Making submissions to the MHRA if the UK leaves the EU without a deal

The Medicines and Healthcare Products Regulatory Agency (MHRA) are making preparations to ensure that if the United Kingdom (UK) does leave the European Union (EU) with no deal, companies can continue to submit regulatory and notification information to the UK. Currently the only areas enabled on the MHRA Submissions home page are the User Maintenance and Pharmacovigilance Gateway Management.

Current Eudravigilance Gateway users who would like to gain access to the new MHRA Gateway will need to gain access to MHRA Submissions first. The process for gaining MHRA Gateway access is outlined within MHRA Submissions.

The MHRA have released guidance on user registration, which is the end to end process for adding an initial company administrator, how to add a new user and how to add a new external user. The first person in the organisation to complete the registration process will become the initial company administrator.

When registering an organisation for the first time, a unique email address is required and it is recommended that if you have multiple entities under your organisation, you should appoint an appropriate company administrator to register for each of these entities. For pharmaceutical companies, this relates to the unique 5 digit MHRA company number.

Marketing Authorisation Holders will be able to automatically generate a new Product Licensing (PL) number in MHRA Submissions. The 5 digit number is part of the PL Number, thus the organisation should ensure this legal entity is set up with a company administrator prior to performing the generation of the new PL Number.

To ensure you are able to make submissions to the MHRA from day one, the MHRA recommends beginning the process for gaining access to MHRA Submissions.

To read more on how to gain access to MHRA Submissions, please click here.