The advertising rules for therapeutic goods in Australia are very strict and quite different from other countries. What you can say and not say is very closely tied to the approved or permitted indications eventually included on your product authorisation. Hence the consideration of how you intend to advertise your product is something that should be done at the same time as you are planning your product submission and labels or leaflet presentation. Often the advertising is left until the end after approval – but at that time it is too late and usually a costly and timely exercise to make any changes if your approval does not cover everything you want to say about your product. Also, you need to be aware that there are certain phrases/wording that may require additional approval outside of the product application process, if you wish to include them in your advertising to the public. This includes printed and electronic media, especially in this day and age of social media influencers.
Regulatory Concepts can work with your marketing team to review your proposed campaign and make sure that the wording and presentation you intend to use will be acceptable and if necessary we can assist with any additional approvals that may be required.
Specifically with reference to listed medicines, we can make sure that your advertising is covered by your evidence summary
