All Brexit articles
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FocusProcedure withdrawals within Europe: past trends, impact and communication recommendations
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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JournalBrexit: The regulatory landscape one year on
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.
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FocusRegulating medicines in a surge of change
RegRap speaks to Steve Hoare, Quality Regulatory Science and Safety Policy Director at the ABPI
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FocusThe impact of the Northern Ireland Protocol on human medicines
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 ...
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FocusBrexit − Regulatory and supply chain considerations
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 ...
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FocusPharmacovigilance regulations post-Brexit
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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InterviewA strong advocate for global harmonisation in animal health
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.
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FocusClinical Trial Information System: overview, opportunities and challenges
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 ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.