EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates but only electronically signed and authenticated certificates to maintain EMA’s ability to provide these documents during the COVID-19 pandemic.
The European Council (of EU Heads of State or Government) has been active in its response to the coronavirus crisis. So far it has held three video-conference calls of national leaders on the subject, with a view to seeking to develop a coordinated response both among the Member States and collectively at EU level. This note sketches the context, describes some of the instruments available to the Union, and compares responses to the outbreaks of Ebola in the past and COVID-19 today.
No change to the conditions of use of the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) is needed following a review of the results of a European study of real-world data for these medicines.
In the last ten years, 22 new veterinary medicines for minor uses and minor species (MUMS) have been authorised through the centralised procedure by EMA. This is largely the result of the MUMS/limited market policy for the classification of veterinary medicines established by the Agency in 2009.
Update: due to COVID-19, the event will be held online.
To affect this change, 2000+ pharma leaders (from across Commercial, Marketing / Digital, Medical, Patient Engagement, Market Access, RWE and Clinical) will join healthcare’s brightest innovators at eyeforpharma Barcelona 2020 – where pharma decision-makers come to learn, collaborate and see the future of our industry.