The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached on a transitional arrangement to soft en the impact of Brexit. The European Commission and the European Medicines Agency (EMA) have taken a strict position on Brexit, considering the UK to be a third country from 30 March 2019, as reflected in the Q&A document published in its third version in June 2018. This article spells out the impact of that scenario on the pharmaceutical supply chain and pharmacovigilance, but also looks at the more positive scenario – namely in case the draft “Withdrawal Agreement” is ratifi ed by the UK and EU in time for Brexit. In the “hard Brexit” scenario, companies need to have transferred licences in due time, have adapted their supply chains and processes and have re-located pharmacovigilance operations and persons.
In the case of a transitional regime where EU law continues to apply (“soft Brexit”), no such drastic measures may be necessary. However, the continued uncertainty means that – to some degree – hard Brexit has already happened for the pharmaceutical industry in Europe.
Susan Salako, Regulatory Scientist
Definition and implementation of regulatory strategies and roadmaps for innovative drugs, biologics and ATMPs to foster existing regulatory incentives in order to reduce time to approval and to initiate early dialogue with regulators and payers.Preparation of clinical trial application packages to Competent Authorities in EU countries (DE, UK, ES, IT, FR).
Peter Embley, Senior Director Regulatory Sciences
Peter brings over 19 years applied industrial and commercial biopharmaceutical experience to his role, including seventeen years in Regulatory Science; working within the Generic, R&D and CRO industries. Peter has a strong grounding in EU legislation and filing strategies and has developed both regional and global strategic perspectives coupled with commercial acumen and experience working within multicultural project teams.