MHRA - Registering to make submissions to the MHRA from 1 January 2021

23rd October 2020

The Agency is making preparations to ensure that you can continue to submit regulatory and notification information to the UK.

For applications that you plan to submit to the UK (for example, a Marketing Authorisation for the UK market), you will need to submit the information through our national portals.

The following groups will need to ensure they follow the steps to gain access to MHRA Submissions, so they can make submissions from 1 January 2021:

• all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
• all medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications and Developmental Safety Update Reports (DSURs)) to the Agency
• e-cigarette producers
• brokers of medicinal products

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