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Guidance on the evaluation process and information required for new registered complementary medicines.
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This guidance assists applicants who wish to either:
This guidance replaces the archived document ARGCM V8.0 Part D Evaluation of registered complementary medicines.
Registered medicines are considered to be of higher risk than listed medicines based on their ingredients and/or the therapeutic indications they carry. Medicines must be registered on the ARTG where one or more of the following applies:
Prior to being approved for entry in the ARTG, registered medicines are subject to critical assessment by the TGA to determine whether the proposed medicine meets the requirements for quality, safety and efficacy.
AUST R registered complementary medicines are eligible to include a TGA assessed claim on their medicine label and other advertising material indicating that the TGA has assessed the evidence the sponsor holds for the medicine’s indications. The use of the TGA assessed claim is optional for the product sponsor – refer to TGA assessed claim for assessed listed and registered complementary medicines.
Information required for a registered complementary medicine applicationInformation required for a registered complementary medicine application
Schedule 10 of the Therapeutic Goods Regulations 1990 (the Regulations) prescribes which area within the TGA conducts the evaluation of specific therapeutic goods. Part 2 of Schedule 10 states that complementary medicines that do not meet the criteria for inclusion in Schedule 4, 8 and 9 of the Poisons Standard are evaluated by the Complementary and OTC Medicines Branch.
Important: Where a medicine is/would be subject to Schedules 4, 8 and 9 of the Poisons Standard it will be evaluated as a prescription medicine - refer to Australian Regulatory Guidelines for Prescription Medicines.
In some circumstances, we may refer an application to the Prescription Medicines Authorisation Branch for evaluation to ensure an appropriate level of evaluation is applied to a medicine commensurate with its level of risk. These include medicines that meet one or more of the following criteria:
If an application is referred to an alternative registration pathway, we manage the application according to the requirements (for example: fees, process, data requirements and evaluation time lines) of the new evaluation process.
Registered complementary medicines may be subject to the conditions of a schedule (not Schedules 4, 8 and 9) or an appendix of the Poisons Standard, for example:
It is important that you consider possible scheduling requirements before submitting an application for registration - refer to the Principles of Scheduling in the Poisons Standard and the AHMAC - Scheduling policy framework for medicines and chemicals. The decision to include a medicine in a schedule takes into consideration toxicity, the purpose of use, potential for abuse, safety in use and the need for the substance.
If you are unsure of potential scheduling of your proposed medicine you should seek advice from the TGA.
Registered complementary medicine applications are categorised according to complexity. There are five levels for applications to register a complementary medicine (RCM 1 to RCM 5).
Each of these levels corresponds to an application category. Applications in lower levels require less supporting information and have lower fees and reduced timeframes compared to applications in higher levels.
Descriptions and examples of the five categories for registered complementary medicines applications are provided below.
An RCM1 application is an application made under section 23 of the Act to register a complementary medicine that is identical to another registered complementary medicine (the parent medicine1) other than differences between presentation, colour, flavour or fragrance.
The guidance document for OTC new medicine N1 applications, ‘Permitted differences for the parent medicine', is applicable for RCM1 applications.
For data requirements for RCM1 applications refer to Mandatory requirements for an effective registered complementary medicine application: Appendix A-Specific mandatory requirements.
An RCM 2 is an application made under section 23 of the Act to register a complementary medicine for which the evaluation of the safety, quality and efficacy of the medicine is based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction [comparable overseas body(COB)] determined under regulation 16GJ.
Important: COB evaluation reports that are provided for RCM 2 applications must be from a list of COBs that is determined by the TGA under Regulation 16GJ – see List of COBs for registered complementary medicines, assessed listed medicines and substances for use in listed medicines.
For data requirements for RCM 2 applications refer to Mandatory requirements for an effective registered complementary medicine application: Appendix A-Specific mandatory requirements.
An RCM 3 application is an application made under section 23 of the Act to register a complementary medicine, where:
In comparison to the fully evaluated (not grandfathered) parent medicine, the proposed generic medicine must have the same:
Note: Generic complementary medicines applications that require submission of bioequivalence data are category RCM 4.
For data requirements for RCM 3 applications refer to Mandatory requirements for an effective registered complementary medicine application: Appendix A-Specific mandatory requirements.
An RCM 4 is an application made under section 23 of the Act to register a complementary medicine, where one of the following applies:
For data requirements for the different types of RCM 4 applications refer to Mandatory requirements for an effective registered complementary medicine application: Appendix A-Specific mandatory requirements.
Refer to Tables 1 and 2 for examples of RCM 4 applications.
| Example of RCM 4 | Further considerations | Conditions |
|---|---|---|
| New therapeutic indication | Only if grouping does not apply. If grouping applies, refer to Changing a registered complementary medicine: Application levels and change tables | Must not result in a change in the target population |
| Wider target population | A reduction in the class of person for whom the goods are suitable is considered a C1 change (change code GDS) | - |
| Decrease in the strength | Determined per dosage unit | - |
| New directions for use | For example, change in recommended daily dose | Only if grouping does not apply. If grouping applies, refer to Changing a registered complementary medicine: Application levels and change tables |
| Medicines requiring a PI and CMI | Applications requiring a PI and CMI are considered RCM 4 or RCM 5 applications; as a minimum Module 4 and Module 5 data are required | - |
| Example of RCM 4 | Further considerations |
|---|---|
| Generic medicine application requiring bioequivalence data | Excluding enteric-coated tablets and capsules |
| Generic modified-release dose forms | Excluding enteric-coated tablets and capsules |
| Deletion of an active ingredient | - |
| RCMs using active ingredients permitted for use in listed medicines with higher level indications | - |
A RCM 5 application is made under section 23 of the Act to register a complementary medicine where the application is not an RCM category (1 to 4) and one of the following applies:
For data requirements for the different types of RCM 5 applications refer to Mandatory requirements for an effective registered complementary medicine application: Appendix A-Specific mandatory requirements.
All applications for evaluation of a registered complementary medicine attract an application and evaluation fee – refer to current fees.
Regulation 16GH of the regulations provides for legislated timeframes for evaluation of registered complementary medicines. There are different evaluation timeframes for each of the five application categories. While the TGA is required to complete the assessment within the specified timeframes, applicants should not presuppose the outcome of an application. The timeframes for evaluation of registered complementary medicines are provided in Table 3.
| Category | Description | Notification of preliminary assessment (working days) | Evaluation timeframe (working days) |
|---|---|---|---|
| RCM1 | An identical medicine to another registered complementary medicine other than differences between presentation, colour, flavour or fragrance. | 40 | 45 |
| RCM2 | Evaluation of the safety, quality and efficacy of the medicine is based on evaluation reports from a COB | 40 | 90 |
| RCM3 |
| 40 | 150 |
| RCM4 |
| 40 | 180 |
| RCM5 |
| 40 | 210 |
Within 40 working days of receiving an application, the TGA delegate of the Secretary will notify the applicant in writing, whether the application has passed preliminary assessment.
The evaluation timeframes for registered complementary medicines:
If the Secretary does not make a recommendation within the evaluation timeframe, the TGA must refund 25% of the prescribed evaluation fee.
The General dossier requirements provides guidance for applicants to meet the general information requirements for an application for evaluation of a new registered complementary medicine.
The Common Technical Document (CTD) sets out the format for an application when applying to register a medicine in the ARTG. The Mandatory requirements for an effective registered complementary medicine application describes the information, consistent with the CTD format, that must be submitted to the TGA in order for an application to register a complementary medicine to be considered effective and proceed to evaluation.
The CTD specifies the organisation of the information across 5 modules so they are grouped logically and can be easily located:
The actual content of the dossier for a RCM application will vary according to the application category (RCM 1 to 5). Appendix A - Specific mandatory requirements of the Mandatory requirements for an effective registered complementary medicine application specifies the data requirements for each RCM application category.
Module 1 of the CTD has been tailored to accommodate the needs and requirements for complementary medicines. Refer to CTD Module 1: Administrative information for registered complementary medicines - Guidance for applicants and CTD modules 2, 3, 4 and 5 for registered complementary medicine applications - Guidance for applicants’ for more information. The Data requirements matrix for new RCM applications is a useful tool for sponsors that provides a summary of the CTD modules required for each new registered complementary medicines application category.
If you are unable to submit a full CTD dossier, the minimum structural requirement for registered complementary medicine dossiers consists of a single pdf document for each module. To maintain this structure, organise the document content using the CTD headings (combination of module number and module name).
There are 14 steps in the application process for evaluation of a registered complementary medicine application.
If you have already determined your product is a complementary medicine that you wish to register, and you have a client ID number and password to access TGA Business services, go to Step 2.
To verify you have a complementary medicine for registration in the ARTG, go to the section entitled ‘What are complementary medicines’ in General guidance for listed medicines.
