Guidance

What the implementation period means for the life science sector

Published 6 August 2018

This guidance was withdrawn on 31 January 2020

For current information about the transition period see the Transition page.

1. Introduction

At the March European Council, the UK and EU agreed the terms of an implementation period to the end of December 2020. The period will give business in the UK and across the EU time to plan with confidence for life after our withdrawal. Businesses and organisations will be able to operate as now throughout the implementation period.

This update sets out what recent developments, such as agreement on the terms of an implementation period, would mean for the life sciences sector, once finalised as part of the Withdrawal Agreement.

The update does not constitute legal advice and companies should seek independent legal advice dependent on their specific circumstances.

2. Before the implementation period

Before the implementation period begins:

• the UK remains a full member of the European Union and all the rights and obligations of EU membership remain in force. This also means that there has been no change to the legal framework within which we operate. Our domestic implementation of EU law remains in place.

• The Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) will continue to lead work (for example acting as rapporteurs for any ongoing procedures) until the implementation period begins. At the date of the UK’s withdrawal from the EU, the MHRA and the VMD will have worked closely with European regulators to facilitate a transfer to another leading authority, with minimal disruption to firms.

3. During the implementation period

For the life science sector, continued market access, opportunities to attend committees and groups, and ongoing data sharing will ensure that access to medicines and medical devices continues, and patient safety is maintained in both markets.

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

We also reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach. This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

Some elements of the MHRA’s and the VMD’s role will change during the implementation period. For example, for medicines the UK will not have voting rights in EMA and EU committees, and the MHRA and the VMD will not act as a ‘leading authority’ to conduct assessments at the level of the Union or Member States acting jointly that inform decision-making processes. UK businesses will have the same rights during the implementation period as EU-based businesses to have their cases accepted and processed by EU-based ‘leading authorities’.

4. How the implementation period affects upcoming EU regulation

The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period. If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty. Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)

5. Beyond the implementation period

Progress is being made to finalise the Withdrawal Agreement as a whole. We will aim to agree this by October, alongside the framework for our future relationship with the EU. We are confident of a positive outcome from the negotiations with the EU and we will continue to act in the best interests of patients, recognising that this will require continued close cooperation between the EU and the UK.