Guidance

Technical information on what the implementation period means for the life science sector

This document 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.

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

Market access for medicines during the implementation period

Market access will not change during the implementation period.

Firms can continue UK batch release testing and qualified person certification, with this being recognised by the EU and vice versa.

Marketing authorisation holders and qualified persons, and qualified persons for pharmacovigilance can continue to be based in the UK and access EU markets.

Manufacturing and distribution licences will continue to be recognised by the EU and vice versa, as will inspections.

UK based firms can continue to apply for marketing authorisations via either the centralised or decentralised procedure.

Market access for medical devices during the implementation period

CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based manufacturers 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.

EU Mutual Recognition Agreements (MRAs) during the implementation period

We 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.

Licensing and packaging

EU Centralised Procedure Licence during the implementation period

To give businesses, organisations and citizens certainty, common rules will remain in place until the end of the implementation period, meaning businesses will be able to trade on the same terms as now up until the end of 2020.

Therefore, a licence for a Centrally Authorised Product will be valid for the EU, and the UK, during the implementation period.

UK national applications during the implementation period

Applications to the MHRA or to the Veterinary Medicines Directorate (VMD) for UK-only marketing authorisations will not be affected.

Transfer of Centrally Authorised Products to UK licences

The timing of this will depend upon the outcome of negotiations on our future relationship with the EU, which we do not want to pre-judge. Whatever the outcome of negotiations, we will look to be pragmatic and support the sector.

Process for new Market Authorisation Applications (MAAs)

To give businesses, organisations and citizens certainty, common rules will remain in place until the end of the implementation period meaning businesses will be able to trade on the same terms as now up until the end of 2020.

Under the terms of the implementation period, MAAs will take effect in the UK. The UK will be able to participate in the procedure but not as a ‘lead Member State’ and will not have a vote in any decision making. The MHRA and the VMD may attend European Medicines Agency (EMA) and EU committees and any groups where there is a UK interest, or where relevant to the EU. The exact nature of this participation is a matter for further discussion.

Processing licence variations during the implementation period

The arrangements put in place by the EMA, in cooperation with the MHRA and the VMD, mean that variations to any centralised, decentralised or mutually recognised licences will be able to continue unaffected during the implementation period. Variations to UK national licences will also be unaffected by the terms of the implementation period.

Products that have not finished a centrally authorised assessment process at the end of the implementation period

Whether the process for such products will have to start again in the UK after the implementation period will depend upon the outcome of negotiations on our future relationship with the EU. Whatever the outcome of negotiations, we will look to be pragmatic and support industry.

Multi-country packs in the UK during the implementation period

To give businesses, organisations and citizens certainty, common rules will remain in place until the end of the implementation period meaning businesses will be able to trade on the same terms as now up until the end of 2020.

Therefore, multi-country packs containing medicines intended for the EU market, for example, will be valid for the EU, including the UK, during the implementation period.

Batch release and testing

Acceptance of batch release and qualified person testing during the implementation period

During the implementation period, EU access to the UK market (and vice versa) will remain unchanged and on the current terms, so batch release and qualified person testing will be accepted.

Import testing of intermediates during the implementation period

Market access will not change for industry during the implementation period and this includes import testing of intermediates.

UK batch testing release of investigational medicinal products will also be recognised in the EU and vice versa.

Location of qualified person and the qualified person for pharmacovigilance for products during the implementation period

To give businesses, organisations and citizens certainty, common rules will remain in place until the end of the implementation period, meaning businesses will be able to trade on the same terms as now up until the end of 2020.

Therefore, a qualified person and qualified person for pharmacovigilance may continue to be located in the UK during the implementation period.

Location of pharmacovigilance master file during the implementation period

As access to one another’s markets will remain unchanged and on current terms, the pharmacovigilance master file will not need to be located in both the UK and EU during that time.

UK regulatory role

Attending EU and EMA committees during the implementation period

During the implementation period, the MHRA and the VMD may attend EMA and EU committees and any groups where there is a UK interest, or where relevant to the EU. The exact nature of this participation is a matter for further discussion.

Accepting the decisions of EU committees during the implementation period

During the implementation period, the UK will continue to respect the decisions reached by the various EU committees regarding the regulation of medicines and medical devices. As set out above, the MHRA and the VMD may continue to participate in all discussions that are relevant to the UK. The exact nature of this participation is a matter for further discussion.

MHRA and VMD access to EU systems during the implementation period

During the implementation period industry would be able to continue to submit information to the MHRA and the VMD using the existing submission routes. The UK will continue to access all EU databases and systems that we currently have today.

UK ‘not acting as leading authority’

Article 123 of the draft Withdrawal Agreement states that “During the transition period, the United Kingdom shall not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States acting jointly referred to in the acts/provisions listed in Annex y+6”.

A “leading authority” conducts assessments on behalf of specific EU agencies. The UK and EU are still discussing the scope of activity that this article will cover with respect to medicines. It does not cover medical devices.

