No Deal Brexit Planning – What We Know So Far
The ongoing coverage of the UK’s moves towards leaving the European Union continues. This is a difficult time for companies in the life science sector in the UK and outside of the UK as they work to ensure that patients will be able to access medicinal products and devices when the UK finally departs, as is expected on October 31st. the likelihood of departing in a no deal Brexit scenario has now exacerbated and companies are best served by preparing for such an outcome.
In August 2018, the UK Government (led at the time by Prime Minister Theresa May) released a range of documents detailing how the UK might handle a no deal scenario.
Here is an overview of the proposals made in the no deal documents:
New Submission Portal for the MHRA
Firstly, the UK is in the process of developing its own submission portal, to be used in the event of no deal Brexit.
The following types of information would be submitted via a new national portal:
- marketing authorisation (MA) applications
- periodic safety update reports (PSURs)
- paediatric investigation plans (PIPs)
- clinical trial applications
- qualified person for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) notifications
- individual case safety reports (ICSRs) and subsequent transmission of anonymised single patient reports (ASPRs)
- device registration
- e-cigarette notifications
Submissions to be made to the EU and UK, in the event of no deal, will need to be made separately through EU systems and the above referenced UK portal.
In an effort to avoid confusion the UK would continue to accept EU application forms and EU standards for submission, where possible. The UK would continue to accept the eCTD (electronic common technical document) for submission of regulatory documents relating to an MA. The UK also would avoid unnecessary complexity, for example by following existing processes.
In the event of a no deal Brexit, the UK would cease to be a member of the EMA. The MHRA would take on the functions of the EMA in the UK market. The MHRA is planning a public consultation in late 2018 on some of the legislative changes that would be required should the UK no longer be a member of the EMA.
Let’s take a look at how a no-deal Brexit would impact on the pharmaceutical and medical device sectors.
Pharmaceutical – Implications of No Deal
Converting CAP’s to UK MAs
“Most medicines on the UK market already have a UK Marketing Authorisation (MA), and this will be unaffected by exit from the EU. However, most new medicines come to market via a licencing route overseen by the EMA. These are collectively known as Centrally Authorised Products (CAPs)”.
To ensure such medicines will continue to be authorised for use in the UK, all CAP MAs will automatically be converted into UK MAs on 29 March 2019. MHRA will write to all CAP Marketing Authorisation Holders (MAHs) prior to 29 March 2019 to inform them of the conversion process (known as “grandfathering”) and to provide them with the opportunity to opt out of receiving a UK MA”.
Initial MA Applications
MA applications would need to be submitted to the MHRA and will go through a national assessment.
Mutual Recognition Procedures and Decentralised Procedures
Existing medicines that received a MA for the UK via the MR or DC routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA.
In-progress licensing procedures at time of exit
The document issued in August 2018 by DExEU states “If there’s ‘no deal’, the outcome of 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 EU decisions into account where possible.
For centralised procedures in progress at time of EU exit:
- The application, as submitted to the EMA, will need to be submitted to the MHRA
- If the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion by exit day, MHRA will make its decision taking into account the CHMP opinion
- If not yet at the opinion phase, the MHRA will continue to assess the application as a national procedure. MHRA will take into account any CHMP assessment that had already taken place”.
‘Generic’ MAs – reference products
- The MHRA will not have access to the data provided in support of EU approved products. Therefore, new generic applications would need to be based on reference products that have been authorised in the UK
Existing MAs for generic products that are based on a reference product authorised in the EU would remain valid.
Legal presence requirements
This is an issue that has arisen on numerous occasions in discussions with our clients.
Again, quoting today’s document:
“At present, the MHRA requires a named individual who can be contacted in the event of a safety issue, and has the ability to require independent re-testing of medicines and also the ability to withdraw a product from the market. This will continue if there’s no deal.
The requirement for this would include:
- a MAH should be established in the UK by the end of 2020. Until then, the MHRA will require a contact in the UK. A Change of Ownership will need to be submitted to MHRA to change from an EU MAH to a UK MAH for UK MAs.
- the Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one, although those without a current UK presence will have until the end of 2020 at the latest to do so, but would nevertheless be required to make arrangements for providing the MHRA with access to the relevant safety data related to UK Marketing Authorisations (MAs) at any time. Companies may choose to have the EU QPPV take on responsibility for UK MAs until the UK QPPV can be established. A variation should be submitted to the MHRA to change QPPV. Exact details of this will be consulted upon
- a Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from outside a country on a designated country list (whitelist) must reside and operate in the UK. A QP for products manufactured in a country on a whitelist or manufactured in a third country and imported into the UK from a country on a whitelist can reside in a country on the whitelist”.
Packaging and leaflets
The MHRA has said today that it would be pragmatic in its acceptance of leaflets in the English language as long as they comply with UK legislation.
Devices – Implications of No Deal Brexit
For a limited time, the UK would accept CE marked EU approved devices. The MHRA has advised that it will be carrying out a public consultation on the issue to look at how the UK might introduce its own equivalent of CE Marking as the UK moves away from reliance on EU structures.
UK-based Notified Bodies would, in a ‘no-deal Brexit’ scenario, no longer be able to assess the conformity of medical devices for devices to receive the CE mark and enter the EU market.
Therefore, the MHRA will no longer be able to oversee Notified Bodies in the way that it does now.
The UK’s MHRA will continue to provide UK post market surveillance of medical devices and it would be in a position to decide on the marketing of any device within the UK.
For further details read the full document, published in August 2018, from the DExEU here. This is an ongoing situation and we will endeavour to keep client companies and website visitors up to date with developments.
If you would like to talk to us about any Brexit related queries that your business might have then contact us by completing the form below.