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EU marketing authorisation

This page shows the latest EU marketing authorisation news and features for those working in and with pharma, biotech and healthcare.

EU announces agreement with Gilead for remdesivir supply

EU announces agreement with Gilead for remdesivir supply

Drug was granted conditional marketing authorisation in the EU in July. ... The JPA replaces the initial deal funded by the EU’s emergency support instrument that ran from August through to October 2020.

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  • Brexit implications for UK pharma legislation Brexit implications for UK pharma legislation

    require a significant increase in resourcing, met (mostly) by fees for assessing marketing authorisation applications and other services. ... Companies must be established in the EU to hold an EU/EEA marketing authorisation, and exports from the UK would

  • Shoring up the framework Shoring up the framework

    Marketing authorisation holders for medicines, including orphan drugs, must be established in the EU or EEA. ... So for centrally authorised products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation

  • Pharma deals during September 2012 Pharma deals during September 2012

    Biotie will receive additional sales milestones on achievement of undisclosed sales target in Japan, increasing total reward to 89m ($120m). Lundbeck filed a marketing authorisation application for Selincro in the EU

  • Best practice in regulatory outsourcing: top tips Best practice in regulatory outsourcing: top tips

    Holding a national or an EU Marketing Authorisation. Distribution that requires a licence (a Wholesale Dealers Licence and the services of a Responsible Person in the UK). ... Regulatory as a function has, in the past, been seen as the 'police' that says

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