On 23rd June 2016, UK citizens voted in a referendum to decide on whether the UK should continue to be part of the European Union (EU). The result of the vote was in favour of the UK leaving the EU. The next step in withdrawing from the EU is for the UK government to invoke Article 50 of the Lisbon Treaty. It is not clear exactly when this will done but it is expected to be later this year. Once Article 50 has been invoked there will be a long period of negotiation which will see up to 2 years during which the existing systems will continue to be in place. We don’t expect very much to change concerning pharmaceutical regulation during this period. It is currently unclear what the longer term impact will be but we think it most likely that the UK, who will remain part of the European Economic Area, will continue to be part of European licencing procedures.
Regulis will continue to provide EU regulatory, pharmacovigilance and quality assurance expertise as it has done for over 15 years. Regulis has an established network of local consultants across Europe that ensures we have and will continue to have, good working relationships with all EU regulatory authorities.
Regulis are closely monitoring the situation to ensure we continue to provide the highest quality regulatory support across the EU and in the UK to both our existing and future clients.
EMA and MHRA statements following the result of the UK referendum can be found via the following links: