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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.

Roche’s spinal muscular atrophy therapy Evrysdi approved by EC for newborns

Roche’s spinal muscular atrophy therapy Evrysdi approved by EC for newborns

The EC’s decision to extend the EU marketing authorisation for the therapy follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by an

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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

    Lundbeck filed a marketing authorisation application for Selincro in the EU with European Medicines Agency and a decision is expected later this year.

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

    Activities requiring an EU presence include:. Holding a national or an EU Marketing Authorisation. ... Regulatory as a function has, in the past, been seen as the 'police' that says “no” to commercial and marketing plans.

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