Industry Guidelines and Regulations
The CMI is written in line with Usability Guidelines for Consumer Medicine Information "Writing about medicines for people".
This guideline ensures the information is formatted to a specific style and layout and contains accurate, unbiased information about your medicine that is easily understood by everyone.
CMI content is regulated under the Therapeutic Goods Regulations 1990, sub regulation 9A:
Sponsors must supply the goods with written information that meets the requirements for a patient information document set out in Schedules 12 and 13
Sub-regulation (1) or (1A):
Information must be provided -
In the primary pack
Or
In another manner that will enable the information to be given to a person to who the goods are administered or otherwise dispensed