Expert insight: medicines and medical device regulatory landscape in post-Brexit UK
The following expert insight piece has been provided by Dr Tasmina Goraya, Partner, Taylor Wessing LLP, as part of our partnership with the N-Site portal.
The UK left the European Union at 11pm on 31 January 2020 and the Implementation Period (also known as the transition period) is due to end at 11pm on 31 December 2020. This means that there will be new rules that will apply to medicines and medical devices in the UK from 1 January 2021.
Most UK laws on medicines and medical devices flow from EU law and most of these are retained in domestic law, subject to changes to amend the domestic legislation that would no longer operate appropriately following the UK’s exit from the EU. However, different sets of rules will apply for Great Britain and Northern Ireland. The effect of the Northern Ireland Protocol, which forms part of the EU-UK Withdrawal Agreement, is that Northern Ireland will remain subject to some EU rules from 1 January 2021 and will benefit from the EU’s single market. Businesses will therefore need to deal with two sets of rules that apply in Great Britain and Northern Ireland.
The UK Medicines and Healthcare products Regulation Agency (MHRA) would remain the regulator for medicines and medical devices in Great Britain and Northern Ireland. It has published a raft of guidance on how the new regulatory landscape may look like from 1 January 2021. This note provides a high-level summary of some of the key areas.
All medicines on the Great Britain market will require a GB marketing authorisation
Granted marketing authorisations (MAs) under the centralised procedure will be automatically converted into Great Britain MAs and issued with a new MA number on 1 January 2021 (though MA Holders can opt out by 21 January 2021). MAs for centrally authorised medicines that are not currently on the EU or UK market can also be converted and the sunset provisions (requiring the product to be marketed within 3 years) will restart on the date of conversion. How the MHRA will handle pending centralised MA applications for Great Britain will depend on the route chosen by the MA applicant and the stage of the application process.
From 1 February 2020, the UK could no longer act as the reference member state under the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP), but could act as the concerned member state during the Implementation Period. The Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published practical guidance on Brexit-related procedures for medicines authorised under the DCP or MRP. The MHRA has also published guidance on MA applications referred under Article 29 of the Medicinal Products Directive (Directive 2001/83/EC), but more guidance is expected.
New UK assessment routes would be available from 1 January 2021
The MHRA has provided an outline of a new UK authorisation system that may become available from 1 January 2021. It has four elements:
- The MHRA is working with partners across the UK healthcare system (including NICE) to develop approaches to reduce time to patient access for new medicines and technologies. A key feature of this would be a new medicine designation.
- A new accelerated assessment procedure that would allow the MHRA to reach an opinion within 150 days of a valid application.
- A new rolling review route that is intended to enhance the development of novel medicines where applicants would have on-going regulatory input and feedback. It would apply to any new active substance, including biologics.
- For two years from 1 January 2021, Great Britain will adopt decisions taken by the European Commission on the approval of new MAs in the community marketing authorisation procedure. The UK will also take into account MA decisions of EU Member States when considering MA applications under the DCP or MRP. Applications for this procedure should be submitted to the MHRA.
A new regime will apply to orphan medicines in Great Britain. The eligibility criteria would be linked to the prevalence of the condition in Great Britain rather than the EU. A Great Britain marketing authorisation with orphan status would benefit from a 10-year market exclusivity period, but market exclusivity periods for centrally authorised orphan medicines that are converted into Great Britain marketing authorisations will continue to apply.
Clinical trials in the UK will require a sponsor or legal representative to be in the UK or on an approved country list (which currently includes the EU/EEA countries). For clinical trials involving sites in the UK and EU/EEA and the sponsor is from the rest of the world and has a UK legal representative, the sponsor would need to assign an EU/EEA legal representative for the EU/EEA sites by submitting a substantial amendment to the relevant EU/EEA competent authorities. In respect of investigational medicinal product (IMP) certification and import, where the holder is required to be included for importation to an ongoing trial site, a substantial amendments should be submitted to the MHRA to include details of the MIA (IMP) holder performing the supply chain oversight within one year of 1 January 2021.
Wholesale dealers in Great Britain may require a Responsible Person (Import) (RPi)
Wholesale dealers in Great Britain would only be able to import Qualified Person (QP) certified medicines from the EEA into Great Britain from 1 January 2021 if certain checks are made by the RPi though there are some products that would not require RPi oversight.
Qualified Person for Pharmacovigilance (QPPV)
The MA Holder of UK nationally authorised products must have permanently and continuously a QPPV at their disposal. The QPPV can reside and operate anywhere in the UK or the EU/EEA. However, if the QPPV does not reside or operate in the UK, there must be a national contact person who resides and operates in the UK as the contact person for pharmacovigilance and reports to the QPPV. The grace period to appoint the national contact person is within 12 months from 1 January 2021. A UK-located QPPV would not be acceptable in EU Member States. Further guidance on the pharmacovigilance procedures can be found here and here.
