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EMA released Practical Guidance for Brexit and Market Authorisation Holders

European Union - December 20 2017 The European Medicines Agency (“EMA”) has released a Practical Guidance concerning the steps that centralised Market Authorisation Holders (“MAH”)...

Helen Kimberley, Elisabethann Wright.

EMA launched improved version of EudraVigilance

European Union - December 12 2017 The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and...

Elisabethann Wright.

Publication of the notified bodies’ designation codes under the MDR and IVDR

European Union - December 7 2017 The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical...

Elisabethann Wright, Fabien Roy.

CAMD released roadmap concerning the priorities for the implementation of the MDR and IVDR

European Union - November 23 2017 The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”)...

Fabien Roy.

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

Switzerland - October 16 2017 On 1 October 2017, the Swiss Agency for therapeutic products ("Swissmedic") updated its guidance document concerning the Fast-Track authorisation...

Elisabethann Wright.