Guidance

Webinars: information on how to make submissions to the MHRA

Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products

Submitting via MHRA Submissions portal (PDF, 391KB, 23 pages)

Vigilance - MHRA Gateway & ICSR Submissions (PDF, 261KB, 22 pages)

As part of the Medicines and Healthcare products Regulatory Agency (MHRA) made preparations for Brexit we delivered MHRA Submissions to ensure that you can continue to submit regulatory and notification information to the UK.

Submissions related to human medicines for UK and GB need to be submitted directly to the MHRA. For those regulatory submissions made through European procedures to market in Northern Ireland you will need to submit via the appropriate EU IT systems.

See our detailed guidance on Register to make submissions to the MHRA . Making.

Making submissions via MHRA Submissions - webinar

View our webinar on how to make submissions via MHRA submissions

  • 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
  • e-cigarette producers
  • 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 submissions process.

Vigilance: MHRA Gateway and ICSR Submissions - webinar

View our webinar on how to register for the MHRA Gateway or ICSR Submissions.

This webinar is relevant for:

  • 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

View our webinar on how to gain access to the MHRA submissions portal.

This webinar is relevant for:

  • 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
  • e-cigarette producers
  • 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.

The systems and processes outlined are subject to change.

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. You can also email submissions@mhra.gov.uk with urgent questions. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020