FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

MHRA Outlines Submissions Process in Case of No-Deal Brexit

March 12, 2019
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The UK’s Medicines and Health products Agency (MHRA) outlined in a new guidance how drugmakers and clinical trial sponsors can access the new MHRA gateway for UK submissions in case of a no-deal Brexit.

Drugmakers should establish an MHRA account request page to ensure they can make submissions to the regulator immediately, the agency said.

First-time registrants for access for multiple legal entities will need a five-digit MHRA company number, with the guidance providing examples of where to find the number for drugmakers with previous UK submissions.

“However, it is recognized that larger organizations may have a significant number of legal entities and setting up individual company administrators for each 5-digit number would be complex and time consuming,” the guidance states.

MHRA has also updated its guidance on the process for changing ownership between drug marketing authorization holders. The updated guidance shortens the timeline for lack of response to an application before the application is cancelled and a full fee applies, from 14 days to 10 days.

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