The MHRA’s „Technical information on what the implementation period means for the life science sector“, which was published on 06 August 2018, stipulates that:
However, caution is advised, as the MHRA also includes the following disclaimer: “This document does not constitute legal advice and companies should seek independent legal advice dependent on their specific circumstances.”
Perhaps the “Guidance” document is a response to the British Parliament’s recent vote to remain part of the EMA. How the EMA – or rather, the EU Commission – will respond to this request remains to be seen. This point will surely be just one element of many in the negotiations that are to follow.
„EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.”
The difference between the MHRA and EMA press releases echoes the ongoing uncertainty about the outcome of the Brexit negotiations. We will be happy to help you evaluate which strategy is right for your company. Get in touch with us!