A full review of schedule 1 Options for identification of Many industry stakeholders declarable excipients is declarable substances on raised issues with the beyond the scope of this labels of prescription and inclusion of a leaflet inserted labelling review. related medicines into the primary pack to However, to align with Food disclose schedule 1 declarable Standards Australia New excipients, citing unacceptable Zealand, a gluten declaration costs for sponsors when the has been prescribed where information is already gluten is present in a included in the consumer concentration of 20 parts per medicine information (CMI). million or more. A number of issues have been Some speciality health groups taken into account including also provided feedback on difficulties in including the specific schedule 1 excipients CMI in the pack; concerns (gluten, lactose), for example, about the ability to fit all the inconsistency between required information on schedule 1 and Australian medicine labels; the need for Food Standards Code. consumers to have consistent access to important safety information; the levels of risk associated with different excipients and dosage forms; the merits of determining threshold levels for excipient concentrations; and the possibility of greater harm resulting from medicines not being taken because of a perceived risk from exposure to certain excipients. Considering declarable excipients in schedule 1 may pose considerable safety risks to consumers, the prescription medicines Order has been amended to allow a choice of declaring the schedule 1 excipients through: declaration [of the specific excipients] on the label; or identified by a statement that directs consumers to the CMI. The point that identifies the declarable excipients is a ‘flag’ that alerts consumers and initiates a conversation with healthcare practitioners on appropriate medication. It does not necessarily preclude use of the medicine.
Options for identification of declarable substances on labels of prescription and related medicines Many industry stakeholders raised issues with the inclusion of a leaflet inserted into the primary pack to disclose schedule 1 declarable excipients, citing unacceptable costs for sponsors when the information is already included in the consumer medicine information (CMI). Some speciality health groups also provided feedback on specific schedule 1 excipients (gluten, lactose), for example, the inconsistency between schedule 1 and Australian Food Standards Code. A full review of schedule 1 declarable excipients is beyond the scope of this labelling review. However, to align with Food Standards Australia New Zealand, a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more. A number of issues have been taken into account including difficulties in including the CMI in the pack; concerns about the ability to fit all required information on medicine labels; the need for consumers to have consistent access to important safety information; the levels of risk associated with different excipients and dosage forms; the merits of determining threshold levels for excipient concentrations; and the possibility of greater harm resulting from medicines not being taken because of a perceived risk from exposure to certain excipients. Considering declarable excipients in schedule 1 may pose considerable safety risks to consumers, the prescription medicines Order has been amended to allow a choice of declaring the schedule 1 excipients through: declaration [of the specific excipients] on the label; or identified by a statement that directs consumers to the CMI. The point that identifies the declarable excipients is a ‘flag’ that alerts consumers and initiates a conversation with healthcare practitioners on appropriate medication. It does not necessarily preclude use of the medicine.
General-requirements-for-labels-for-medicines-RIS.docx