The Medicines and Healthcare products Regulatory Agency (MHRA) is making preparations to ensure that you can continue to submit regulatory and notification information to the UK.
In a no-deal Brexit, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA.
We have a contingency programme in place to deliver new systems and processes should we lose access to the current EU IT systems. Where feasible, we are trying to minimise additional administrative burdens and are trying to make any changes as simple to use as possible.
This webinar replaces the earlier ‘Making submissions’ webinar and is relevant for:
all pharmaceutical companies involved in making medicines regulatory submissions
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
brokers of medicinal products
The content covers how to navigate around MHRA Submissions and outlines the steps involved in submitting regulatory notifications via MHRA Submissions.
The content is designed to help with preparedness and addresses queries raised during the session. The processes and screenshots provided in this webinar are subject to minor changes prior to Day One. From Day One, please refer to the detailed and finalised guidance materials found in Making submissions to the MHRA in a no deal scenario.
Vigilance: MHRA Gateway and ICSR Submissions - webinar
all pharmaceutical companies responsible for submitting Individual Case Study Reports (ICSRs)
all medicines clinical trial sponsors responsible for submitting Suspected Unexpected Serious Adverse Reactions (SUSARs)
The webinar content covers the steps involved in registering and setting up access to the MHRA Gateway. It also covers how to register for the ICSR Submissions solution for companies who will not be using the MHRA Gateway option.
How to gain access to the MHRA submissions portal - webinar
all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
all clinical trial sponsors wishing to submit clinical trial applications to the Agency
brokers of medicinal products
The content covers the steps involved in gaining access to the MHRA submissions portal, the critical role of the initial company administrator and guidance on how to manage access to third party consultants/consultancies who submit on your behalf.
Please note that the systems and processes outlined are subject to change.
Updated page title and summary to clarify who the webinars are for. The rest of the page has not changed.
Added details about recent 'Making submissions via MHRA Submissions' webinar, which replaces an earlier webinar. The new content includes a link to a recording of the webinar and an updated powerpoint presentation.
Added a new link to a webinar on MHRA Gateway and ICSR Submissions.
Information added on how to gain access to the MHRA submissions portal webinar once it's launched - including link to a webinar.