As you may be aware, the Government has today published its first tranche of 24 notices in relation to a no deal Brexit scenario and supporting guidance, with a further 60 documents due to be published in the coming weeks.
A summary of the relevant guidance is included below. (It’s worth noting that the EU has already published 68 Brexit preparedness notices earlier this year, including on medicinal products for human use.)
As well as the no deal technical notices, the Department of Health and Social Care (DHSC) has published a letter from Matt Hancock to Marketing Authorisation Holders (MAH) setting out the steps they need to take to mitigate disruption caused by a no deal Brexit.
Within this letter, the DHSC has advised MAHs to increase their stockpile of medicines by an additional six weeks supply on top of their own normal stock levels to avoid disruption after Brexit. Moreover, the DHSC is asking suppliers “to ensure they have plans in place to air freight products to avoid any border delays”.
In a separate letter addressed to NHS organisations, Matt Hancock has advised that “hospitals, GPs and community pharmacies do not need to take any steps to stockpile additional medicines”.
Of particular interest to the SHCA, there are three key technical notices that relate to pharmaceuticals and life sciences included in the first tranche.
These are: ‘Batch testing of medicines’; ‘How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal’; and, ‘Submitting regulatory information on medical products if there’s no Brexit deal’.
In line with what we have shared previously, the headlines from these notices are:
Source: Specialised Healthcare Alliance (SHCA)