101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 135 For human medicines manufactured in a country on the MHRA’s QP list, which have the relevant QP certification, we will continue to recognise certification, release and assurance of compliance with the MA and with GMP guidelines, if conducted by a QP based in the listed country, without the need for any further certification. The approaches to QP certification of licensed medicines set out above will also apply to IMPs. These arrangements will continue until the government considers any further change is necessary. We are committed to working with industry ahead of any such changes to the arrangements outlined in this technical notice which might impact supply chains and manufacturing processes, and to giving at least two years notice of the introduction of any changes, in order to allow industry to fully prepare for their implementation. What you would need to do In the unlikely event of the UK leaving the EU with no deal, there are different implications for the pharmaceutical sector, depending on whether they are selling human medicines onto the UK, EU or EEA market. To ensure continuity of supply in medicines, we would continue to accept batch testing of human medicines done in certain countries included on a list which will be set out by the MHRA. We would apply the same approach to QP certification and release as we do now. The EMA ha s published guidance on its website a s to the approach EU and EEA countries will take to human medicines that are batch tested and certified and released by a UK based QP if there’s no deal.