Guidance

Operational Information Sharing Guidance

Updated 2 January 2024

1. Introduction

The Medicines and Healthcare products Regulatory Agency (“MHRA”), as an Executive Agency of the Department of Health and Social Care (“DHSC”), has developed a process to share operational information with health system partners (see in Section 5) across the UK. This applies to medicines’ applications submitted via National and International Recognition regulatory routes.

Marketing Authorisation (“MA”) Applicants submitting relevant regulatory applications will be asked to provide consent to share operational information (detailed below in Section 4) to support timely patient access to medicines. Consent to share operational information does not affect any other processes undertaken by the MHRA as part of its regular activities or duties.

Where consent from the proposed Marketing Authorisation Holder (“MAH”) has been obtained, operational information for applications for an initial MA or a variation for extension of indication will be shared with health system partners to enable them to plan and execute their operational processes more efficiently.

2. Purpose

The aim of information sharing with health system partners is to enable the most efficient access of medical products to patients, minimising delays in patient access to newly authorised treatments.

In particular, the sharing of this information will facilitate the planning and scheduling of health technology evaluation by Health Technology Assessment (“HTA”) bodies across the United Kingdom to support the publication of timely guidance; and will enable National Health Service (“NHS”) services across the four UK nations to schedule in any preparatory activities, necessary to proactively manage access arrangements related to the commissioning of new medicines and services for patients.

Where consent from the proposed MAH has been obtained, information will be shared with health system partners who have made appropriate commitments as to the use and storage of the information. The commitments include that the information shared will not be used for any other purpose, and will not be used to inform evaluation or procurement / reimbursement decisions made by health system partners.

3. How to provide consent

MA Applicants can now consent to operational information about individual applications being shared with health system partners across the UK as part of the online MA application process on MHRA’s Human Medicines Portal. Further detail can be found in Section 6 below.

4. Information shared

Operational information is defined as administrative information about an application. MHRA will share the following operational information:

• Application details: Applicant, product name (where available), active substance / INN, route of administration and the proposed indication.
• Application processes: submission date, regulatory route, reference regulator for International Recognition route, and whether the application is for a new MA or a variation for extension of indication.
• Estimated timelines: the estimated potential MA approval date, and the actual MA grant date, should the medicine be authorised.

MHRA will provide this information for medicines going through the National route, including Orbis, Access, GB (non-reliance) products, and through the International Recognition route. It will provide this information for a new active substance MA or a variation application to extend an indication.

Shared information may be updated over time if it remains within the scope of the above three categories. Where changes are made to the operational information shared, consent to share this additional information will be sought from the proposed MAH.

5. Health system partners

The following health system partners, from across the United Kingdom, are expected to commit to the underpinning Operational Information Sharing arrangement to access the operational information shared:

• The National Institute for Health and Care Excellence (NICE)
• National Health Service England (NHSE)
• All Wales Therapeutics and Toxicology Centre (AWTTC)
• NHS Wales Shared Services Partnership (NWSSP) hosted by Velindre NHS Trust
• Scottish Medicines Consortium (SMC) as part of Healthcare Improvement Scotland (HIS)
• NHS National Services Scotland (NHS NSS)
• Scottish Government
• Welsh Government

Operational information will only be shared with health system partners following their commitment to the underpinning Operational Information Sharing arrangement.

6. Consent and withdrawal

MA Applicants can now consent to operational information about individual applications being shared with health system partners across the UK as part of the online MA application process on MHRA’s Human Medicines Portal.

Consent to share operational information for the purposes set out above (see Section 2) must be provided by, or on behalf of, an authorised signatory who is able to provide the assurances required on behalf of the proposed MAH.

Those who do not consent to share operational information with health system partners may continue to submit applications for licenses and current applications will be unaffected. However, providing partners with an earlier indication of the likely MA timeline will help to mitigate potential delays in patient access.

MA Applicants who do not consent to share operational information at the point of application submittal may provide consent at a later date by contacting partnerships@mhra.gov.uk However, please note that it may not be possible to retrospectively provide consent for all applications undergoing MHRA assessment at this time.

MA Applicants can withdraw consent to share operational information related to a specific application at any time by contacting partnerships@mhra.gov.uk

Once notification of consent withdrawal has been received for an application, MHRA will stop sharing the operational information with immediate effect. Any information shared prior to notification of consent withdrawal will remain subject to confidentiality arrangements with health system partners who have committed to the underpinning Operational Information Sharing arrangement.

7. Information management

MHRA will share operational information with health system partners on the basis that it is to be treated by them as confidential. The information will be provided to health system partners on the basis that it will only be shared with the necessary staff within our health system partner’s organisations for the stated purpose, including by transfer of the information to the partner’s information systems. All information will be retained by MHRA in accordance with MHRA’s information management processes and policies.

Operational information will only be shared with health system partners who have committed to the underpinning Operational Information Sharing arrangement. The arrangement commits partners to handle the information in accordance with their information management processes and not to share the information with third parties, unless they are required to do so by law.

Further information on how MHRA handles personal data, including rights of individuals in relation to that data, can be found in its privacy notice here.

If you have any questions about operational information sharing, please contact partnerships@mhra.gov.uk