The Association of British Pharmaceuticals Industries (ABPI) and European Federation of Pharmaceutical Industries and Associations (EFPIA) have asked the UK Government and the EU for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP), which would include batch release and testing that would see both sides accept each other’s tests. The absence of such a mutual recognition agreement could see duplications on both sides of the border which could cause duplication and additional costs.
The new EU Medical Device Regulation (Regulation (EU) 2017/745; MDR) and In Vitro Diagnostic Device Regulation (Regulation EU 2017/746; IVDR) will not apply in Great Britain. However, after 1 January 2021, CE marked medical devices under EU medical device legislation (Medical Device Directives or the new MDR and IVDR) can continue to be placed or put into service in the Great Britain market until 30 June 2023.
Additional rules will also apply from 1 January 2021, including:
- Appointing a UK Responsible Person – A manufacturer established outside of the UK will need to appoint a UK Responsible person established within the UK in order to place a medical device (or put it into service) in Great Britain.
- Registration – All medical devices will need to be registered in Great Britain with the MHRA from 1 January 2021, subject to a grace period:
- 1 May 2021 – Active implantable medical devices, Class III medical devices, Class IIb implantable medical devices, and IVD List A products)
- 1 September 2021 – Other Class IIb and Class IIa medical devices, IVD List B products and self-test IVDs
- 1 January 2022 – Class I medical devices and general IVDs (unless already registered with the MHRA).
A new UK Conformity Assessed (UKCA) marking system would also apply on a voluntary basis from 1 January 2021. Conformity assessment procedures under the new regime would be based on those set out in the three Medical Device Directives (Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC), which are already implemented into UK law under the UK Medical Device Regulation 2002. A UK Approved Body would be needed where the conformity assessment requires the involvement of independent third party (analogous to where a Notified Body under the EU framework is required). The UKCA mark would not be recognised on the EU, EEA or Northern Ireland markets, and will become mandatory for the Great Britain market from 1 July 2023.
For medical devices already on the EU market on 1 January 2021:
- UK Notified Bodies will no longer be competent to carry out conformity assessment for medical devices on the EU market. EU-recognised Notified Bodies are required for medical devices that need to (or have undergone) conformity assessment involving a Notified Body.
- Authorised Representatives based in Great Britain will not be recognised in the EU. Great-Britain based manufacturers and those outside of the EU who use a Great Britain-based Authorised Representative would need to appoint one based in the EU or Northern Ireland.
- EU labelling requirements will need to be met in order to place medical devices on the EU market. Devices for the EU market cannot be dual marked (e.g. UKCA / UKNI mark and CE mark).
The Medicines and Medical Devices Bill will introduce new medical enforcement tools available to the MHRA when it becomes law, including enforcement undertakings and civil monetary penalties.
New rules would apply to the supply of medicines in Northern Ireland from 1 January 2021. However, the UK and EU have agreed a phased process of implementing medicines regulation in Northern Ireland to provide additional time for businesses to prepare in relation to batch testing, importation and the Falsified Medicines Directive requirements. The solution, which would apply for up to 12 months, comprises three elements:
- A temporary removal of the obligation to decommission safety features applied to medicinal products supplied to the UK by a wholesaler in the EU.
- A consideration of small markets historically dependent on medicines supply from or through Great Britain as “justifiable cases” allowing for quality control testing in Great Britain during a limited time.
- An abstention from sanctioning certain breaches of EU law arising due to the absence of manufacturing authorisation holders in Northern Ireland.
CE marking for medical devices under the EU medical device framework will continue to be mandatory in Northern Ireland. A UKNI mark would also be required where (a) medical devices that require mandatory third-party conformity assessment are placed on the Northern Ireland market after 31 December 2020; and (b) a UK Approved Body carried out that conformity assessment. Medical devices co-marked with a CE and UKNI mark will not be accepted on the EU market – those for the EU market must only have a CE mark. There would also be additional requirements flowing from the new UK regime such as registration of medical devices.
Unlike Great Britain, the MDR and IVDR will apply in Northern Ireland from 26 May 2021 and 26 May 2022.
The new rules and different regulatory positions of Great Britain and Northern Ireland will be ironed out in the coming months with the implementation of legislation and more detailed guidance.
Regardless of the outcome of the ongoing negotiations, the UK has a unique ecosystem to support life science businesses and promote innovation and collaboration. The combination of world-leading scientists, together with a highly experienced regulator (the MHRA) and the NHS will continue to make the UK an attractive place for life science businesses post-Brexit.
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