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  1. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · SOCIAL QUESTIONS|health|pharmaceutical industry

    #663518

    IATE #3589775
    próiseas um bainistiú athruithe eisceachtúla Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    exceptional change management process | ECMP
    en
    Definition specific procedure for crucial medicines for treatment of COVID-19 patients in order reduce the risk of shortages or disruption of supply following from manufacturing and/or supply problems, which permits the swift implementation of changes to suppliers and/or manufacturing/control sites necessary to reduce the risks of shortages under certain conditions intended to ensure the quality of the medicinal product, while deferring the full assessment of the variation and under which MAHs will be able to exceptionally source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the marketing authorisation if that is necessary to prevent/mitigate shortages of supplies in the EU. Reference "COM-Terminology Coordination, based on: European Commission. DG SANTE/European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA). 'NOTICE TO STAKEHOLDERS QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC' (19.5.2020). Brussels, 10 April 2020 (Revision 1 – 17 April 2020)"
    Comment The ECMP cannot apply to changes classified as extensions of the marketing authorisation in accordance with Annex I of Commission Regulation (EC) No 1234/2008. In addition, it is only available for changes required to address supply chain/manufacturing challenges resulting from the current pandemic with a view to ensure continuity of supplies. Deviations from the requirements in the marketing authorisation or from GMDP3 (other than aspects intrinsically linked to the changes of suppliers and/or manufacturing/control sites) are excluded from the ECMP.