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Consultation outcome: MHRA consultation on EU exit no-deal legislative proposals

Medicines Healthcare Products Regulatory Agency

October 9
11:36 2019

We have published updated guidance on the regulation of medicines, medical devices and clinical trials if theres no Brexit deal.

This guidance includes changes based on responses to this consultation.

It is an updated and more comprehensive version of the technical notice on this subject which was published in August 2018.

Original consultation

Summary

This consultation seeks your views on how the Medicines and Healthcare products Regulatory Agencys (MHRA) legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UKs exit, with no Implementation Period. This consultation covers no-deal proposals on medicines, clinical trials and medical devices.

This consultation was held on another website.

This consultation ran from
to

Consultation description

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The UK is exiting the EU on 29 March 2019. The UK and EU negotiating teams have reached agreement on the terms of an implementation period that will start on 30 March 2019 and last until 31 December 2020. We firmly believe it is in the interests of both the EU and the UK to strike a deal. That remains the goal on both sides and we are confident that this will be achieved.

However, a responsible government should prepare for all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached and that is exactly what we are doing, with this consultation forming part of these preparations.

The overall approach in no-deal is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.

Consultation context

We firmly believe it is in the interests of both the EU and the UK to strike a deal. That remains the goal on both sides and we are confident that this will be achieved.

But it is the job of a responsible government to prepare for all scenarios, including the unlikely event that we reach March 2019 without agreeing a deal.

For two years, the government has been implementing a significant programme of work to ensure the UK will be ready for EU Exit in all scenarios, including a potential no deal outcome.

It has always been the case that as we get nearer to March 2019, preparations for a no deal scenario would have to be accelerated. Such an acceleration does not reflect an increased likelihood of a no deal outcome. Rather it is about ensuring our plans are in place in the unlikely scenario that they need to be relied upon.

As part of this, the Government is committed to providing the wider healthcare industry with as much certainty as possible about the UKs preparations for our exit from the EU, under any scenario. The publication of the technical notices, such as those for the life sciences sector, demonstrated this commitment by providing guidance on many aspects of regulation for the life sciences sector in a no deal.

It is also appropriate to consult on some of the key proposed changes to ensure input from industry, allied healthcare professionals, medical charities and the public. This consultation builds on the technical notice How medicines, medical devices and clinical trials would be regulated if theres no Brexit deal. It seeks views on the mechanics behind some of the policies set out in the technical notice, as well as some areas not covered in the technical notice.

Should we not achieve our desired relationship with the EU, the Government will ensure that patients are not disadvantaged by the future regulatory regime. We will establish a regulatory system that continues to protect the interests of patients and strengthens the UK life sciences industry. The UK life sciences industry has much to offer in creating, developing, trialling and commercialising medicines that will benefit UK patients and strengthen the ability of the UK to compete internationally.

In the unlikely event of a no-deal scenario, the MHRA would be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include new innovative licensing routes, the possibility of new global partnerships, and a competitive fee structure.

Whatever the exit scenario, we will continue to ensure that UK patients are able to access the best and most innovative medicines and medical devices and that the

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