Following the end of the Brexit transition period in January, submissions relating to Clinical Trial Authorisations and Marketing Authorisations in the UK will need to be submitted via MHRA Submissions Portal, not CESP.
MHRA Submissions First Step
The first step is to register – each pharmaceutical company responsible for submissions to MHRA should complete user registration. The person to complete the registration will become the company administrator and they can assign additional administrators and users as required. It is important to note that Clinical Research Organisations (CRO) and consultancies, that might manage submissions on behalf of pharmaceutical companies, will have to be added as a user and/or administrator by the pharmaceutical company in order to continue to make submissions on their behalf. The CROs 5 digit MHRA company number will be required to do this.
This new MHRA submissions portal will also apply to submissions relating to e-cigarettes, brokers of medicinal products and Active Substance Master Files (ASMF) holders, so these activities will also require registration and access to MHRA Submissions. Access to the MHRA Gateway for pharmacovigilance activities is also via MHRA Submissions registration.
MHRA Submissions Registration Process
To start the MHRA Submissions registration process you will need an MHRA five digit company number. If you have made submissions relating to Marketing Authorisations or Clinical Trial Authorisations before you will already have this (first 5 digits; PL number/CTA number/MHRA account number for e-cigarette producers). If not, you need to email: reference.data@mhra.gov.uk to register as a new company and be assigned a company number.
MHRA Additional Guidance
MHRA provides more guidance here:
https://www.gov.uk/guidance/registering-to-make-submissions-to-the-mhra-from-1-january-2021
This includes video demos and two User Reference Guides to help companies through the registration process and subsequent management of their organisation registration going forward.
If you have any questions about the MHRA Submission Portal, please contact us. S-cubed has an MHRA company number and is able to continue managing submissions to the UK as well as the EU on behalf of our clients. If you need help with submissions, please get in touch!
Subscribe to our updates and get them direct to inbox: https://www.s-cubed-global.com/news-and-articles#subscribe