MHRA has issued updated guidance on the regulation of drugs and devices in the UK (GB and NI) following the end of the Brexit Transition Period (31 December 2020). The guidance is separated for GB (England, Wales, Scotland) and NI (N. Ireland); this is primarily because NI will continue to be aligned with and follow EU regulations for drugs and devices.
The guidance covers a wide range of areas including:
- Clinical trials
- Pharmaceuticals / Marketing Authorisations
- Manufacturing and supply
- Medical devices
Whilst further additional and supplementary guidance is expected in the coming weeks and months, there are a number of notable changes to the current regulatory framework that has the potential to impact the supply of drugs and devices to GB patients and users, as well as impacting on manufacturers that supply and sell in the GB market. The following specifically addresses the key changes to the regulation of pharmaceuticals and medical devices, and particularly to currently approved/used products.
- For the most part, the current EU guidance will be copied from EU law into GB law except for some very specific cases related to reference products and comparator products. NI will continue to be part of EU procedures.
- Suppliers of pharmaceutical products must establish a legal presence in GB. Currently, the legal requirement is that all manufacturers must have a legal base in an EU member state. As a result of the MHRA announcements, all non-UK manufacturers must establish an entity in GB. (WBR already provides such services to Chinese clients under the current guidance and will extend this to all non-UK manufacturers)
- Currently, EU CE Marked products are acceptable for supply and sale in GB until June 2023 after which GB specific certification (UKCA) will be mandatory.
- UKCA certification may only be issued by UK Conformity Assessment bodies and the current Notified Body CE marks will not be acceptable.
- Following the end of the Transition Period (31 December 2020), all medical devices supplied to GB must be registered with MHRA. A grace period of up to 8 months will be applied based on the product classification. EU registrations will not be acceptable for GB supplies.
- Similarly, following the end of the Transition Period, The EU Rep role will not be accepted in GB and will be replaced by a UK Responsible Person (UKRP). All non-UK manufacturers of medical devices must appoint a UKRP as a legal representative.
Given that the majority of medicines and medical devices/equipment in the GB market are manufactured and supplied from outside the UK, these changes have the potential to have a significant impact on manufacturers and suppliers as well as patients and users. The three-four month window to the end of the Transition Period and the time up to the end of the eight-month grace period will be challenging to meet given the legal frameworks and responsibilities that will need to be established in order to facilitate the continued supply of healthcare products.
In addition to the impact on currently registered products in the UK, other changes in the regulations will impact clinical studies and the registration of new products. Whilst many of the details are defined, there are elements that are still to be rolled out and it is anticipated that the supply of new medicines and treatments in the UK may be delayed due to additional or different regulatory requirements to those in place in the EU. Woodley BioReg will provide further details as they become available.