EMA and MHRA Preparing for No Deal Brexit



Now that Brexit has been delayed, there is still no guarantee of a deal. The extension will be until April 12 if the withdrawal agreement is not approved by the UK House of Commons by March 29, and until May 22 if it is. During this time, the UK will continue to be a Member State in the EU. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are preparing for the possibility of a no deal Brexit.

How Does Brexit With No Withdrawal Agreement Affect Clinical Trials?



The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.