Related information and guidance
Applications are created and lodged through TGA 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 a complementary medicine you need to make sure its active ingredients are designated active ingredients only (Schedule 14 to the Regulations provides a list of designated active ingredients for complementary medicines).
If the formulation contains at least one non-complementary medicine active ingredient your medicine will be evaluated via an alternate pathway and you will need to follow the appropriate registration (OTC medicines or prescription medicines).
Check whether the ingredients in the medicine are included in the following tables under Public TGA Information on the business services homepage:
Important: These code tables only provide the approved name or synonym for the ingredient. Inclusion of the name in the code tables does not mean we have approved the ingredient for use in therapeutic goods.
You will need the proprietary ingredient ID number to complete your application and to register the medicine in Step 9.
If the proprietary ingredients are new (not in the Code tables), submit the completed Notification of a Proprietary Ingredient form to obtain a proprietary ingredient ID number. You will be issued a proprietary ingredient ID number.
If your registered complementary medicine contains a substance that is new, you will need to propose a name for it. To do this:
You also need to check if your complementary medicine is subject to the conditions of a schedule (excluding Schedules 4, 8 and 9) or an appendix of the Poisons Standard.
Medicines may be subject to the conditions of a schedule or an appendix of the Poisons Standard, for example:
Important: Consider possible scheduling requirements before submitting an application.
If you are unsure of potential scheduling of your medicine, you can contact Complementary medicines.
You will need valid evidence that the manufacturer(s) of your complementary medicine have applied Good Manufacturing Practice (GMP) for each step of manufacture. To ensure this you will need:
We cannot finalise your application without current and valid GMP clearance (issued by the TGA) for each overseas manufacturer. You need to ensure that the GMP clearance will not expire during the evaluation timeframe.
If the GMP clearance is due to expire within the minimum timeframe or is likely to expire before the application is finalised:
We recommend renewing the GMP clearance for applications with a target evaluation time exceeding 6 months rather than seeking extension of the GMP clearance because 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 GMP clearance, state this in the application cover letter.
Related information and guidance
There are 5 application categories to register a new complementary medicine based on complexity, with category 1 being the lowest and category 5 being the highest.
The data requirements and evaluation timeframes increase with the level of assessment and risk mitigation required, so it is important that you determine the application category correctly.
To help determine the correct application category, see Application categories for registered complementary medicines.
If your application does not include the data required for its application category, your application may not pass preliminary assessment and may be refused under section 23B of the Therapeutic Goods Act 1989.
When planning your application to register a complementary medicine, you will need to identify and understand the relevant technical and regulatory requirements and guidelines.
Use the following guidance to prepare your dossier of supporting information in Step 7. It will assist you to compile a complete application to pass preliminary assessment in Step 11 and progress to evaluation in Step 12.
Related information and guidance
Ensure you check:
- TGA assessed claim for assessed listed and registered complementary medicines
- Complementary medicine presentation
- The relevant European Union and ICH guidelines adopted in Australia for any specific requirements that apply to your application
- Therapeutic Goods Orders
Need assistance?
If you have read the guidance and need our assistance, please contact Complementary medicines.
Exemption to use a restricted representation on the label
You will need an advertising exemption if you are using a restricted representation on your medicine label.
You can include your request for an exemption in your application to register your medicine.
To do this:
Include this application in Module 1.2.5 Form for approval to use a restricted representation.
Restricted representations
Please note that approval for the use of a restricted representation can only be considered once the complementary medicine is registered in the ARTG.
General requirements for your dossiers
Compile your electronic dossiers (includes Module 1 and the technical modules) according to the general dossier requirements.
Dossier format
Compile the technical information consistent with the Mandatory requirements for an effective registered complementary medicine application.
Data requirements
Use the Mandatory requirements for an effective registered complementary medicine application: Appendix A-Specific mandatory requirements and the data requirements matrix tool in CTD modules 2, 3, 4 and 5 for registered complementary medicine applications to identify the data you will need for your application category.
Make sure you submit all relevant data in the modules you need for your application category. Provide justifications as to why any data is omitted and discuss with us at the pre-submission meeting in Step 8.
Guidance for applications to be effective
Check to ensure your dossier:
We will assess whether the application is effective during preliminary assessment in Step 11.
If your application is incomplete or deficient, we will refuse ineffective applications during preliminary assessment and it will not progress to evaluation.
