Brexit & animal medicines
Since the UK voted to leave the European Union, AnimalhealthEurope, in partnership with its UK member association NOAH (National Office for Animal Health), have been evaluating the implications of Brexit for the animal medicines industry in Europe and the U.K. The integrated nature of the research, regulation and supply of animal medicines across Europe means that there are significant implications for animal medicines companies and the wider research, regulatory and veterinary communities.
AnimalhealthEurope is working with EU authorities to ensure that there is no disruption to supply of animal medicines after the UK leaves the EU and to ensure pragmatic co-operation in areas such as research, quality control testing, clinical trials, pharmacovigilance and access to talent.
As per the guidance from the European Medicines Agency and European Commission, AnimalhealthEurope member companies have been preparing for a no-deal scenario that removes the UK from the EU medicines regulatory framework with no transition period.
Despite this preparation, a no-deal scenario presents a clear threat of disruption to the supply of animal medicines throughout the EU, including from transport delays at the border with the UK and where the development, manufacture, packaging, safety testing and regulation of the medicine involves the UK in a manner that is no longer recognised by the EU.
The latest Communication from the Commission is a welcome step: It states that marketing authorisation holders who are unable to transfer their batch testing site from the UK to the EU27 by 29 March may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions.