Medicines Healthcare Products Regulatory Agency
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.