from patient registries to replace clinical trials in previously untreated haemophilia patients
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
Revised guidelines published on the studies needed to support marketing authorisation applications for certain haemophilia medicines derived from human blood plasma.
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Brexit preparations
Brexit preparations
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Brexit preparations
Brexit preparations
EMA has published detailed guidance to help marketing authorisation holders for both human and veterinary medicines prepare for the United Kingdom’s withdrawal from the European Union in March 2019.
