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This guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
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This guidance is intended to assist applicants to register a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
The following webpages:
If you have already determined your medicine (Goods represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the human body) is an OTC that requires registration on the ARTG and you have a client ID number and password to access TGA Business services go to Step 2.
To verify you have an OTC medicine that requires registration on the ARTG, go to the guidance:
Applications are created and lodged through Business services.
You will need both of the following to make an application:
If you do not have a Client ID number or access to our business services
Before you prepare your application to register an OTC medicine, you need to check if the medicine contains a new ingredient or has ingredients that require assessment.
Check whether the ingredients in the medicine are included in our relevant Tables under Public TGA Information on the business services homepage:
Submit the completed Notification of a Proprietary Ingredient form to obtain a proprietary ingredient ID number.
You will need the proprietary ingredient ID number to complete your application to register the medicine (Step 7).
There are two options to apply for approval of a new substance excipient (Any component of a finished dosage form other than an active ingredient) or active ingredient (The therapeutically active component in a medicine's final formulation that is responsible for its physiological action). You can either:
1. Apply as part of the OTC medicine application. If you choose this option, make sure to:
or
2. Apply before submitting the OTC medicine application. This option is usually only used for new excipients or active ingredients in sunscreens. If you choose this option, make sure to:
You will also need to propose a name for the new substance.
To do this:
Ingredients included in the Ingredient Table may not have been approved for your proposed use or at the proposed concentration.
The Ingredient Table includes limited information on the restrictions for use (for example, for topical use only).
The absence of restrictions in the Ingredient Table does not mean that the ingredient has been approved for your proposed use or at the proposed concentration.
If the proposed use or concentration is not typical for your ingredient or you are not sure whether your ingredient has been assessed for your proposed use or at the proposed concentration you can contact us.
If your ingredient requires assessment of safety and efficacy data make sure to:
Applications to register an OTC medicine are categorised into five levels, based on risk and have different fees and target evaluation times.
It is important that you determine the correct application level.
If your application does not include the required data, in accordance with the application level, it will not be accepted for evaluation under section 23(2)(b) of the Therapeutic Goods Act 1989.
When planning your OTC medicine application you will need to identify and understand the relevant mandatory requirements and guidelines.
Check all of the relevant guidelines for any specific requirements or advice that apply to your application:
The mandatory requirements explain what you need to do for your application to be effective, pass screening and be accepted for evaluation:
If you have read the applicable guidance and need our assistance, you can contact us. We will usually respond in writing as meetings are not needed for most OTC medicine applications.
You will need valid evidence that the manufacturers of your OTC registrable medicines have been certified to perform each step in the manufacture of the goods.
If you do not have valid evidence of GMP for each manufacturer, your application will not validate when you submit your application (Step 7).
We accept:
In both cases the evidence is valid only for the steps of manufacture and dosage forms nominated on the licence or clearance.
We cannot finalise your application without current and valid GMP (issued by the TGA) clearance for each overseas manufacturer. You need to ensure that the GMP clearance will not expire during the evaluation timeframe.
Check that the GMP clearance will not expire within the following minimum timeframe from when you submit your application in Step 7:
If the GMP clearance is due to expire within the minimum timeframe (see previous section) or is likely to expire before the application is finalised:
Consider applying to renew the GMP clearance for applications with a target evaluation time that exceeds 6 months rather than seeking extension of the GMP clearance. Extension to the expiry may not cover the full period, to completion, of the application.
If you have requested an extension, or applied to renew the clearance, state this in the cover letter of your OTC medicine application.
You will need to prepare your OTC medicine dossier of administrative and technical documentation to submit for evaluation.
You must submit an electronic application dossier.
To compile your dossier, follow the General dossier requirements.
Compile your electronic dossier according to the Common Technical Documentation (CTD).
To identify the CTD Modules you need for your application check:
Ensure your application dossier contains all of the administrative and technical data required for the application level.
It is important that you check to ensure your dossier:
We will check whether the application meets the requirements for an effective application during screening (Step 9). If your application does not meet the requirements to be effective, we will not accept it for evaluation.
In this step, you will be completing the OTC medicine application form and submitting your application.
To complete and submit your application, follow these steps and save your information as you progress through each page.
You will be automatically issued a submission number, which uniquely identifies the application.
Use this submission number in all future communications about the application.
You can monitor the workflow status of your applications through Business Services.
The application start date is the date that the fees are processed (see Step 8). When your fees have been processed the workflow status will change from 'Submitted' to 'Under Review', which means that the application is in screening (Step 9).
You can withdraw an application at any time up until the decision is made.
To withdraw an application, inform us in writing of the intention to withdraw the application.
If the application is withdrawn due to safety issues, we may ask you to provide any adverse safety data.
Note
When an application is withdrawn, we may retain the application and any material submitted in connection with the application.
We will refund the evaluation fee if the application is withdrawn before it enters the evaluation step in the process.
We do not refund the application fee.
When you apply to register an OTC medicine, we will invoice you for both the application fee and the evaluation fee that corresponds with the application level.
For details of the current fees, go to Schedule of fees and charges
You will automatically receive an invoice when you submit the application.
It is important to pay the application and evaluation fees when you receive the invoice as we do not start screening the application until the fees are processed.
We will assess the fees during screening (see Step 9) and, if necessary, we will issue:
If you submit an application and you submit additional applications at the same time, you can apply concurrent (reduced) fees to the eligible additional applications which have:
If you are eligible for concurrent fees, select this option and enter the relevant details when you complete your application (Step 7).
The concurrent fees are listed in the Schedule of fees and charges.
For information on fees and the available payment methods see:
If you are paying the application fees by cheque, do:
TGA Finance
PO Box 100
WODEN ACT 2606
Australia
Do not:
If we invoice you for additional evaluation fees these need to be paid in full within 2 months of the date of the invoice or the following will occur:
We will screen your OTC medicine application to verify that it has been submitted at the correct application level and it meets the requirements to be effective.
Your application is effective if it meets the requirements under section 23(2) of the Therapeutic Goods Act 1989. This means:
We rely on information in your application cover letter to confirm the application level and corresponding data requirements.
If your application cover letter does not contain information critical to verify the application level, we may not detect an application submitted at the incorrect level until evaluation in Step 10. This can have implications for you as explained in Step 10.
You will have an opportunity to make minor corrections, detected during the screening process, if the issue can be rectified promptly. For example, if we cannot locate an attachment that is mentioned in the cover letter, we will give you an opportunity to provide the attachment.
If your application is effective, we will:
If your application is not effective:
If you reapply to register the medicine on the ARTG, ensure your application meets the requirements for an effective application.
You cannot lawfully import, supply or export the medicine until you have an ARTG registration.
During this step in the process, to register an OTC medicine, we will undertake the evaluation and may request additional information.
During evaluation of your OTC medicine application, we will:
Our aim is to complete the evaluations within the target times for OTC medicine applications.
These target times:
We stop the clock when we send you a request for information and restart the clock once we receive your response addressing the issues.
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:
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.
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.
If the request for information relates to the content of a module of the submission dossier:
Do:
Do not:
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:
Ensure the application dossier is complete and that the mandatory requirements are met when you submit your application.
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.
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:
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.
Example
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.
Before making a decision on whether to register an OTC medicine, you may need to verify the details of the application, including any changes that may have been made during the evaluation.
When making the decision, under section 25 of the Therapeutic Goods Act 1989 on whether to register the medicine on the ARTG, the decision maker (the delegate of the Secretary of the Department of Health) will:
Once the decision is made we will send you a written notification of the decision (Step 12).
This step involves finalising the registration once a decision has been made on whether to register an OTC medicine.
If the decision is to register the medicine, we will send you the decision letter.
This letter will include decisions made by the delegate of the Secretary to impose standard and specific conditions on the registration of your medicine in the register, under Section 28 of the Therapeutic Goods Act 1989.
It is important that you read, understand and comply with these conditions.
If you do not comply with any one of these conditions of registration, your medicine may be cancelled from the ARTG under section 30(1)(da) of the Act.
You need to provide a patent certificate under subsection 26B(1) of the Therapeutic Goods Act 1989 or notification that this is not required before the medicine can be registered on the ARTG.
If you have not already provided the patent certificate or notification form with your application, complete either the:
Send us the completed and signed notification form or certificate by email (contact us), quoting the application submission number.
Once we receive the completed and signed notification form or patent certificate:
The registration of your medicine will commence on the day specified in the certificate of registration. The medicine cannot be lawfully imported, exported or supplied by the applicant prior to this date.
If the decision is not to register the medicine, the decision letter will include both:
Only some OTC medicines have approved PI/CMI documents. Sponsors may choose to publish these on the PI/CMI search facility on the TGA website.
Title changed from 'OTC new medicines registration process' to 'Understanding application requirements for over-the-counter medicines' as part of migration to new 'Guidance' content type:
Update to Step 12 of the process to include information on publishing PI/CMIs on the TGA website.
Update to step 3 and step 8 of the process to reflect the new OTC fee structure commencing on 1 January 2016.
Original publication
Replaces ARGOM Guidelines on pre - market application and evaluation process for OTC medicines v1.3 09/04/2014.
Title changed from 'OTC new medicines registration process' to 'Understanding application requirements for over-the-counter medicines' as part of migration to new 'Guidance' content type:
Update to Step 12 of the process to include information on publishing PI/CMIs on the TGA website.
Update to step 3 and step 8 of the process to reflect the new OTC fee structure commencing on 1 January 2016.
Original publication
Replaces ARGOM Guidelines on pre - market application and evaluation process for OTC medicines v1.3 09/04/2014.
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