All Europe articles – Page 2
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JournalThe national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...
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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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Meeting ReportIVD3: EU Implementation: Current State
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…
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JournalKey steps and considerations of the EU centralised procedure
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).
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