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Part 1 - Applicant and agent details
Applicant details
How to complete this information
Record the information requested in the spaces provided.
Provide a postal address where this differs from your street address.
What else do I need to do?
The applicant will become the sponsor of the product once the application is approved. Please enter the name and client ID of the sponsor.
If you do not have a client ID, apply for a client ID through TGA Business Services by completing an Organisation details form before lodging your application.
Ensure the nominated contact person is available throughout the evaluation process, to respond to any questions the TGA may have.
If the contact persons or the contact information changes during the pre-submission/evaluation processes, contact the TGA at nonprescriptionmedicines@health.gov.au and advise of the change.
Agent details
How to complete this information
Complete this section only if you are an agent acting on behalf of the applicant/company seeking approval for the product.
Record the information requested in the spaces provided.
What else do I need to do?
If you do not have a client ID, you will need to apply for a client ID through TGA Business services before lodging your application. You will need to ensure that the applicant has authorised you to act on their behalf through TGA Business Services.
Part 2 - Application category
Application type
Select one of:
- New product: a product which is not yet listed in the ARTG.
- Variation to existing product: a product which exists in the ARTG that requires change to the listing.
Three application categories for assessed listed medicines
Select the category relevant to the application.
Applications for assessed listed medicines are categorised into three levels, based on risk and have different fees and evaluation timeframes.
It is important that you determine the correct application level.
It is important to ensure that you select the correct application category for your application in order to ensure that it can be accepted for evaluation. The application categories and specific requirements for each category are set out in the Assessed listed medicines evidence guidelines.
If your application does not include the required data, in accordance with the application level, it will not be accepted for evaluation under subsection 23B(6) of the Therapeutic Goods Act 1989.
Checking guidelines and mandatory requirements
When planning your assessed listed medicine application you will need to identify and understand the relevant mandatory requirements and guidelines.
Check the Assessed listed medicines evidence 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 pass preliminary assessment and be accepted for evaluation:
- Mandatory requirements for an effective assessed listed medicine application; and
- CTD Module 1: Administrative information for assessed listed medicines
How to complete this information:
For L(A)1 applications:
- Select either 'yes' or 'no' to indicate whether the originator medicine has been fully evaluated for efficacy by the TGA.
- Provide the ARTG number for the reference medicine.
For L(A)2 or L(A)3 applications:
- Select either 'yes' or 'no' to indicate whether your application is a literature based submission.
- Select either 'yes' or 'no' to indicate the types of efficacy data you have included in your dossier submission.
- If your application is missing data, select the checkbox to indicate a justification is included in module 5 of your dossier submission.
Part 3 - Product details
How to complete this information:
Enter the product details in the spaces provided.
Refer to the TGA approved terminology for medicines guidance to find the appropriate terminology.
| Field | Description |
|---|---|
| ARTG number | For variation applications only. Enter the AUST L(A) number of the medicine being varied. |
| Label (product) name | This is the name of the product which will appear on the label and final ARTG listing. |
| Dosage form | Enter the dosage form for the medicine. The dosage forms accepted for listed medicines are provided in Attachment 1. |
| Route(s) of administration | Enter the route(s) of administration. The following routes of administration are accepted for listed medicines:
|
| Visual identification of dosage form | Enter the description of the medicine's visual appearance (visual ID). What you enter here must be consistent with the information specified in the medicine's Finished Product Specifications document, e.g.: white, circular, biconvex tablets. |
| Maximum daily dose | Enter the maximum daily dose. If the dosage form is non-dividing (for example: powder), enter the units. |
| Maximum single dose | Enter the maximum single dose. If the dosage form is non-dividing (for example: powder), enter the units. |
| Weight of divided preparation | Only required when using a divided dosage form (for example: tablet) and the formulation contains restricted ingredients. |
| Pack size (optional) | Enter the pack size(s). Separate by a comma if multiple pack sizes are being supplied. |
| Container details: Container type, volume, closure, condition, material | Only required when the formulation contains ingredients which have been restricted to a 'container type', 'closure' or 'size limit'. If applicable, for products containing restricted ingredients:
Select and enter the container condition:
Enter the container material |
| Storage details | Enter the storage details for the product. |
| Shelf life (time and temperature)(optional) | Enter the shelf life of the product (time and temperature). |
3.1 Formulation details
What to include:
- download the separate Module 1.2.1 Assessed listed medicine general application information form
- complete the form as instructed below
- include the form in Module 1.2.1 of your submission dossier.
Single or multi-active ingredients
Check the box to indicate whether your medicine formulation contains a single active ingredient or multi-active ingredients.
Composite packs
A 'composite pack application' is used for medicines that are to be sold together in one package, where the medicines are either combined before use or administered in a particular sequence, for a single treatment or course of treatment. For the full definition of a composite pack, refer to section 7B of the Act.
'Composite pack applications' differ from general assessed listed medicines applications only in that they require the addition of multiple formulations.
To submit a composite pack application:
- Check the box to indicate whether your medicine is a composite pack.
- For each formulation in your composite pack, include the formulation details separately using the format outlined below.
