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Registration process for complementary medicines

Print version

ARGCM Part D: Registered complementary medicines

29 October 2017

This guidance is to assist applicants to register a complementary medicine on the ARTG.

This guidance:

  • identifies the regulatory process you need to follow
  • navigates you through the process step-by-step
  • links to relevant guidance and forms.

Steps to register a complementary medicine

You can skip Step 1 if you have already determined that you have:

  • a complementary medicine that you wish to register on the ARTG
  • access to TGA Business services.
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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.

Verifying you have a complementary medicine

To verify you have a complementary medicine for registration on the ARTG, go to What are complementary medicines?

Client identification and access to TGA Business services

Applications are created and lodged through TGA Business services.

You will need both of the following to make an application:

  • a Client ID number
  • password access to our Business services.

If you do not have a Client ID number or access to our business services:

Next step

Go to Step 2 - Checking ingredients and scheduling

Before you prepare your application to register a complementary medicine you need to make sure its active ingredients are designated active ingredients only.

If the formulation contains at least one non-complementary medicine active ingredient:

Checking for ingredient names in our tables

Check whether the ingredients in the medicine are included in our Tables under Public TGA Information on the business services homepage:

These code tables only provide the approved name or synonym for the ingredient.

It does not mean we have approved the ingredient for use in therapeutic goods.

New proprietary ingredients

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 (i.e. not in the Code tables), submit the completed Notification of a Proprietary Ingredient form to obtain a proprietary ingredient ID number.

We will issue you a proprietary ingredient ID number.

Proposing a name for new substances

If your registered complementary medicine contains a substance that is new, you will also need to propose a name for it. To do this:

Scheduling ingredients

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:

  • Schedule 2 – 'Pharmacy Medicine'
  • Schedule 3 – 'Pharmacist Medicine'.

Consider possible scheduling requirements before submitting an application.

Medicines with similar substances and indications are likely to be subject to similar schedules.

If a medicine contains a substance that requires scheduling control, and it is not already scheduled, we may classify the substance when making the registration decision.

If you are unsure of potential scheduling of your medicine, you can contact Complementary medicines.

Next step

Go to Step 3 - Ensuring valid GMP evidence

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:

  • For Australian manufacturers: a copy of a GMP licence issued by the TGA
  • For overseas manufacturers: a GMP clearance issued by the TGA.

Duration of GMP for overseas manufacturers

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.

As part of the Government's complementary medicine reforms, TGA will be consulting on target assessment timeframes for registered complementary medicines in late 2017.

GMP clearance that is due to expire

If the GMP clearance is due to expire within the minimum timeframe or is likely to expire before the application is finalised:

  • Before you submit the application, you need to either:
    • apply to renew the GMP clearance
    • seek an extension to the GMP clearance expiry.

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.

Guidance to complete this process

Next step

Go to Step 4 - Determining your application category

There are 5 categories for applications to register complementary medicines based on risk, with category 1 being the lowest and category 5 being the highest risk.

The data requirements and target evaluation times 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, we may not accept it for evaluation under section 23(2)(b) of the Therapeutic Goods Act 1989.

As part of the Government's complementary medicine reforms, TGA will be consulting on application category types for registered complementary medicines in late 2017.

Next step

Go to Step 5 - Checking relevant guidelines and requirements

When planning your application to register a complementary medicine, you will need to identify and understand the relevant technical and regulatory requirements and guidelines.

Guidance for effective applications

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 the screening in Step 11 and progress to evaluation in Step 12.

Technical document modules

For guidance on information needed for the evaluation of quality safety and efficacy, see:

Relevant guidelines

Ensure you check:

Need assistance

If you have read the guidance and need our assistance, contact Complementary medicines.

Next step

Go to Step 6 - Requesting exemptions as part of your application

Exemption to use a restricted representation on the label

You will need an 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 on the ARTG.

Next step

Go to Step 7 - Compiling data for your application

General requirements for your dossiers

Compile your electronic dossiers (includes Module 1 and the technical modules) according to the general dossier requirements and the data requirements matrix.

Dossier format

Compile the technical information consistent with the data requirements matrix, noting some parts may not be relevant for your application.

The dossier is divided into five modules:

  • Module 1 for complementary medicines
  • Module 2 summaries of quality, safety and efficacy
  • Module 3 Quality
  • Module 4 Safety (non-clinical study reports)
  • Module 5 Efficacy (clinical study reports).

Further information on CTD modules can be found on the TGA website.

The minimum requirements for registered complementary medicine dossiers are:

  • Single PDF document for each module
  • PDF documents must be text searchable and either bookmarked or hyperlinked
  • CTD heading and numbering must be used in each module.

Full or modified CTD dossiers may also be submitted.

The dossier format can be discussed with us at the pre-submission meeting (Step 8).

Data requirements

As part of the Government's complementary medicine reforms, TGA will be consulting on data requirements for registered complementary medicines in late 2017.

Follow the data requirements matrix to identify the data you will need for your application category.

The following guidance will help you to compile the data needed for each CTD Module:

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:

  • is complete
  • is in the required format
  • includes the information required for an evaluation of quality, safety and efficacy
  • includes your application cover letter.

We will check whether the application can be accepted for evaluation during screening in Step 11.

If your application is incomplete or deficient, we will not accept it and it will not progress to evaluation.

Next step

Go to Step 8 - Arranging a pre submission meeting

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:

  • assess or evaluate as part of a pre-submission meeting.
  • charge a fee for a pre-submission meeting.

To arrange a meeting, follow the guidance on pre-submission meeting with TGA.

Include the meeting record in Module 1.7 Compliance with meetings and pre-submission processes.