UK authorities will remain available to provide expert advice during this period, and UK businesses will have the same rights during the implementation period as EU-based businesses to have their cases accepted and processed by EU agencies and EU-based leading authorities.

MHRA and VMD roles with the EMA during the implementation period

During the implementation period, the MHRA and the VMD may be able to attend EMA and EU committees and any groups where there is a UK interest, or where relevant to the EU. The exact nature of this participation is still a matter for discussion with the EU

The MHRA and the VMD will also carry on discussing issues with EU counterparts and sharing information as now, including continued access to EMA and EC databases and sharing of vigilance data.

Some elements of the MHRA’s and the VMD’s role will change. For example, the UK will no longer have voting rights in EMA and EU committees.

Other points regarding the transition into the implementation period - medicines

Submitting an application using the UK as the Reference Member State (RMS)

While the UK remains a Member State of the EU it is willing to act as RMS in future Marketing Authorisation (MA) applications. However, the applicant will wish to be aware of certain conditions that the UK and EU have agreed under the terms of the draft Withdrawal Agreement. Subject to ratification, this agreement will provide continued UK participation in the decentralised and mutual recognition licensing procedures, but exclude the possibility of UK acting as RMS in these procedures for approval of marketing authorisations.

The Coordination Groups for Mutual Recognition and Decentralised Procedures – Human and Veterinary (CMDh & CMDv) have also confirmed their current position that transfer of an RMS shall not be permitted before an MA application procedure is concluded.

Applicants will therefore need to take into account whether their application will be concluded before the terms of the draft Withdrawal Agreement take effect.

Applicant part-way through an application in which the UK is the RMS

Given the points listed above, applicants that wish to ensure that procedures involving the UK as RMS will be completed by 29 March 2019 are requested to submit responses to outstanding lists of questions as soon as possible.

Decentralised procedure that will not be finalised before 29 March 2019

If the withdrawal agreement is ratified the UK will still be part of the European licensing processes during the implementation period, and as such we will not be able to accept a separate national application for the same product. In the unlikely event of the withdrawal agreement not being ratified, the UK will complete the assessment of MA applications that have already been submitted to the MHRA or to the VMD.

Submission requirements for filing new applications in 2019/20

If the withdrawal agreement is ratified, the submission requirements for UK applications will remain the same as they are prior to 29 March 2019, through to December 2020. If the agreement is not ratified, the UK will continue to apply the same standards of safety, quality and efficacy for national submissions as it expects today. The content of modules 2-5 of the dossier (or Parts II to IV of veterinary submissions) will be unchanged, with UK specific requirements for module 1 (or Part 1 for veterinary submissions). Further information on UK specific requirements will be made in due course.

UK labelling requirements

During the implementation period the UK will not diverge from current labelling requirements.

UK application of existing MRL requirements (This point is not applicable to the human medicines sector)

During the implementation period the UK will continue to apply the rules and requirements of the MRL legislation, with applicants for products indicated for use in food producing species will need to consider consumer safety and to set withdrawal periods. The statutory withdrawal periods required under the prescribing cascade will continue to apply.

The EU’s new Clinical Trials Regulation (CTR)

(This point is not applicable to the veterinary sector)

The 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, in order that researchers conducting clinical trials can plan with greater certainty.

The two key elements of the Regulation that the UK would not be able to implement on its own after this time are the use of a shared central IT portal and participation in the single assessment model, both of which would require a negotiated UK/EU agreement regarding UK involvement following the end of the implementation period.

We cannot pre-empt the outcome of these negotiations, but the Government has always been clear on its preference for close cooperation with the EU across all aspects of medicines regulations.

The UK’s access to networks, information systems and databases will continue on current terms for the duration of the implementation period.

Regardless of the outcome of 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.

UK’s plans for releasing guidance in relation to the Medical Devices Regulation

(This point is not applicable to the veterinary sector)

We cannot pre-judge the outcome of negotiations which will inform what the future arrangements will be, however, the UK has been central to agreeing the new legislation and we are supportive of its aims to strengthen the regulatory system and increase the transparency of information about products on the EU market.

The EU Medical Devices Regulation will be fully applied from May 2020, during the implementation period agreed with the EU. This would not automatically follow for the new EU Regulations for in vitro diagnostic (IVD) medical devices, which does not apply until May 2022.

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.

Changes to medicines required by the Falsified Medicines Directive (FMD) Delegated Regulation for ‘safety features’, which applies in February 2019

(This point is not applicable to the veterinary sector)

The UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations. When the UK exits the EU, the Withdrawal Act will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the FMD would continue to apply, unless specifically revoked.

*[FMD] Falsified Medicines Directive *[RMS]: Reference Member State *[MA]: Marketing Authorisation *[HRA]: Health Research Authority *[NIHR]: National Institute for Health Research *[MA]: Masters

Published 6 August 2018