We recommend you arrange a pre-submission meeting with us prior to submitting your application for a new registered complementary medicine. This will assist you to submit a high quality and complete dossier.
Discussion will focus on the structure of your proposed application, the identification of critical issues and the suitability of your proposed approach.
We do not:
To arrange a meeting, follow the guidance on pre-submission meeting with TGA.
Include the meeting record in CTD Module 1.7 Compliance with meetings and pre-submission processes.
Note that our guidance at the meeting is nonbinding and without prejudice. As knowledge evolves over time, the initial guidance we gave at the meeting may become out of date or be superseded.
In this step, you complete the application form and submit your application to register a complementary medicine.
How to complete the application form
To complete and submit your registered complementary medicine application, follow the instructions in: Registered complementary and OTC medicines application and submissions.
Submission ID number
You will be automatically issued a submission number, which uniquely identifies the application.
Use this submission number in all future communications about the application.
Monitoring the application progress
You can monitor the workflow status of your applications through Business Services.
Use the sponsor portal and the menu option ‘View lodged submissions’, under the column ‘Workflow Status’.
The application start date is the date that the fees are processed.
Withdrawing an application
You can withdraw an application at any time up until the decision is made.
You can use Business Services to withdraw an application. Follow the instructions in Registered complementary and OTC medicines application and submissions.
Alternatively, you can advise us in writing of your intention to withdraw the application.
If the application is withdrawn due to safety issues, we may ask you to provide any adverse safety data.
Important: When an application is withdrawn, we may retain the application and any material submitted in connection with the application.
Refund when an application is withdrawn
We will:
When you apply to register a complementary medicine, we will invoice you for both the application fee and the evaluation fee together. The fees are based on the application category. If the application does not pass preliminary assessment, the full evaluation fee will be refunded.
For details of the current fees, go to Summary of fees and charges.
Invoicing the fees
You will automatically receive an invoice when you submit the application.
Important: 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 may need to adjust the evaluation fee from that invoiced at the time of submission if:
We will assess the evaluation fee during preliminary assessment (see Step 11) and, if necessary, we will issue:
Waive or reduce evaluation fees
Paying the fees
For information on fees and the available payment methods see:
Making payments by cheque
If you are paying the application fees by cheque:
TGA Finance
PO Box 100
WODEN ACT 2606
Australia
Do not:
Paying additional evaluation fees
You will need to pay any additional evaluation fees in full within 2 months of the date of the invoice or the following will occur:
We will conduct a preliminary assessment of your application to verify it meets both the administrative and technical eligibility requirements to proceed to evaluation.
Within 40 working days of receiving an application, the TGA delegate of the Secretary will notify the applicant in writing, whether the application has or has not passed preliminary assessment.
What makes an effective application
Your application will pass preliminary assessment (is effective) if it meets the requirements under section 23B of the Act. This means:
We rely on information in your application cover letter (refer to CTD Module 1: Administrative information for registered complementary medicines) to confirm the application category and corresponding data requirements.
Effective applications
If your application passes preliminary assessment, we will notify you in writing:
The evaluation process will not commence until you have paid the evaluation fee in full.
Opportunity for minor corrections
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 mentioned in the application we will give you an opportunity to provide the attachment.
Ineffective applications
If your application does not pass preliminary assessment (is ineffective), we will:
You will forfeit the application fee.
Note that this notice is an administrative action and not an ‘initial decision’ within the meaning of Section 60 of the Act i.e. this decision cannot be appealed.
If you reapply to register the medicine, 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.
Lapsing applications
Your application will lapse if evaluation fees are not paid within two months of becoming payable. We will notify you that your application has lapsed.
You will need to submit a new application and pay the application fee to register the medicine.
Once your application has passed preliminary assessment and the evaluation fee has been paid, your application will progress to the evaluation phase. We will undertake the evaluation and may request information under Section 31 of the Act. The timeframe for evaluation is based on the application type - refer to Timeframes and fees for evaluation of registered complementary medicines above.
During evaluation of your application, we will:
Quality data
We evaluate the quality of the medicine, including the identity, impurities and stability of all ingredients and take into account information about:
Safety data
Our assessment of safety data includes:
Efficacy data
We assess efficacy data to determine whether it supports the indication(s)/claim(s) including:
Presentation of the medicine
We assess all aspects of the medicine presentation, including for compliance with the various legislative requirements (including advertising requirements) and to ensure clarity for consumers in relation to the medicine and its proposed use. This includes:
Requesting information
We may request you to provide information to clarify or address issues that we identify during the evaluation. During this time, the evaluation clock will stop.
