Regulation & IP
The UK’s withdrawal from the EU will have an impact on the regulation of medicines, medical devices and clinical trials, and the protection of IP.
During the transition period, medicines and devices regulation will stay aligned with the EU from 1 February 2020 until 31 December 2020.
New MHRA guidance issued on 31 January 2020 confirmed that during this transition period:
- Market access will not change
- Pharmaceutical firms can continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa
- Marketing authorisation holders and qualified persons for pharmacovigilance (QPPV) can continue to be based in the UK and access EU markets
- A UK QPPV and Pharmacovigilance System Master File (PSMF) will not be required, as the UK will continue to operate under EU legislation using the EU QPPV and PSMF
- There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)
- Firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures
- The UK can continue to participate in the decentralised and mutual recognition licensing procedures but is excluded from acting as Reference Member State (RMS) in these procedures for approval of marketing authorisations. In addition, the UK cannot act as a rapporteur or co-rapporteur the UK cannot act as a rapporteur or co-rapporteur in the Community Marketing Authorisation procedure
- Community Marketing Authorisations (CMAs) will continue to be valid in the UK and submission routes used in the transition period should be unchanged from those used prior to 31 January 2020. No action is needed in relation to those products for which Product Licence (PL) numbers have already been issued and there is no requirement for a baseline submission to be submitted at this time. If a CMA has been allocated a PL number, do not use the number for any other future marketing authorisation you intend to submit to the UK
- Firms can continue to submit information to the MHRA, using the existing submission routes
- The UK can continue to report to systems that we have access to
MHRA guidance on the transition period also states that:
- The UK will not act as ‘leading authority’ for medicines. A ‘leading authority’ conducts assessments on behalf of specific EU agencies. The UK and EU are still discussing the scope of activity that this will cover with respect to medicines.
- UK authorities will remain available to provide expert advice during this period, and UK businesses will have the same rights during the transition period as EU-based businesses to have their cases accepted and processed by EU agencies and EU-based leading authorities.
- Some elements of the MHRA’s role will change. For example, the UK will no longer have voting rights in the European Medicines Agency (EMA) and EU committees but will continue to respect their decisions regarding regulation of medicines and medical devices.
Guidance from the IPO on IP and Brexit during the transition period
Changes to SPC and patent law if the UK from 1 January 2021
Previous ‘no deal’ guidance
If new arrangements on medicines and devices regulations are not agreed with the EU by 31 December 2020, trade between the UK and EU would revert to WTO rules. This could be equivalent to the ‘no deal’ scenario for which the government provided guidance ahead of 31 October 2019, which is set out in the links below.