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HTA-licensed establishments in the post mortem sector are required to report incidents (HTARIs), and those in the human application and organ donation and transplantation sectors are required to report serious adverse events or reactions (SAEARs), as part of their licensing with us.
Issued 2 November 2016
• Designated Individuals (DIs) in the Human Application (HA) sector • Licence contacts in the Organ Donation and Transplantation (ODT) sector
7 December 2015 update: The French Competent Authority issued an update to itsalert. The update noted that additional precautions taken in France following detection of this case of West Nile Virus in October 2015 were no longer in force.
Issued 27 November 2015
The Department of Health and Social Care has published guidance for industry and organisations involved in health and care about plans for a no-deal Brexit.
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector