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:

 

• The UK will continue to accept batch testing of medicines carried out in EU and EEA countries, including Investigational Medicinal Products (substances being used in medical trials) manufactured in EU and EEA states.

 

• For medicines manufactured in the UK, the UK will continue to require a UK-based QP to certify the batch testing.

 

• The MHRA is planning a consultation in early autumn, which will consider the future regulation of medicines, medical devices and clinical trials. A more comprehensive technical notice covering the life sciences sector will follow after the consultation.

 

• Marketing Authorisations (MA) of Centrally Authorised Products will automatically be converted into UK MAs, with the MHRA writing to all MAHs to inform them of the conversion process and to provide them with the opportunity to opt out of receiving a UK MA.

 

• New MA applications after Brexit will need to be submitted to the MHRA and will go through a national assessment procedure, meaning that there will be duplication of applications to the EMA and MHRA.

 

• The notices suggest that the MHRA will take a “streamlined approach” to approving MA applications that will place “no greater burden on industry and ensures that patients can access new and innovative medicines at the same time as EU patients.”

 

• The MHRA will consult on a“UK approach to the regulation of orphan medicines, including on incentives to encourage such medicines onto the UK market.”

 

• EU procedures (including mutual recognition, decentralised and centralised procedures) that have not reached the decision phase at the time that the UK exits the EU, will not be valid in the UK. However, the MHRA will take the subsequent EU decisions into account where possible.

 

• For a time-limited period, the UK will continue to recognise CE marking on medical devices. Should this change, the UK will allow adequate time for businesses to implement any new requirements.

 

• The UK will comply with all key elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulations (IVDR), which will apply in the EU from May 2020 and 2022 respectively. However, the new EU Clinical Trials Regulation (CTR) will not be incorporated into UK law. Although, the UK will align where possible with the CTR when it does come into force in the EU, subject to parliamentary approvals.

 

• UK MAHs will be required to submit pharmacovigilance data directly to the MHRA.

Source: Specialised Healthcare Alliance (SHCA)