Recipients Information [PRODUCT for INTENDED USE] An emergency has been declared by the Ministry of Health [INCLUDE A BRIEF DESCRIPTION (1-2 sentences) OF THE EMERGENCY]. The MCA has authorised the emergency use of [PRODUCT] for [IDENTIFY THE INTENDED USE (+ Dosing)]. This authorisation will terminate on [DATE 1 YEAR FROM THE DATE OF DECLARATION], or when the emergency has ceased to exist, whichever is earlier. The information in this condition of use is the minimum necessary to inform you of the significant known and potential risks and benefits of emergency use of [PRODUCT]. The significant known and potential risks and benefits of emergency use of [PRODUCT] are: [LIST]. The extent to which such risks and benefits are unknown is [EXPLAIN]. The available alternatives to [PRODUCT] are: [LIST]. The risks and benefits of [ALTERNATIVES] are: [LIST]. [If there is no alternative, provide an explanation of outcomes of exposure or of any special public health measures (e.g. quarantine or monitoring) that an individual who does not receive the EUA product may face.] [INCLUDE NAME, ADDRESS, AND TELEPHONE NUMBER FOR MANUFACTURER.] You have the option to accept or refuse administration of [PRODUCT]. The consequences of refusing administration of [PRODUCT] are [LIST]. Available alternatives to [PRODUCT] are: [LIST]. The risks and benefits of these alternatives are: [LIST]. Potential adverse events for [PRODUCT] include [LIST]. Should you experience an adverse event, [INCLUDE INSTRUCTIONS]. Any significant new findings observed during the course of emergency use of [PRODUCT] will be made available [STATE HOW FINDINGS WILL BE MADE AVAILABLE]. Page 1 of 1
