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Process to change a registered OTC medicine
V1.2, June 2017
Step 11 - Evaluating and requesting information
This step is evaluating an application to change the ARTG entry for a registered OTC medicine.
Evaluating the application
Evaluating an application to change a registered OTC medicine involves us:
- assessing the data and information
- reviewing your responses to our requests for information
- documenting the findings
- aiming to complete the evaluation within target times.
Requests processed as notifications are not evaluated.
We may send you a request for information (RFI) seeking clarification, or to any address issues identified. The maximum number of requests we make are:
- one for C1 and C2 applications
- two for C3 and C4 applications.
We make these requests under section 31 of the Act and include a timeframe for you to respond. We apply standard response timeframes to requests for information.
Responding to requests for information
It is important that you respond to our RFIs within the given timeframes and provide complete and accurate information. Do not provide additional data unless we have specifically requested it - see Unsolicited information.
If we do not receive your response within the timeframe or you only send a partial response, we will proceed with the evaluation based on the information we have available.
If you do not provide all of the information requested and the outstanding issues are significant, the decision maker may decide not to approve the application (Step 13).
Due date for responding to requests for information
Do not wait until the response is due to request an extension of time.
We will not extend the due date unless you can demonstrate that the time allowed is not reasonable.
How to prepare your response
If the request for information relates to the content of a module of the submission dossier:
- Provide an electronic copy of the response in CTD format.
We do not evaluate unsolicited information or data, unless it is:
- New safety data that might negatively influence the benefit-risk assessment of the medicine. You are obligated to inform us about this as soon as it becomes available.
- Updated TGA manufacturing licences or clearances for the sites listed in the application.
Ensure the application dossier is complete when you submit your application.
Seeking advice from expert advisory committees
We may decide to seek advice from an expert advisory committee, such as the Advisory Committee on Non-prescription Medicines (ACNM), on specific issues relating to the application.
This is more likely to occur for higher level applications, particularly when the application is the first of that type. For most 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.
Applications submitted at the incorrect level
If during evaluation, we determine that your application passed screening at the incorrect application level because you did not select the correct change codes and your application cover letter did not contain adequate information relating to the application level and data requirements, we will:
- inform you that the application will be restricted to the application level that was accepted during screening
- only evaluate data required for the accepted application level
- advise you of the changes you need to make to meet the relevant criteria for the application level, detailed in determining the application level for an OTC medicine.
If you cannot make the changes, the decision maker may decide not to approve the application (Step 13).
In this case, you will need to reapply and include all of the required data for the correct application level if you wish to register the medicine.
An application submitted at level C2 passes screening and is accepted for evaluation.
During evaluation we note the medicine labels included a new indication, which was not identified in the application form or raised in the cover letter and therefore not detected during screening.
Applications to introduce a new indication do not meet the criteria for a C2 level application and require supporting safety and efficacy data and are made under a different section of the Therapeutic Goods Act 1989.
We inform the applicant that the change to the indications needs to be removed from the labels, consistent with the changes identified in the application form and the criteria for a C2 level application.
Timeframes for the evaluation
Our aim is to complete the evaluation within the target times for OTC medicine applications.
These target times:
- differ for each application level
- apply to the TGA processing time
- do not include the time you take to respond to a request for information.