All Europe articles – Page 3

  • Brexit supply chain
    Focus

    Brexit − Regulatory and supply chain considerations

    2022-02-23T10:19:00Z

    The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...

  • post brexit
    Focus

    Pharmacovigilance regulations post-Brexit

    2022-02-23T10:06:00Z

    The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...

  • eu
    Meeting Report

    IVD3: EU Implementation: Current State

    2021-11-23T14:30:00Z

    The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…

  • AdobeStock_210414987 (1)
    Journal

    Key steps and considerations of the EU centralised procedure

    2019-07-01T14:19:00Z

    This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).