MHRA Sets No-Deal Brexit Process for Pharma Submissions
Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU without reaching an agreement by the end of this month.The guidance, posted Monday, describes the steps applicants and sponsors need to follow for access to the new MHRA gateway for UK submissions from day one post-Brexit in a no-deal scenario. It also applies to all current Eudravigilance Gateway users seeking access to the MHRA submissions portal.
In two separate user reference guides, MHRA provides step-by-step guidance on the processes required prior to gaining access to MHRA submissions and managing user or administrator permissions.
The guidance calls on pharmaceutical companies to establish an MHRA account request page—the first step in the process for gaining access to the MHRA portal—to ensure submissions to the UK regulator can be made from day one. Setting up access for multiple legal entities requires a unique email address for first-time registration using a 5-digit MHRA company number. The guidance provides examples of MHRA correspondence in which those with previous UK submissions can find this number.
The guidance was published along with updated MHRA guidance on how to change the ownership from one drug marketing authorization holder to another. The update to this guidance relates to applications’ processing time. MHRA indicated an application will be cancelled and a full fee will apply if there is a lack of response within 10 working days, versus the 14 days specified in the last version of the 2014 guidance.
MHRA also linked to recorded webinars on how to make drug submissions to the UK under a Brexit no-deal in January. Also in January, MHRA offered further guidance on no-deal scenarios. The UK regulator also previously sent a letter to holders of centrally authorized products (CAPs) for updated information on the process to grandfather CAPs into UK marketing authorizations in a no-deal scenario.
A no-deal scenario became increasingly likely in recent months after the UK government’s Brexit agreement with the EU fell through, though a delayed Brexit remains an option.
Making submissions to the MHRA in a no deal scenario
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.