We make these requests for information under section 31 of the Act and include a timeframe for you to respond. The time between the RFI being issued and receipt by the TGA of the applicant's response will not be counted as part of the evaluation timeframe (i.e. the 'evaluation clock' will stop).
Evaluators may also seek clarification of minor issues on an informal basis. The clock will not stop in these circumstances.
Responding to requests for information
It is important that you provide complete and accurate information.
Preparing your response
If the request for information relates to the content of a module of the submission dossier:
Due date for responding to requests for 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 register the medicine (in Step 13) based on available information.
Unsolicited information
We do not evaluate unsolicited information or data, unless it is:
Expert advisory committee advice
We may decide to seek advice from an expert advisory committee, such as the Advisory committee for complementary medicines (ACCM). We will inform you about:
The advisory committee process will typically extend the evaluation timeframe.
Related information
Before the delegate makes a decision on whether to register a complementary medicine, you may need to verify the details of the application, including any changes during the evaluation.
Matters considered before making a decision
When making the decision under section 25 of the Act on whether to register the medicine in the ARTG, the decision maker (the delegate of the Secretary of the Department of Health) will:
We will send you a written notification of the decision.
This step involves finalising the registration once a decision has been made on whether to register the medicine.
Decision to register the medicine
If the decision is to register the medicine, we will send you the decision letter. This letter will include standard and specific conditions on the registration of your medicine under Section 28 of the Act. 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.
The decision letter will also request you to provide assurance that all details of the medicine are correct before we create the ARTG entry.
Related information and guidance
Patent certification under the Australia/USA free trade agreement
You need to provide a patent certificate under subsection 26B(1) of the Act, or notification that this is not required before the medicine can be registered in the ARTG. If you have not already provided the patent certificate or notification form with your application, complete either the:
Send the completed and signed notification form or certificate by email to complementary.medicines@health.gov.au quoting the application submission number.
Registering the medicine and your ARTG certificate
Once we receive the completed and signed notification form or patent certificate:
Date of effect of the registration
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.
Annual charges
Annual charges will apply once the medicine starts generating turnover.
Related information and guidance
Decision not to register the medicine
If the decision is not to register the medicine, the decision letter will include a statement of the reasons for the decision and information on your rights to seek a review of the decision.
For information: Applicants for a new registered complementary medicine can appeal the Secretary’s decision about that application under section 60 of the Act. Refer to Guidance for requesting reconsideration of an initial decision.
Section 28 of the Act provides a number of conditions of registration that automatically apply when a medicine is registered in the ARTG. Failure to comply with a condition of registration may result in the cancellation of the medicine from the ARTG. Statutory conditions of listing are displayed in a medicine’s ARTG certificate.
Section 28 of the Act provides legislative powers for the Secretary to impose, vary or remove additional conditions on all registered therapeutic goods at the time the medicine is registered, or any time thereafter.
To apply for approval to make a change to your medicine, use the online application form for registered complementary medicines. Refer to Registered complementary and OTC medicines application user guide.
Where the same change is made across a number of products an individual application form is required for each product entry sought to be varied. Applicable fees are required to be paid for each product varied.
Refer to:
Title changed from 'Applications for registered complementary medicines' to 'Submitting an application for a registered complementary medicine' as part of migration to new 'Guidance' content type:
V1.0
This document, ‘Submitting an application for a registered complementary medicine’ has been extracted from the archived document ARGCM v.8 April 2018 pages 99 -238 (previously named ‘ARGCM Part D).
The sequence of information, headings and formatting have been amended from the original content for consistency, accuracy and easier navigation. References to outdated forms have been removed.
Technical content has been extracted to the following standalone guidance document:
New guidance has been included on changes to the regulatory framework for listed medicines, including:
Title changed from 'Applications for registered complementary medicines' to 'Submitting an application for a registered complementary medicine' as part of migration to new 'Guidance' content type:
V1.0
This document, ‘Submitting an application for a registered complementary medicine’ has been extracted from the archived document ARGCM v.8 April 2018 pages 99 -238 (previously named ‘ARGCM Part D).
The sequence of information, headings and formatting have been amended from the original content for consistency, accuracy and easier navigation. References to outdated forms have been removed.
Technical content has been extracted to the following standalone guidance document:
New guidance has been included on changes to the regulatory framework for listed medicines, including:
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