MHRA have confirmed that in the event of a no deal Brexit they will be a stand-alone regulator making decisions and functions with a pragmatic approach to current EU standards. They currently have 51 high priority tasks that still need to be implemented for day 1 of a no deal Brexit. So what could this mean for Good Manufacturing Practice? Or even FMD?
Currently, the UK will need to be ready for FMD by February 9th, 2019 and this means that medicines will be commissioned and decommissioned into an EU system called ENVO – but what happens if we leave the EU with a no deal? The answer to this is that the MHRA are considering the implementation of a system similar to the EU system one but have not yet committed to this and offered no timeframe for such a system if it is to be implemented. So the UK will be required to utilise the EU system from February 9th for commissioning and decommissioning medicinal products and then 47 days later be denied access with no immediate, alternative system.
The MHRA have also considered creating a new role in the event of a no deal Brexit. This role is an RPI (Responsible Person – Import), which would have similarities to a QP in that the RPI would be responsible for signing off and ‘batch releasing’ medicinal products for sale that have been imported into the UK from Europe. The RPI will need to have the relevant qualifications and experience, including a degree, and they must be a member of a professional body such as the Royal Society for Chemistry, Royal Pharmaceutical Society, Royal Society of Biology, etc, so again, what does this mean for the current RPs that have years and years of experience but are not part of a registered body?
Unfortunately, there are still a lot of questions surrounding Brexit and medicinal products but the biggest question is, will we be ready to leave the EU on March 29th, 2019 with a no deal Brexit?