The Medicines & Healthcare products Regulatory Agency (MHRA) have released further guidance on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal.
In relation to medicines:
- The transitional provision in legislation will ensure that all currently granted Centrally Authorised Products (CAPs) automatically become UK MAs on exit day, although the holders will have a short period of time after exit day within which to opt out of having a United Kingdom (UK) Market Authorisation (MA).
- MAHs will have 1 year from exit day to provide the MHRA with baseline data for CAPs that are converted into UK MAs.
- In the event of no deal, the MHRA will take decisions on paediatric matters post Exit. Compliance with a UK PIP or waiver should be demonstrated in applications for new medicinal products, as well as in new indications, new routes of administration, and new pharmaceutical forms for all products with supplementary patent protection. The same rewards for PIP compliance would be available – a 6-month extension of a UK Supplementary Protection Certificate (SPC) (an SPC extends patent protection for medicinal products), as well as 2 years’ additional market exclusivity for orphan products complying with a PIP. A UK SPC will be awarded in the UK on the same basis as it is currently granted under EU legislation.
- A MAH should be established in the UK by the end of 2020.
- A Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one. However, a temporary exemption will allow companies until the end of 2020 to do so. This temporary exemption will allow an EU QPPV to assume responsibility for UK MAs until a QPPV who resides and operates in the UK can be established.
- In respect of a manufacturing license, a Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from a country not on an approved country list (which will include all EU and EEA countries from Day 1) must reside and operate in the UK.
- The MHRA will give industry until the end of 2021 to amend certain administrative details on the packaging and in the package leaflets for a product already on the market
In relation to Medical Devices:
- If there is a no-deal Brexit, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market that are currently undertaken through the EU system.
- To support the continuity of supply of products to the UK market, the MHRA will give UK-based NBs an ongoing legal status and continue to recognise the validity of certificates that they issued prior to exit day. This will allow products covered by certificates issued by UK-based notified bodies to continue to be placed on the UK market after exit day.
- The UK will continue to recognise existing clinical investigation approvals – both for regulatory and ethics approvals – and there will be no need to re-apply. UK clinical investigation applications will continue to be authorised by the MHRA and ethics committees as they are presently.
New EU regulations:
- Through the no deal statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place on 1 November 2019, which will mirror all the key elements contained in Regulations 2017/745 on medical devices (MDR)
- After exit day, all medical devices will need to be registered with the MHRA prior to being placed on the UK market. Given this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process as set out below:
– 4 months Class III, Class IIb implantable, Active implantable
– 8 months Class IIb non-implantable, Class IIa
– 12 months Class I
In relation to Clinical Trials of investigational medicinal products:
- The UK will continue to recognise existing approvals – both for regulatory and ethics approvals – and there will be no need to re-apply
Location of trial sponsor:
- The UK would require the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list which would initially include EU/EEA countries.
Regulatory requirements for running a trial:
- The UK’s current regulatory framework, as per the 2004 Regulations, will remain in force after a no deal
Regulatory requirements for Investigational Medicinal Product (IMP) for trials:
- For IMPs coming into the UK, the UK will recognise QP certification done in an approved country (which would initially include all EU/EEA countries).
- All importers of IMPs into the UK will require a Manufacturers License (MIA). The IMP supply chain from EEA states will allow direct supply to clinical investigator sites. For IMPs coming from countries on the approved country list the MIA(IMP) holder will be required to put in place an assurance system to check these IMPs have been QP certified in the EU or EEA.
If you would like to discuss any specific requirements relating to Brexit readiness and how MIAS Pharma can help you, get in touch with us today at firstname.lastname@example.org or call us on +353 (1) 846 3605.