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OTC medicines advisory committee process
We may decide to seek advice from an expert advisory committee, such as the Advisory Committee on Non-prescription Medicine (ACNM) 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, an application involving an indication that has not been approved by us for similar medicines may be referred to the ACNM.
For most OTC applications, we do not seek the advice of an expert advisory committee.
Seeking advice from the ACNM will typically extend the evaluation phase by three to six months. If you have a higher level application, that is likely to be referred to the ACNM, you should factor this into the target timeframes.
Setting the meeting date
If we seek advice from the ACNM, we will both:
- notify you at the earliest opportunity of the anticipated ACNM meeting date
- send you a copy of our evaluation report at least one month before the date of the meeting so that you can provide comments on the evaluation report for the ACNM to consider.
Providing comments for ACNM
You will have an opportunity to provide comments for the ACNM to consider.
When providing comments, make sure you:
- respond within two weeks of receiving the evaluation report
- limit your comments to three A4-size pages
- only address specific issues raised in the evaluation report as additional data will not be accepted
You can raise any minor administrative issues with the TGA outside of the ACNM meeting.
We will send you a copy of the ACNM draft minutes within 6 weeks of the meeting.
After considering the advice of the ACNM, 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 regarding the application
- give you the opportunity to respond to any issues raised by the ACNM and any other matters identified by us. In this case, you will receive a Request for information.
Whilst the advice provided by the ACNM is important, the decision maker is not obliged to follow the advice as it forms only part of the information upon which the regulatory decision is made.
- Statutory advisory committees
- OTC medicines registration process
- Process to change a registered OTC medicine
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||OTC Medicines Regulatory Guidance||November 2015|