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We may seek advice from an expert advisory committee, such as the Advisory Committee on Medicines (ACM) during the evaluation of an application to register or change an over-the-counter (OTC) medicine.
This is more likely to occur for higher level applications, particularly when the application is the first of that type.
For example, we may refer an application to the ACM if it involves an indication we haven't approved for similar medicines.
We don't seek the advice of an expert advisory committee for most OTC applications.
Evaluation timeframe
Seeking advice from the ACM will typically extend the evaluation phase by 3 to 6 months. If you have a higher level application that's likely to be referred to the ACM, you should factor this into the target timeframes.
Setting the meeting date
If we seek advice from the ACM, we will both:
- notify you at the earliest opportunity of the anticipated ACM meeting date
- send you a copy of our evaluation report at least one month before the date of the meeting so you can provide comments for the ACNM to consider.
Providing comments for the ACM
You will have an opportunity to provide comments for the ACM to consider.
When providing comments, make sure you:
- respond within 2 weeks of receiving the evaluation report
- limit your comments to 3 A4-size pages
- only address specific issues raised in the evaluation report as extra data won't be accepted.
You can raise any minor administrative issues with us outside of the ACM meeting.
ACM outcomes
We will send you a copy of the ACM draft minutes within 6 weeks of the meeting.
After considering the advice of the ACM, the decision maker (referred to in the therapeutic goods legislation as the delegate for the Secretary of the Department of Health) may either:
- make a decision about the application
- give you the opportunity to respond to any issues raised by the ACM and any other matters identified by us. In this case, you will receive a Request for information.
Whilst the advice provided by the ACM is important, the decision maker is not obliged to follow the advice as it forms only part of the information on which the regulatory decision is made.