How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Sign in to the MHRA Portal. There is a link for you to register online.
See thefor extra help.
You can register up to 7 people for free (including training for 2) and then pay for additional people to be added or trained.
As part of the registration process you will need 2 administrators to enrol and pass the online training before you can start using the portal. The training is free and we expect the administrators to train other portal users in the organisation.
Once registration and terms and conditions have been processed, the portal helpdesk team will arrange access to the online training material.
You need to provide names of 2 administrators you want registered on the online registration form on the portal’s front page.
Besides these 2 administrators, you can add up to 5 further named users. They will need to be trained by your administrators.
Additional users: fees
If you need more than 7 named users, you must contact MHRA to request a further bundle of 5 people to be added.
The cost is £1,000+VAT for the bundle with 5 people which needs to be renewed annually.
Any additional training at MHRA costs £250+VAT per person.
Use the portal for applications
You can use the portal to submit application forms electronically. Although you can submit paper application forms on CD in most cases, it is recommended to use the portal.
The forms on the portal include:
- application for a marketing authorisation (MA)
- change of ownership of an MA
- general product licensing submission (licence cancellations, information updates, periodic benefit risk evaluation reports (PBRERs) and various certifications)
- application for a traditional herbal registration (THR) licence for a traditional herbal medicinal product
- application for a homeopathic registration licence for a homeopathic medicine
- information submission for your MA
- active substance master file for your product
- application for a product licence parallel import (PLPI)
- application to renew your marketing authorisation, traditional herbal registration or other licence
- variation application for MAs
- certificate of manufacturing status application
- certificate of a pharmaceutical product application
- number allocation (PL XXX) as references for applications
Use the portal to access MHRA updates
If you are registering for the E2B messaging standard to send and receive information on adverse drug reactions to MHRA, you can receive this in the form of an anonymised single patient report (ASPR) via the portal in the meantime. However, your regulatory department will need to request this first by emailing email@example.com. You need to register for the portal before doing this.