OPERATIONAL INFORMATION SHARING OVERVIEW
The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on Operational Information Sharing with health system partners.
The MHRA has developed a process to share operational information regarding medicines’ applications submitted via National and International Recognition regulatory routes. This initiative aims to support timely patient access to medicines by enabling health system partners to plan and execute their operational processes more efficiently.
The full guidance document is available on GOV.UK: HERE.
TIMELINE & PROCESS FOR MANUFACTURERS
The publication of this guidance clarifies the process for Marketing Authorisation (MA) Applicants.
Consent Process
- Submission Stage: MA Applicants can now consent to operational information being shared as part of the online MA application process on the MHRA’s Human Medicines Portal.
- Late Consent: Applicants who do not consent at submission may provide consent later by contacting the MHRA, though retrospective consent for applications already under assessment may not be possible.
- Withdrawal: Applicants can withdraw consent at any time. Once notification is received, the MHRA will stop sharing information with immediate effect.
Key Dates
- 2 January 2026: The Department of Health Northern Ireland (DoH NI) will only receive information for products submitted from this date onwards.
INFORMATION SHARED
Where consent is obtained, the MHRA will share specific “operational information,” defined as administrative data about an application. This does not affect other MHRA regulatory duties.
The specific data points shared include:
- Application Details: Applicant name, product name (if available), active substance/INN, route of administration, and proposed indication.
- Application Processes: Submission date, regulatory route (e.g., National, Orbis, Access, International Recognition), and reference regulator details.
- Estimated Timelines: The estimated MHRA decision date and the actual MHRA decision.
IMPACTED HEALTH SYSTEM PARTNERS
Operational information will only be shared with partners who have committed to the underpinning Operational Information Sharing arrangement. These partners have committed to keeping the information confidential and not using it for procurement decisions.
The following partners are included in this arrangement:
- 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
- Department of Health Northern Ireland (DoH NI)
RESOURCES
To assist applicants with this new process, the following resources are available:
- Full Guidance: Operational Information Sharing Guidance – GOV.UK
- Privacy Notice: MHRA Privacy Notice
Questions about operational information sharing? Contact the MHRA partnerships team at: [email protected].