Government Notice 99  in the Malta Government Gazette number 17,716 titled "Standards to Ensure Quality and Safety of Human Blood and Blood Components" and DH Circular No 48/2005 titled "Serious Adverse Events & Serious Adverse Reactions to Blood and Blood Components" lay out the obligations of blood establishments and hospital blood banks with respect to the standards that shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion

The Medicines Authority is responsible for the collection of both serious adverse events (SAEs) and serious adverse reactions (SARs) to blood and blood components. Blood establishments and hospital blood banks are reminded to notify the Medicines Authority of SAEs using the Blood SAE Reporting Form. Hospital blood banks, and all other facilites to which blood or blood components may be delivered e.g. hospitals, clinics, manufacturers and bio-medical research institutions, are reminded to notify the Medicines Authority of SARs using the Blood SAR Reporting Form, and the Blood SARs Imputability Level Guidance Sheet  for the determination of the imputability level of the SAR reported.'