Guidance

How to provide consent for operational information sharing

Updated 2 January 2024

Marketing Authorisation (MA) Applicants submitting relevant regulatory Marketing Authorisation Applications (MAAs) will be asked to provide consent to share operational information with cross-UK health system partners during the MAA process on the MHRA’s Human Medicines Portal (HM Portal). 

This guide shows how consent will be requested via the HM Portal during the MAA submission process, and how MA applicants can provide consent to share operational information during the MAA process. 

Consent to share operational information must be provided by, or on behalf of, an authorised signatory who is able to provide the assurances required on behalf of the proposed Marketing Authorisation Holder (MAH). 

For any further queries please contact partnerships@mhra.gov.uk.

Please follow the relevant guidance that explains how to submit MAA for medicines via the HM Portal (available at Webinars: information on how to make submissions to the MHRA).

After selecting ‘Submit application’ in the appropriate page, the next screen of the application submission process captures the regulatory activity. Please proceed with your application filling in the ‘Regulatory Area’ section in accordance with the above guidance and as required for your application.

For your information, consent to share operational information will only be requested for ‘Human Medicines’ applications when one of the following options are selected from the drop-down list in ‘Regulatory Activity’ along with ‘Original Submission’ from the ‘Regulatory Sub Activity’ drop-down list during the MAA process.

• ‘Initial Marketing Authorisation NAS – National’
• ‘Initial Marketing Authorisation NAS – IR Route A’
• ‘Initial Marketing Authorisation NAS – IR Route B’
• ‘Variation Type II – National (New Indication)’
• ‘Variation Type II – International Recognition (New Indication)’

In the next steps of the MAA process, proceed with your application filling in the ‘Procedure’, ‘Emails’, ‘Products’ and ‘Supporting Documents’ as required per your application.

Following confirmation of upload of documents as required per your application, for the relevant MAAs detailed in point 2, the proposed MAH will be asked to provide consent to share operational information to support timely patient access to medicines as shown in the screen below.

Click ‘MHRA’s Operational Information Sharing Guidance’ to go to the gov.uk page (https://www.gov.uk/government/publications/operational-information-sharing) containing all the information about operational information sharing. Please read carefully the gov.uk page on Operational Information Sharing, and the Operational Information Sharing Guidance document on the linked page.

Please ensure again that you are the appropriate person to give consent for operational information sharing. At this stage, if you are the / on behalf of the authorised signatory who is able to provide the assurances required on behalf of the proposed MAA select ‘Yes’, if you consent to operational information being shared with our health system partners as indicated in MHRA’s Operational Information Sharing Guidance (https://www.gov.uk/government/publications/operational-information-sharing).

Then click ‘Submit’ and continue your MAA as required per your application.

Once the application is submitted, and if you have selected ‘Yes’ to share operational information, consent will have been given to share operational information with our health system partners.