Guidance

MHRA Portal: register to submit forms

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 the How to register for MHRA Portal and RamaXL (PDF, 700 KB, 11 pages) for 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.

Training

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.

Register users

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.

Application forms for the portal

  • 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
Published 18 December 2014
Last updated 8 October 2019 + show all updates
  1. Removed reference to submitting application forms by CD, as this facility is no longer available.

  2. Updated the registration guidance PDF

  3. Removed reference to using the portal to access MHRA updates.

  4. First published.