EMA, MHRA Post Last-Minute Brexit Information

Regulatory NewsRegulatory News | 31 January 2020 |  By 

On the eve of Brexit, the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released information for drugmakers and medical device companies regarding the transition period and future relationship between the EU and UK.
EMA informs companies that EU pharmaceutical law will continue to apply to the UK through the transition period that will run from 1 February 2020 to 31 December 2020, “meaning that pharmaceutical companies can continue to carry out activities until the end of the year.”
Through the transition period, marketing authorization holders and applicants may remain based in the UK, as can their qualified persons for pharmacovigilance (QPPVs), pharmacovigilance system master files (PSMFs) and quality control testing sites.
EMA reminds marketing authorization holders that they have until the end of the transition period to make any necessary changes to their authorized medicines to ensure they comply with EU law and says it will publish additional updated Brexit-related guidance shortly.
EMA also notes that as of 1 February 2020, “the UK will no longer be able to participate in EU institutions and their decision-making,” and that no UK representatives will participate in EMA scientific meetings, working parties or the agency’s Management Board.
On the medical devices side, MHRA emailed its stakeholders reminding them that the UK will continue to follow EU rules for medical devices, including the Medical Device Regulation which comes into effect on 26 May, through the transition period.
MHRA notes that an EU-based authorized representative will not be required for device makers within the UK and that UK-based notified bodies “will continue to conduct third-party conformity assessments in the UK and the results of these tests will continue to be used and recognized for both the UK and EU markets.”
Information reporting to MHRA for medical devices, including for serious adverse events, will remain unchanged during the transition period, and MHRA says the UK will “continue to report to systems that [it has] access to.”
The EU and UK have agreed to pursue a deal on their future relationship before the end of the transition period, with negotiations slated to begin in early March. While both parties have emphasized a desire to reach an amicable agreement, some observers have expressed concern over whether they will be able to do so in just 10 months.


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