All Brexit articles

  • AdobeStock_474559629
    Focus

    Procedure withdrawals within Europe: past trends, impact and communication recommendations

    2022-05-18T16:00:00Z

    When an application for a new veterinary medicinal product (VMP) is submitted through a MR/DCP, the Applicant has the option to prematurely withdraw their application in the reference member state (RMS) or in one or several of the concerned member states (CMS). This would result in a total or partial withdrawal of the procedure. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) sent a questionnaire to all national competent authorities…

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    Journal

    Brexit: The regulatory landscape one year on

    2022-03-21T09:37:00Z

    A year since the UK departed from the EU, what has changed? The UK has started to depart from the EU in a number of different ways. This article will explore what has changed, how it came about and what to look out for as the relationship between the UK and EU, as well as the rest of the world, continues to evolve.

  • brexit
    Journal

    March 2022 – Contents

    March 2022  |  Volume 19  |  No.3

  • medicines
    Focus

    Regulating medicines in a surge of change

    2022-02-23T15:41:00Z

    RegRap speaks to Steve Hoare, Quality Regulatory Science and Safety Policy Director at the ABPI

  • brexit 2
    Focus

    The impact of the Northern Ireland Protocol on human medicines

    2022-02-23T13:41:00Z

    Since the UK’s exit from the EU, the pharmaceutical industry has sought guidance on how this would impact the registration and supply of medicines, both in the UK and the EU. In addition, the publication of the Northern Ireland Protocol has added additional complexities, with a major impact on the ...

  • 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) ...

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    Interview

    A strong advocate for global harmonisation in animal health

    2022-02-21T08:52:00Z

    Gavin Hall, Interim Director of Authorisations at the Veterinary Medicines Directorate, discusses the agency’s drive to harmonise scientific guidelines and its readiness to be flexible with regulatory frameworks following Brexit.

  • clinical trial
    Focus

    Clinical Trial Information System: overview, opportunities and challenges

    2021-12-23T09:10:00Z

    The implementation of the Clinical Trial Information System (CTIS), from 31 January 2022, will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications, assessment and supervision of trials, while promoting patient safety and transparency…

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    Meeting Report

    MD2: Global development strategy, which market should you go to first?

    2021-11-23T14:15:00Z

    Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.