Next step

Go to Step 9 - Completing and submitting your application

In this step, you will be completing the application form and submitting 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 within:

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 Using the online RCM application form. 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.

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:

  • refund the evaluation fee if the application is withdrawn before it enters the evaluation step in the process
  • not refund the application fee.

Next step

Go to Step 10 - Paying your fees

When you apply to register a complementary medicine, we will invoice you for both the application fee and the evaluation fee together.

For details of the current fees, go to Schedule of fees and charges.

Invoicing the fees

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 may need to adjust the evaluation fee from that invoiced at the time of submission if:

  • the application contains clinical or toxicological data for evaluation—that is, a higher evaluation fee applies, based on page count
  • we grant your request to waive or reduce the evaluation fee.

We will assess the evaluation fee during screening (see Step 11) and, if necessary, we will issue:

  • an invoice, for any additional fees that apply
  • a refund, if we waive or reduce the evaluation fee.

Waive or reduce evaluation fees

  • In some circumstances, we may be able to waive or reduce the evaluation fee (not the application fee) under Regulation 45 of the Therapeutic Goods Regulations 1990.
  • Check these regulations to see if you are eligible for a waiver or reduction in evaluation fees.
  • Once you have checked, if you then think you may be eligible include a request and justification in the application cover letter.
  • We will make a decision prior to accepting the application for evaluation.

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:

  • indicate in the covering letter that payment has been forwarded to TGA Finance.
  • forward payment, together with a copy of the relevant invoice, by separate post to:

    TGA Finance
    PO Box 100
    WODEN ACT 2606
    Australia

Do not:

  • include cheque or credit card details with the submission.

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:

  • the application will lapse (section 24(2)(a) of the Therapeutic Goods Act 1989) and will not be evaluated
  • you will forfeit the application fee.

Next step

Go to Step 11 - Screening your application

We will screen your application to verify it meets both the administrative and technical requirements.

What makes an effective application

Your application is effective if it meets the requirements under section 23(2) of the Act. This means:

  • The prescribed application fee has been paid.
  • The application includes all information required, for the correct application category, to enable us to make a decision.
  • Applications for restricted medicines[4] include a form for providing product information that is approved under section 7D of the Therapeutic Goods Act 1989 (section 23(2)(ba) of the Act).
  • Samples of the medicine have been delivered to the TGA (only if requested).

We rely on information in your application cover letter to confirm the application category and corresponding data requirements.


Footnote

  1. Defined in the Restricted Medicine Specification 2011 and include prescription medicines (see Schedules 4 and 8 of the current Poisons Standard) and medicines that are only available from a pharmacist (Schedule 3 of the current Poisons Standard).

Screening checks

The screening checks aim to identify at the outset whether your application is effective.

Ensure you:

  • complete all required fields on your application form
  • have paid the applicable fee
  • provide sufficient information in your dossier
  • choose the appropriate pathway for evaluating your medicine.

Effective applications

If your application is effective, we will notify you in writing regarding both:

  • the acceptance of your application for evaluation
  • the applicable evaluation fee, if it differs from what you have paid on application.

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 is ineffective, we will:

  • not accept it for evaluation
  • remove your application from Business services
  • write to you and explain why the application is ineffective
  • refund the evaluation fee.

You will forfeit the application fee.

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 a new application if you wish to register the medicine.

Next step

Go to Step 12 - Evaluating your application and requesting information

During this step in the process, to register a complementary medicine, we will undertake the evaluation and may request information under Section 31 of the Act.

During evaluation of your application, we will:

  • evaluate the data and information on the quality, safety and efficacy and presentation of the medicine
  • review your responses to our requests for information
  • document our findings.

Evaluation target timeframes

We are implementing target timeframes for evaluating registrable complementary medicines.

As part of the Government's complementary medicine reforms, TGA will be consulting on target assessment timeframes for registered complementary medicines in late 2017.

Quality data

We evaluate the quality of the medicine, including the identity, impurities and stability of all ingredients and take into account information about:

  • The manufacturing processes and the compliance with GMP.
  • Quality-controls to determine if the quality of the medicine will be consistent.
  • Stability data to confirm the medicine is of appropriate quality over its proposed shelf–life.

Safety data

Our assessment of safety data includes:

  • history of use
  • pharmacology and pharmacokinetics
  • drug interactions
  • toxicology
  • clinical trials
  • reports of adverse reactions.

Efficacy data

We assess efficacy data to determine whether it supports the indication(s)/claim(s) including:

  • a detailed evaluation of the proposed indication(s)
  • any claims that you intend to make for the medicine.

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:

  • proposed labelling
  • Product Information and Consumer Medicine Information (when provided).

Requesting information

We may request you to provide information to clarify or address issues that we identify.

We make these requests for information under section 31 of the Act and include a timeframe for you to respond.

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.

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 the format described in step 7.

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.

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:

  • 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.

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 committee meeting and give you an opportunity to provide comment for the committee's consideration
  • any relevant advice from the committee.

The advisory committee process will typically extend the evaluation timeframe.

Next step

Go to Step 13 - The decision

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 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:

  • review all documentation associated with the application, including:
    • the application and submission dossier
    • the evaluation reports
    • responses to requests for information
    • advice from expert advisory committees
    • other relevant advice or information.
  • consider the matters detailed under section 25 of the Act, including whether the quality, safety and efficacy of the medicine have been established.

We will send you a written notification of the decision.

Next step

Go to Step 14 - Finalising your registration

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.

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 on 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.

Decision not to register the medicine

If the decision is not to register the medicine, the decision letter will include both:

  • a statement of the reasons for the decision
  • information on your rights to seek a review of the decision.