MHRA Portal: register to submit forms

Register users

You can register up to 7 people for free to use the MHRA Portal and also opt to register and pay an annual subscription to use RamaXL.

You need to provide the names of 2 administrators when completing the registration form.

Besides these 2 administrators, you can add up to 5 further named users. They will need to be guided by your administrators.

Fees

MHRA Portal

There is no cost for the 2 administrators and 5 other named users.

If you need more than 7 named users, you must contact the MHRA to request a further bundle of 5 people.

The cost for the bundle with 5 people is £1,000 (excluding VAT), which needs to be renewed annually.

RamaXL

RamaXL is a subscription service with an initial one-off registration cost of £7,750 (excluding VAT).

The basic subscription provides access to 5 users (1 bundle) at an annual cost of £15,500 (excluding VAT). You can buy additional bundles at an annual cost of £6,700 (excluding VAT). Each bundle is for 5 users. 

Application forms for the portal

You can use the MHRA Portal for:

• 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

Completing the registration form

At the top of the form, indicate whether you are applying to use the MHRA Portal and/or RamaXL by ticking the relevant option(s) .

Section 1 

In section 1.1  the company director is the person legally responsible for the company, and is registered at Companies House or equivalent. You must enter their residential address. We will not accept any other address. Please specify if you cannot provide the residential address. 

Section 3 

Select Yes or No. 

If you select Yes, you must enter the parent company name and add any associated company names. 

Section 4 

When you click the Generate reference number button you will receive your reference number by email (if the button does not work, complete the form and send it to portal.manager@mhra.gov.uk). 

Copy the reference number from the email (make sure you do not copy the space after the last character) and paste it in the reference number field in the form. 

Click the Terms and conditions link to read the terms and conditions, then tick the box to acknowledge that you have read them. 

The company director must sign both the MHRA Portal and RamaXL terms and conditions need to be signed if both are required.

If the company director is the signatory for all the associated companies, list the companies and the company number on the same form. Please type the company name in full (for example, Pharmalabs – PL 99000). If the companies have different directors, they will have to sign individual terms and conditions for each company.

Click ‘Submit to the MHRA’ button to send the form.  

MHRA Portal registration form

Use the MHRA Portal registration form to register your organisation to use the MHRA Portal or RamaXL.

What happens next

The MHRA Portal team will send you an email acknowledging receipt of your application. Checks will be conducted to verify the information provided.

After verifying the information provided, we will organise with IT for your pending applications to be migrated to your workspace for future updates.

You will only be able to log onto the MHRA Portal once the Portal team has added your email address as your username and you have received an email from IntraLinks with a temporary password.

Contact

For further information, contact us by:

• email portal.manager@mhra.gov.uk
• phone 0203 080 7100