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OTC new medicines registration process
Step 10 - Evaluating and requesting information
During this step in the process, to register an OTC medicine, we will undertake the evaluation and may request additional information.
Evaluating the OTC medicine application
During evaluation of your OTC medicine application, we will:
- assess the data and information
- review your responses to our requests for information
- document our findings.
Our aim is to complete the evaluations 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.
We stop the clock when we send you a request for information and restart the clock once we receive your response addressing the issues.
Requesting additional information
We may request you to provide information to clarify or address issues that we identify. The maximum number of requests for information we usually make are:
- one for N1 and N2 applications
- two for N3, N4 and N5 applications.
We make these requests for information 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 requests for information within the given timeframes and provide complete and accurate information.
If you do not provide all of the information requested and the outstanding issues are significant, the decision maker may decide not to register the medicine in (Step 11) based on available information.
Preparing 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.
- Do not provide additional data unless we have specifically requested it (see Unsolicited information).
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.
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.
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 and that the mandatory requirements are met when you submit your application.
Expert advisory committee advice
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.
The OTC medicines advisory committee process 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 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 register the medicine in Step 11.
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 N3 passes screening and is accepted for evaluation.
During evaluation we note the medicine labels include an extension of target population, directions for use and a new claim, which were not raised in the cover letter and therefore not detected during screening.
Applications for medicines for use in an extended target population, with new claims and directions for use, do not meet the criteria for an N3 level application and require supporting safety and efficacy data.
We inform you (the applicant) that the target population, directions for use and claims will be restricted to those that meet the criteria for an N3 level application.