MHRA releases response to consultation on EU exit no-deal legislative proposals

With the United Kingdom (UK) leaving the European Union (EU) on 29th March 2019, the Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance which outlines the UK’s proposed arrangements for medicine, medical device and clinical trial regulation if the UK leaves the EU with no deal. Read more “MHRA releases response to consultation on EU exit no-deal legislative proposals”

EMA enters third phase of Brexit preparedness business continuity plan

On 1st October 2018, the European Medicines Agency (EMA) entered into the third phase of their Brexit preparedness business continuity plan (BCP). During the third phase, the temporary suspension or decrease in additional activities will enable the EMA to safeguard core activities which are related to the evaluation and supervision of medicines, whilst the Agency acts on the consequences of the United Kingdom’s exit from the European Union (EU) in March 2019. Read more “EMA enters third phase of Brexit preparedness business continuity plan”

MHRA opens consultation on EU exit no-deal legislative and regulatory processes

The Medicines and Healthcare Products Regulatory Agency (MHRA) has opened a consultation on how legislative and regulatory processes would have to be modified in the event of a ‘no deal’ when the United Kingdom (UK) leaves the European Union (EU) in March 2019, with no implementation period. Read more “MHRA opens consultation on EU exit no-deal legislative and regulatory processes”

Submitting regulatory information if there’s no Brexit deal

The Department of Health and Social Care has released guidance to inform Medicines and Healthcare products Regulatory Agency (MHRA) stakeholders of how to continue to submit regulatory information in the event of a ’no-deal’ Brexit scenario. Further guidance on ‘Batch testing medicines if there’s no Brexit deal’ and ‘How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal’ should also be considered. Read more “Submitting regulatory information if there’s no Brexit deal”

EMA releases simplified process for transferring internal marketing authorisations in response to Brexit

The European Medicines Agency (EMA) has released a simplified process for transferring marketing authorisations in response to Brexit. The process applies to companies that would like to move marketing authorisations between organisations registered under the same EudraVigilance (EV) headquarter profile. Read more “EMA releases simplified process for transferring internal marketing authorisations in response to Brexit”

EMA to temporarily scale back and suspend activities as more staff than anticipated quit ahead of Brexit relocation

The European Medicines Agency (EMA) has stated that they will further scale back operations as staff who do not intend to relocate to Amsterdam next year begin to leave the agency. The EMA notes that they expect staff departures to accelerate as the move to Amsterdam in March 2019 approaches. The agency explained that the temporary cuts in activities are necessary because the EMA expects to lose more staff than initially anticipated. Read more “EMA to temporarily scale back and suspend activities as more staff than anticipated quit ahead of Brexit relocation”

EMA hopes to avoid €465 million Brexit bill

The European Medicines Agency (EMA) hopes to avoid the €465 million ($545 million) charge they could incur for the early termination of the contract on their London office. The EMA is tied into the lease of their London office until 2039, however the EMA believes that the opportunity to sublet and the United Kingdom’s (UK) openness to helping with withdrawal costs could spare them from the burden of the early-termination bill. Read more “EMA hopes to avoid €465 million Brexit bill”