The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 with no withdrawal arrangements in place, referred to as a “no deal” scenario.
The guidance updates the MHRA’s technical notice published in August 2018 (see our previous blog on the technical notice) and takes into account the responses to the public consultation in October 2018 on the changes that would be necessary to current UK legislation in the event of a no deal Brexit (see our previous blog on the consultation).
The updated guidance is broadly consistent with the previous position but provides additional details and confirmation on aspects such as the process and timing of marketing authorisation assessments, to help businesses prepare for a possible “no deal”. As well as setting out the key regulatory arrangements that the UK would put in place in the event of a “no deal”, it is noticeable that the updated guidance no longer describes a “no deal” scenario as “unlikely” and instead states that “It has always been the case that as we get nearer to that date, preparations for a no deal scenario would have to be accelerated. We must ensure plans are in place should they need to be relied upon”.
The guidance confirms that in the event of “no deal”, the UK would no longer participate in the EU regulatory networks for medicines or medical devices and the functions currently carried out at EU level for such products on the UK market would be transferred to the MHRA.
The key points in the updated guidance for pharmaceutical and medical device companies are summarised below.
- Existing EU marketing authorisations: The MHRA would automatically grant a separate UK marketing authorisation (MA) for centrally authorised products (CAPs), i.e. medicines with a single marketing authorisation (MA) valid throughout the EU.
- New EU MA applications: New MA applications that have been submitted to the European Medicines Agency (EMA) and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) would undergo a “targeted” accelerated assessment by the MHRA within a timeline of 67 days.
- New active substances: There would be a full accelerated assessment process for new active substances with a timeline of 150 days.
- UK MA process: The MHRA would work towards reducing the current UK national MA assessment timeline from 210 days to 180 days.
- Legal presence: UK MAs would need to be held by an entity located in the UK by the end of 2020. Where the MA holder was not established in the UK initially, a UK contact person for the UK MA would need to be put in place within 4 weeks of exit day.
- Batch testing: The UK would continue to recognise certificates issued by Qualified Persons (QPs) residing in the UK or in an EU/EEA country.
- QPPVs: An EU Qualified Person for Pharmacovigilance (QPPV) could continue to be responsible for UK MAs initially but a UK QPPV would be required by the end of 2020.
- Importing: Holders of a UK wholesale authorisation would be able to purchase medicines that had been QP certified in the EU/EEA provided that they had a designated Responsible Person for Import (RP-I) and could request that the MHRA amend their existing authorisation to include such import activities.
- Packaging/labelling: There would be a grace period until the end of 2021 to update details such as name and address of the MA holder on the packaging and leaflets for products already on the UK market and the UK would continue to accepted packaging and leaflets that included other languages.
- Exclusivity: Data and market exclusivity in the UK would start from the date of the first authorisation in either the UK or EU.
- Orphan products: There would continue to be an orphan designation system for products for rare disease with 10 years market exclusivity based on the current EU criteria but tailored for UK (e.g. based on the prevalence of the disease in the UK population). Orphan designation in the UK would be assessed and granted at the same time as the MA application rather than prior to the MA application as in the EU.
- Parallel imports: Medicines with an MA from an EU or EEA country could continue to be parallel imported to the UK.
- Prescriptions: The UK would continue to recognise valid prescriptions issued in EU or EEA countries.
- Conformity: For a time-limited period, devices that have a CE mark from a Notified Body (NB) based in the UK or an EU country will continue to be recognised by the UK and allowed to be placed on the UK market.
- UK Notified Bodies: UK NBs would be given on-going legal status and certificates issues by them would continue to be recognised by the MHRA.
- Labelling: Labelling requirements would not change and the UK would continue to accept labelling that includes other languages.
- Registration: The current registration requirements (mainly for Class I devices) would be extended so that all classes of medical device would need to be registered with MHRA before being placed on the UK market. If the device manufacturer was not established in the UK, the device would need to be registered by a “UK Responsible Person” in the UK.
- MDR/IVDR: The UK would implement the new EU regulations on medical devices (Regulation (EU) 2017/745) (MDR) and in-vitro diagnostic devices (Regulation (EU) 2017/746) (IVDR) following the same transitional timetable as the EU.
- Clinical investigations: The UK would continue to recognise existing regulatory and ethics approvals for clinical investigations for devices.
- Market surveillance: The MHRA would continue to carry out market surveillance of devices on the UK markets and would be able to take decisions without referring to the position taken across the EU regulatory network.
- Sponsor presence: The sponsor or legal representative of a UK clinical trial would need to be in the UK or EU/EEA.
- UK contact person: The MHRA would continue to refer to the sponsor or investigator(s) responsible for the conduct of the trial at the relevant UK sites and a separate UK contact person would not be required.
- Existing approvals: The UK would continue to recognise existing regulatory and ethics approvals.
- EU CTR: The UK would align with the new EU Clinical Trials Regulation (EU) 536/2014 (CTR) as far as possible.
- IMPs: The UK would recognise QP certification of investigations medicinal product (IMP) from EU/EEA countries.
The guidance also indicates that the MHRA intends to produce further technical guidance notes in the coming months, including on grandfathering of MAs, MA assessment routes, MA change of ownership applications, UK QPPV requirements and the new “Responsible Person for Import” (RP-I) role.
The full guidance can be accessed here.