Registering to Make Submissions to the MHRA from 1 January

The Agency is making preparations to ensure that you can continue to submit Regulatory and notification information to the UK. The steps for gaining MHRA gateway access are contained within MHRA Submissions. Prior to day one, the only areas which will be enabled on the MHRA Submissions home page will be User Maintenance and PV Gateway Management.

You must carefully consider who is best placed in your organisation to be the initial company administrator. A company administrator has the ability to add, edit and disable other users. Unless the organisation is one person only, it is recommended that you have at least one other company administrator.

A company administrator can register multiple companies under their account. A user cannot add other users and can only make submissions for the organisation they are registered to. A user will not see records of submissions made by other users.

It is recommended that if you have multiple legal entities under your organisation, you should appoint an appropriate company administrator to register for these entities. For pharmaceutical companies, this relates to the unique 5-digit MHRA company number. The correct Marketing Authorisation Holder information is contained within the application itself and is not dependent on the drop downs selected.

The MHRA company number is a unique number the MHRA assigns to an organisation. If your organisation has made a submission to the MHRA before, you will find this number on correspondences you have received from us. If you have never submitted to the MHRA before, you will need to be set up as a new company.

Only the initial company administrator will need to complete the full user access process. If you are unaware of who your initial company administrator is, please ask within your company. If you need to reset your password, click the "Can't access your account?" link on the Sign-in screen.

Two short video demos provided in the guidance link cover the MHRA Gateway registration process and ICSR Submissions registration process. On receipt of your registration request, the MHRA will aim to complete your registration within five (5) working days. On sending ICSRS/SUSARs via the MHRA gateway, you will receive an acknowledgement within 48 hours.

From 1 January 2021, Marketing Authorisation Holders (MAHs) will be required to submit ICSRs to the UK directly. If you do not have the capability to send or receive via the MHRA gateway, you can send ICSRs or SUSARs to the MHRA via ICSR Submissions. On receipt of your registration request, the MHRA will aim to complete your registration within five (5) working days.

All UK ICSRs (serious and non-serious) and all non-UK serious ICSRs should be transmitted to the MHRA from 1 January 2021. Cases will be automatically processed by the MHRA system, even if previously received from a different sender. Use the following guidance with regards to ICSR reporting unless communications from the MHRA advise otherwise.

Source: MHRA guideline on Registering to make submissions to the MHRA from 1 January 2021