By Parastoo Karoon, Principal Consultant, PAREXEL® Consulting
On 23rd of August 2018 MHRA published guidance on ”How medicine, medical devices and clinical trials would be regulated if there is no Brexit deal”. This guidance came in the form of a “Technical Notice”: https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal
Although Britain’s withdrawal negotiations between the UK and the EU are still ongoing, but as the deadline of March 2019 approaches, the UK regulator MHRA felt that preparations for a ‘no deal’ scenario needs to be accelerated.
MHRA describes “the purpose of this notice is to update businesses on the arrangements that will come into force for human medicines regulation currently subject to EU rules if UK leave the EU on 29 March 2019 with no deal”. The notice to Pharma sector covers a wide range of topics, procedure and regulations; a summary of key points is captured below:
- UK will accept batch testing carried out in EU or EEA countries and countries that have mutual recognition agreement with the EU (eg Japan)
- Existing Mutual Recognition and Decentralized Marketing authorizations (MA) for UK prior to 29 March 2019 will be unaffected as they already hold a national UK MA
- Existing Centralized MAs will automatically be converted into UK MAs on 29 March 2019 through “Grandfathering” process
- New MA application will need to be submitted to the MHRA and will go through a national assessment, but UK will accept the eCTD & follow existing processes
- UK will recognize medical devices approved for the EU market and CE-marked until further notice
- UK will continue accepting the EU Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) until further notice
- UK will unilaterally align to the EU/EEA exhaustion regime for parallel imports of pharmaceuticals until further notice
- As clinical trials are currently managed nationally, UK clinical trial applications will continue to be authorised by the MHRA and ethics committees as they are now. The UK ability to participate in multinational trials will also not change.
- The new EU Clinical Trials Regulation (CTR) will not come to force by March 2019 and will not be automatically incorporated into UK law. However, when CTR comes to force in the EU, were possible UK will align with it without delay
- MHRA will have primary responsibility for the conduct and oversight of all pharmacovigilance activities in relation to UK MAs, certificates of registration and traditional herbal registrations.
- No changes to the data and market exclusivity periods for UK MAs.
- UK will not have access to EU databases and portals (EudraLink, EudraVigilance …etc) MHRA will have a national portal
Some of these measures are temporary remedies to avoid disruption to business continuity, and may change in the future, pending on MHRA consultations. But overall, the content of this Technical Notice shows that on medicines, medical devices and clinical trials the UK is aligning itself very closely to EU rules and regulations. This move from the MHRA can be interpreted as the Agency’s desire to reduce the burden of extra regulatory steps on pharma companies for their UK holdings and have the least possible disruption of medicine supply chain from the EU to UK.
PAREXEL is currently supporting clients in developing Brexit regulatory & supply chain strategies.