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ARGOM Appendix 3: Guidelines on presentation aspects of OTC applications
5. Consumer Medicine Information (CMI)
The Therapeutic Goods Regulations 1990 require that sponsors supply Consumer Medicine Information (CMI) with all 'Pharmacist Only Medicine' (Schedule 3) products.
The CMI must be:
- written in English
- clearly legible
- written in language that can easily be understood by consumers
- consistent with the approved or proposed PI.
The CMI must comply with the requirements specified in Schedule 13 of the Regulations, although the information does not have to be set out as listed there. CMIs must not include promotional material (refer to the ASMI Code of Practice for further information regarding promotional material). The CMI may be provided in the primary pack (e.g. as a leaflet in the carton) or 'in another manner' (e.g. in electronic form via pharmacy computers).
The sponsor is responsible for writing, updating, and distributing the CMI to the point of supply of a medicine to the patient. The information contained in the CMI should be easily read and understood by the Australian consumers. Sponsors are encouraged to utilise relevant guidance documents which provide advice on writing for consumers as well as refer to Core CMIs. Information on relevant guidance documents and the Core CMIs are available from the Australian Self Medication Industry (ASMI) website.
5.1 Requirements for the CMI following changes to scheduling classification
5.1.1 Schedule 3 Pharmacist only medicines
All applications to register new 'Pharmacist Only Medicine' (Schedule 3) products should be accompanied by a draft CMI document which will be evaluated as part of the application.
Submission of a draft CMI will also be required with variation applications arising when a product is rescheduled to 'Pharmacist Only Medicine' (Schedule 3) (e.g. down-scheduling from 'Prescription Only Medicine' (Schedule 4) or up-scheduling from 'Pharmacy Medicine' (Schedule 2) or unscheduled).
5.1.2 Down-scheduled from Schedule 4 Prescription only medicines to Schedule 3 Pharmacist only medicines
Products that have been down-scheduled from 'Prescription Only Medicine' (Schedule 4) status should already have a PI and CMI. Where no changes to the current CMI are proposed, the sponsor should provide a copy of the current CMI, together with an assurance that no changes have been made. Changes to the CMI may be needed if only some of the prescription indications are approved for the OTC product, and to ensure that the directions for use are consistent with those on the proposed product labelling. Other aspects of the CMI may also need to be updated.
5.2 Changes to the CMI
Where changes are made to the CMIs that are supplied as a package insert, a variation application should be submitted to the TGA requesting approval of the amended CMI50. Changes to CMIs that are not supplied as a package insert need not be approved by the TGA, provided all changes are consistent with the approved PI and product labelling. Where a change is required as a result of an amendment to the PI, the CMI should be updated without delay to ensure that it is consistent with the PI, as required by Schedule 13 of the Regulations.
Relevant changes to CMI should be highlighted (e.g. through the provision of 'track changes' labels or a table detailing all the proposed changes).
Changes to CMIs that are supplied as a package insert are treated in the same way as changes to product labelling.
- Refer to the application process for variation to the register (to be finalised)