UK MHRA Guidance: Operational Information Sharing

The Operational Information Sharing Guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA) provides structured instructions for Marketing Authorisation (MA) applicants on how to consent to the sharing of operational information during the MA application process. This guidance supports improved planning across the UK health system to enable faster and more efficient patient access to newly authorised medicines. This applies to applications submitted through both National and International Recognition regulatory routes.

The main objective of sharing operational information is to support timely access of medicines for patients by helping health system partners prepare operationally — from planning service delivery to commissioning treatments.

This approach is designed to:

• Enable efficient scheduling of Health Technology Assessment (HTA) activities across the UK.

• Allow NHS bodies in England, Scotland, Wales, and Northern Ireland to plan for commissioning and service activities related to new medicines.

• Align operational work of partners without influencing HTA evaluations or reimbursement decisions.

The guidance clarifies that information will only be shared with partners who commit to strict use and storage conditions, ensuring the data is used solely for its intended operational purpose.

How to Provide Consent

MA applicants are invited to provide consent during the online MA application process in the MHRA’s Human Medicines Portal. This has been incorporated into the submission workflow to make consent a clear and straightforward choice for applicants.

Separate detailed instructions on how to provide consent through the portal are available in the associated guide: How to provide consent for operational information sharing.

Consent must be provided by an authorised signatory who can confirm the assurances on behalf of the proposed MAH.

Information Shared

“Operational information” refers to administrative data about a particular MA application. MHRA will share the following categories:

1. Application details:

   • Applicant name

   • Product name (where available)

   • Active substance / INN

   • Route of administration

   • Proposed indication

2. Application process information:

   • Submission date

   • Regulatory route

   • Reference regulator for international routes

   • Whether the application is an initial MA or a variation for an extension of indication

3. Estimated timelines:

   • Estimated MA approval date

   • Actual grant date once authorised

Information may be updated in accordance with its relevance. Any additional data beyond the agreed scope will require renewed consent from the MAH.

Health System Partners

Operational information will be shared only with partners that have agreed to the underpinning Operational Information Sharing arrangement. These partners include:

• 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)

• Scottish Medicines Consortium (SMC)

• NHS National Services Scotland (NHS NSS)

• Scottish Government

• Welsh Government

Since the 2 January 2026 update, the Department of Health Northern Ireland is now also included as a health system partner. These partners must commit to using the information only for operational planning and under agreed confidentiality protocols.

Consent and Withdrawal

Consent must be provided by an authorised signatory on behalf of the proposed MAH at the time of application. If consent is not granted at submission, applicants may still apply normally — but partners will not receive the operational information.

Applicants can later provide consent by contacting the MHRA although retrospective consent may not be possible for applications already under review.

Consent can also be withdrawn at any time by contacting the MHRA. Once withdrawn, the MHRA will stop further sharing immediately. However, any data already shared will remain under confidentiality terms agreed with health system partners.

All operational information shared with partners must be treated as confidential. Partners commit to using the data only for the purposes specified and to limit access to necessary personnel within their organisations.

For more details refer the guidance by clicking the below link:

Operational Information Sharing GuidanceOperational Information Sharing Guidance, updated 2 January 2026.