On September 1, 2020, the UK’s medicines and medical devices regulator released the MHRA post-transition information, an extensive suite of guidance on the UK regulatory regime post the Transition Period expiring on December 31, 2020. The new guidance spreads out across dozens of documents covering the following topics: Clinical trialsDevicesLicensingImporting…

In a letter dated November 6, 2019, Steve Oldfield, Chief Commercial Officer at the Department of Health and Social Care (DHSC), expresses gratitude to the industry for the high levels of preparation ahead of the October 31, 2019, Brexit deadline. However, he states that the multi-layered approach put in place…

As currently reported in our Brexit Blog, one of the first and most visible consequences of Brexit was EMA’s relocation to the Netherlands. EMA’s seat formally changed from London to Amsterdam on March 30, 2019, but preparatory work for the move started well before that date. From the moment the…

The duty of continuous supply by healthcare manufacturers will continue to apply in the UK following a departure of the UK from the EU without a withdrawal agreement. However, with the risk of interruptions to trade with the EU, the UK government has implemented some additional instructions to ensure that…