Detailed guidance on the electronic submission process for applications to the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has detailed the registration process for submitting applications and reports through national portals.

MHRA Submissions

The guidance begins with information on the process of creating an account. Firstly, one individual within the organisation will complete the registration process and become the initial company administrator. This person can then provide colleagues and external consultants with standard user access to MHRA submissions or add them as additional administrators as required. Note that any third party consultants added must already have a 5 digit MHRA company number.

If an organisation is responsible for multiple legal entities, the MHRA recommend that they appoint an appropriate company administrator to register for each individual entity. For pharmaceutical companies, this relates to the unique 5 digit MHRA company number. This will allow Marketing Authorisation (MA) holders to generate a new Product Licensing (PL) number (including PLGB and PLNI) in the portal. It is for this reason that entities should be registered in order for the PL number to use the correct 5 digit MHRA number which can be selected from a drop down menu.

Vigilance systems

All companies that submit Individual Case Study Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), must do so via the MHRA gateway or ICSR Submissions portal.

The MHRA gateway can be used upon completion of setting up an MHRA Submissions account by selecting ‘Gateway Management’ and following the process in the user reference guide. All serious and non-serious UK reports from the MHRA will be received via the MHRA gateway.

For those unable to use the MHRA gateway, an account can be set up with ICSR Submissions. In the portal, registrants can select the ‘Request company account’ option before completing the process as per the user reference guide. Anonymised Single Patient Reports (ASPRs) for GB reports from the MHRA will be received via ICSR Submissions.

For both systems, all Northern Ireland cases need to be downloaded from EudraVigilance.

Transition between reporting to EU and UK systems

MAHs are now required to submit ICSRs directly to the UK via the vigilance systems previously outlined. Previously, the European Medicines Agency (EMA) forwarded UK ICSRs processed through EudraVigilance on to the MHRA. Any ICSRs processed before 11pm on 31 December 2020 were passed on to the MHRA. To assist companies in any reconciliation required, the MHRA published a list of cases received on 31 December 2020 from the EMA.

To read the full guidance and access all available resources, click here.