You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Completing the online application form for RCMs

Print version

ARGCM Part D: Registered complementary medicines

29 October 2017

Help

Fields in the application form

The information below will assist you in providing the required information for completing (and submitting) an online application for a Registered Complementary Medicine (either for new ARTG entries or changes to existing ARTG entries).

  • Ensure you complete ALL fields, indicating 'nil or 'not applicable' if required.
  • Simple fields (e.g. phone numbers) will not have any further explanation in this guidance.
Open all | Close all
If you want to print all details, you need to Open all before you print.

This field is pre-populated based on the TBS logon ID used.

Select address recorded in TBS for this sponsor (drop-down list).

Select address recorded in TBS for this sponsor (drop-down list).

Contact for this application.

This defaults to 'Create a new ARTG entry' when you first begin.

If you are changing a current ARTG entry, selecting this button will open additional fields for you to complete.

These use the 'RCM' application type:

  • RCM1: An application for a fragrance/flavour/colouring variant of a fully evaluated originator medicine.
    If your application type is RCM1

    In this case, an additional field (Parent) will appear requiring you to select the AustR number of the fully evaluated parent medicine.

    Screenshot of the RCM1 application type highlighting the Parent AUST R search box

    Searching and selecting the relevant parent medicine will create a new draft copy of the application, based on the details of the parent medicine.

  • RCM2: An application for a medicine which complies with a RCM monograph, as described in the guidance documents.
  • RCM3: For complementary medicines where previous evaluation by TGA (or comparable regulatory authority) has demonstrated their safety and efficacy.
  • RCM4: For complementary medicines where one or two out of quality, safety and efficacy has been established.
  • RCM5: For new complementary medicines to be registered on the ARTG that have not been previously evaluated to demonstrate quality, safety and efficacy.

These use the 'C' application type, and will be classified as C1 to C4 depending on requirements.

After you select Change a current ARTG entry, enter the ARTG number of the entry you want to change in the Licence to Change field. Then select the Search button.

Screenshot of Non-Prescription Medicine application highlighting the Change to a current ARTG entry Licence to Change search box

New Changes fields will then appear in the Application tab.

Screenshot of Changes field

Select the Add button to begin adding changes. This will open the Change Detail window.

Select the relevant Change Category from the drop down list (in this example, Labelling and product detail changes).

Screenshot of Change Detail highlighting Change Categorie

Next, select the Change Type from the drop down list. (Note: the list will only contain the change types relevant to the change category you selected).

Screenshot of Change Detail, Change Type field

When you select the relevant Change Type, the Description and Assurances fields will be populated with the relevant information, and you will be able to add comments.

Screenshot of Change Detail fields

If you want to add another change category, select the Save button to add the change to the Changes list (on the main form), and then select another change category to start adding another change. Once you have added all the desired changes, select Save && Close to go back to the main form.

Screenshot of Changes - Add and Remove tabs

Exemption from payment is only available upon application. Please send your request to complementary.medicines@health.gov.au.

Registration details tab

For a new registration application, enter the proprietary name as it appears on the product label. For a change application, only amend this field if proposing a change to the proprietary name.

To add export names, select the Add button, which will then display a free text box to insert the export name.

Screenshot showing where to add export names.

If you want to enter more than one name here, select Save to add each one to the list. When you have entered the last (or only) name, select Save & Close to return to the main form.

Manufacturer details tab

Note: For change applications, this tab will be pre-populated with the details of the ARTG entry you wish to change.

To add manufacturers, select the Add button, which will then display a box to insert more specific manufacturer information.

Screenshot showing where to add manufacturer details.

Once you have successfully searched for the relevant manufacturer, another information box will appear. All fields in this box are required.

Screenshot showing fields for manufacturer details.

For the manufacturer name and site, the details will be pre-populated, but other selections may be possible using the drop-down lists in these fields. Please confirm the details are correct.

Once complete, select Save á Close to add the details to the Manufacturers list.

To remove manufacturers, simply select the check box next to the entry you wish to delete, and select the Remove button.

Product details tab

Note: For change applications, the fields in this tab will be pre-populated with the information from the ARTG entry you've selected to change.

The proposed indications for the medicine (which will be used in the ARTG if approved).

Include details here if your product contains an additional appliance, e.g. a measuring device.

To add a dosage form, you can either select a route from the drop down list, or begin entering your proposed route, which will then display a filtered list of possible options from the available list.

Screenshot showing how to add the dosage form.

What you enter here must be consistent with the description of the medicine's visual appearance (visual ID), as specified in the medicine's Finished Product Specifications document, e.g.:

  • white, circular, biconvex tablets

To add a route of administration, select the Add button in this section, which will open a drop down list.

Screenshot showing where to add route of administration.

You can either select a route from the drop down list, or begin entering your proposed route, which will then display a filtered list of possible options from the available list.

Screenshot showing how to add route of administration.

Yes or No.

If Yes, go to the next section Method(s) of Sterilisation and select the relevant methods from the drop down list. You can also begin entering the sterilisation method which will then display a filtered list of possible options.

If No, the default requirement for Method(s) of Sterilisation will be removed.

Screenshot showing how to add method(s) of sterilisation.

To add the product's ingredients, select the Add button in this section, which will then open the Ingredient selection/search box.

Screenshot showing how to add ingredient details.

For each ingredient to be added to the Ingredients list, you'll need to complete the following process:

  1. In the Ingredient selection/search box, select the appropriate combination of Formulation Type and Ingredient Role.
  2. Select to search by name or proprietary ingredient ID.
  3. Enter either:
    1. the Ingredient Name you wish to search
    2. a proposed ingredient name
  4. If you are searching for an ingredient name, enter your search term and select the Search button. This will open the Ingredient details box, and all fields are required.
Screenshot showing fields for ingredient details.

If a component needs to be added, select the Add button in the Component section. This will open the Add Equivalent search box to either search for a component, or enter a proposed component name.

Screenshot showing how to add a component.

When searching for a component (in this example, pollen), you can enter either a full or partial term to search.

Screenshot showing how to search for a component.

Once your component name is selected, enter the quantity of the component.

If you want to enter more than one component here, select Save to add each one to the list. When you have entered the last (or only) component, select Save & Close to return to the Ingredient details box.

Then, select Save & Close in the Ingredient details box to add the ingredient to the list.

Select the container type from the drop-down list.

(We have used vial for this example.)

Select the Add button to open the Product Container and Shelf life details box.

Enter details for:

  • Container material
  • Container closure
  • Container condition
  • Product shelf life
  • Product storage conditions
  • Additional shelf life information
Screenshot showing fields for product container and shelf life details.

If you want to enter the details of more than one container, select Save to add each one to the list. When you have entered the last (or only) container, select Save & Close to return to the main form.

Select the Add button to open the Pack Size and Poison Schedule details box.

Screenshot showing where to add pack size and poison schedule details.

Pack size: Select the Help button if you need any information on pack size.

Poison schedule: Select the appropriate entry from the drop down list.

Note: If you want to enter the details of more than one pack size/schedule, select Save to add each one to the list. When you have completed the last (or only) entry, select Save & Close to return to the main form.

Supporting information tab

Supporting data/information should be attached (preferably) as a single zipped file (individual file sizes are limited to 100 Megabytes).

For further explanation on this, select the Help button within the Attachment details pop-up box.

Screenshot showing where to add supporting information.

Enter the title of the document.

Selecting the Browse button will open Windows Explorer on your computer, which then allows you to search and select the relevant file to upload.

Select Save & Close to attach the file to your online application.

Select this option if you intend to provide your supporting information separately to this form (e.g. on CD).