Guidance

Operational Information Sharing

Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 1 January 2024
• Last updated: 2 January 2024 — See all updates

Documents

Operational Information Sharing Guidance

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How to provide consent for operational information sharing

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How to provide consent for operational information sharing (PDF)

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Details

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 for new active substance MAAs or variation for extension of indication applications with health system partners across the UK to support timely patient access to medicines. This applies to applications submitted via National and International Recognition regulatory routes.

The Operational Information Sharing Guidance explains the purpose of operational information sharing with health system partners, the nature of the information shared, and the consent, withdrawal of consent, and information management processes.

The instructions for MA applicants illustrate how consent will be requested during the Marketing Authorisation Application (MAA) submission process for relevant MA applications via the Human Medicines Portal, and how MA applicants can give consent for operational information to be shared with our health system partners.

Published 1 January 2024
Last updated 2 January 2024 + show all updates

1. 2 January 2024

   Amended to add attachment on how to provide consent for operational information sharing.

2. 1 January 2024

   First published.