Blood Bank Laboratory application and New Annex

Blood Bank Laboratory application forms (AF-1-D) should be completed in conjunction with Annex AF-1-D-BB "Annex to AF-1-D for Blood Banks for compliance with Article 14 & 15 of EU Directive 2002/98/EC".

This annex requests documentation specifically related to traceability and haemovigilance aspects. Please see AML-BB “Minimum requirements for Blood Bank Compliance with Article 14(Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC.”