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UK MHRA: Guidance on Operational Information Sharing

Earlier today (02 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Operational Information Sharing" that provides detailed information for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.

Operational information is defined as administrative information about an application.

To ensure the smooth functioning of the medicine approval process, the Medicines and Healthcare products Regulatory Agency ("MHRA") has developed a process to share operational information with health system partners across the UK. This procedure applies to medicines being approved under the National and International Recognition routes.

In order to minimize delays in patient access to newly authorised treatments, information sharing with health system partners is intended to facilitate the most efficient access to medical products. As soon as consent has been obtained from the proposed MAH, information will be shared with health system partners who have made appropriate commitments on how the data will be used and stored.

Some of the Health Partners who 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

For further information on How to provide consent, Information management, Consent and withdrawal click this LINK.


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