Blood: authorisations and safety reporting

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) governs the safety and quality of human blood and its components under the Blood Safety and Quality Regulations (BSQR). The regulatory framework applies to Blood Establishments (BEs), Hospital Blood Banks (HBBs), and healthcare facilities. BEs are required to hold a Blood Establishment Authorisation (BEA) and must undergo mandatory inspections at least once every two years. In contrast, HBBs must submit an annual Blood Compliance Report (BCR)—with the next deadline set for April 30, 2026—which the MHRA uses to determine inspection frequency based on organizational risk. Key compliance issues focus on the reporting of serious adverse reactions and events via the SABRE system, maintaining rigorous traceability, and ensuring adequate documentation for secondary processing and distribution. Required actions for these organizations include the payment of annual fees, the submission of accurate pre-compliance reports, and the formalization of service level agreements between facilities and HBBs. Failure to maintain these standards or to report significant operational changes through the variation process can lead to the withdrawal of authorization. This oversight ensures that all activities related to the collection, testing, and supply of blood meet national safety requirements.