Brief descriptions of the information presented in the Listed medicine compliance reports database are listed below.
Sponsor: The sponsor in this field refers to the sponsor of the listed medicine when it was reviewed by the TGA. The current sponsor for the medicine may be different if the sponsorship has changed since the review. The current sponsor of a medicine is displayed in the Australian Register of Therapeutic Goods (ARTG) .
ARTG: The ARTG ID is the unique identification code of a product included in the ARTG. The ARTG ID for listed medicines starts with 'AUST L' and is followed by a sequence of numbers. The ARTG ID is displayed on a medicine/s main label.
Date of review outcome: This field shows when the compliance review was closed by the TGA. Reviews are closed after we consider a sponsor's submissions, and the actions they took to rectify any identified issues.
Date cancellation takes effect (if applicable): This field shows the date when the medicine was no longer listed on the ARTG, if a listed medicine is cancelled from the ARTG by the TGA following a compliance review. A medicine cancelled from the ARTG cannot be supplied or marketed by the sponsor.
Date of publication: This field shows when the information about the compliance review was published on the database.
Outcome: The outcome following a compliance review indicates whether the medicine is still permitted to be supplied following the compliance review, depending on whether it remains on the ARTG or not. This field may include information about recalls, or corrective actions taken to address identified issues so that the medicine can continue to be supplied.
If the review outcome states that a medicine is 'no longer permitted to be supplied' this might not mean there were issues with the medicine, or that it is unsafe to continue using. A sponsor may voluntarily choose to stop supplying and marketing their medicine to consumers and cancel it from the ARTG. When this occurs, the outcome of the review will reflect that the medicine is no longer permitted for supply.
Is it safe to continue using this medicine?: This field will indicate either 'yes' or 'no', followed by specific directions for consumers as required.
The information in this field is based only on the information reviewed, and assessment performed by the TGA at the time of review.
The TGA might not assess the safety of a medicine during a compliance review. This may occur for various reasons, for example if the safety of the product was not a focus of the review, or if the sponsor chooses to stop supplying a product during the review. Where safety is not assessed, we assume it is safe to continue using the reviewed medicine, based on the sponsor's certification. Listed medicines must meet certain low-risk criteria, and sponsors must certify their medicine is safe for use before supply.
What action should consumers take?: This field outlines any recommended actions for consumers if they have taken, are taking, or intend to take the medicine.
Review scope: A listed medicine may be selected randomly or be targeted for a review.
Information reviewed: Information reviewed outlines the information evaluated by the TGA during the compliance review to determine whether the medicine met the relevant legal requirements. The type of information reviewed can include: the ARTG record of the medicine; labels; advertising; manufacturing documents; scientific or traditional evidence supporting what the medicine claims to do; laboratory testing results.
Issues related to safety: A summary of any issues identified during the compliance review that:
- have the potential or are likely to affect consumer safety
- are breaches of legal requirements that are in place to ensure the low-risk status of listed medicines, even if they are unlikely to pose a risk to consumer health and safety
Issues related to efficacy: A summary of any issues identified during the compliance review that have the potential or are likely to affect product efficacy (i.e. that the medicine does what it says it will do).
Actions taken during the review: A summary of the actions taken by the TGA and the sponsor during the compliance review, to address any issues identified by the TGA.
Grounds for cancellation (if applicable): This field explains why the medicine was cancelled from the ARTG, if the TGA cancelled the medicine during the review.
Additional information (if applicable): Any other relevant information about the medicine.
For more information visit the Listed medicine compliance reviews information page.