Formulation details
All ingredients (active and excipients) contained in an assessed listed medicine must be included in Therapeutic Goods (Permissible Ingredients) Determination and the formulation must be compliant with any restrictions or requirements associated with those ingredients.
An application which contains ingredients which are not in the permissible ingredients determination will not be accepted for evaluation.
You can search for the ingredient via the catalogue of permitted ingredients. The ingredient summary provides guidance on acceptable uses of an ingredient and any associated restrictions.
Tick yes or no to indicate whether all ingredients in the medicine formulation are:
- Permitted for use in listed medicines
- comply with the requirements for their use in listed medicines
All formulation details must be provided in your submission dossier.
Refer to the table below for the information required for active and excipient ingredients.
| Field | Description |
|---|---|
Active ingredients Excipient ingredients | Enter the name of the ingredient as listed in 'Ingredient Name' in the Ingredient Summary sheet. (Enter the ingredient equivalent details, if required) Equivalent: There are two instances where equivalents are used:
|
| Category | Enter the appropriate ingredient category acronym from the following: AAN - Australian Approved (Chemical Substance) Name ABN - Australian Biological Name AFN - Australian Food Name AHN - Australian Herbal Name AHS - Australian Herbal Substance HCN - Herbal Component Name |
| Quantity | Ingredient quantities are required for all active ingredients. Excipient ingredient quantities are currently not required unless they are AHNs or have restrictions. Enter the ingredient quantity (for homeopathic ingredients, enter potency) |
| Units | Enter the units for the ingredient (for homeopathic ingredients, enter diluent details) |
| Restrictions | Tick yes or no to indicate whether the ingredient has any restrictions for use. |
Requirements for Australian Herbal Name (AHN) ingredients details (if applicable)
Further information is required to support your application if the product contains an AHN ingredient.
If your product contains an AHN ingredient, refer to the table below for the information required to support your application.
| AHN Only | Description |
|---|---|
| Plant part | Enter the plant part. |
| Plant preparation | Enter the plant preparation. |
| Equivalent preparation | Enter the appropriate equivalent preparation, if required. |
| Equivalent quantity | Enter the amount of equivalent preparation to be used in the ingredient, including the units. |
| Final preparation ratio | Enter the final preparation ratio. |
| Remaining Restricted Solvent | Required if solvents are restricted. The solvent to be added must be the same as those used in preparation steps previously completed. Residue Quantity: The upper limit (maximum amount) of solvent allowed in the specifications for the ingredient. |
| Carrier | A carrier is an excipient ingredient which may be included in a herbal ingredient. Press the 'Add' button to add a carrier to the ingredient. Multiple carriers can be added. |
Proprietary ingredients details (if applicable)
Additional information is required to support your application if the product contains a proprietary ingredient.
Formulation details of 'Proprietary Ingredients' are not released and usually contain either multiple excipient ingredients or a single active preparation which may also include excipient ingredients.
'Active Proprietary Ingredients' require ingredient quantities to be entered. Some excipient 'Proprietary Ingredients' such as flavours, fragrances and printing inks also require quantities to be entered, as the following limits apply to the final formulation:
- Flavour - 5%
- Fragrance - 1%
- Printing Ink - 0.1%
If your product contains a proprietary ingredient, refer to the table below for the information required to support your application.
| Proprietary ingredient | Description |
|---|---|
| Proprietary ingredient name | Enter the name of the ingredient as listed in 'Ingredient Name' in the Ingredient Summary sheet. |
| Proprietary ingredient ID | Enter the proprietary ingredient ID as listed in 'Ingredient Name' in the Ingredient Summary sheet. |
| Formulation type | Enter the formulation type as listed in Ingredient Name' in the Ingredient Summary sheet. |
| Ingredient role | Enter the ingredient role as listed in 'Ingredient Name' in the Ingredient Summary sheet. |
| Ingredient type | Enter the ingredient type as listed in 'Ingredient Name' in the Ingredient Summary sheet. |
| Quantity | Quantity Enter the ingredient quantity. Ingredient quantities are required for all active ingredients. Excipient ingredient quantities are currently not required unless they are AHNs or have restrictions |
| Units | Select the appropriate unit. |
| Equivalent | There are two instances where equivalents are used:
|
Ingredients of human or animal origin details (if applicable)
This is applicable to AAN or ABN ingredients.
Ingredients with potential viral and Transmissible Spongioform Encephalopathies (TSE) risks must be approved before their inclusion in listed medicines. Refer to the TGA's website for the Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure. Information on clearance of risk for TSE must be held by the sponsor in support of your application.
Tick 'yes' or 'no' to indicate whether all ingredients in the medicine formulation contain ingredients of human or animal origin.
Complete the fields below with information about the human or animal origin ingredients in the product.
| Ingredients of Human or Animal Origin | Description |
|---|---|
| Name of ingredient | Applicable to AAN or ABN ingredients. Note: A preclearance certificate issued by the TGA's Scientific Evaluation Branch may be required. Include the pre-clearance code here also, if applicable. |
| Animal species | Enter the animal the ingredient is derived from. |
| Animal part | Enter the part of the animal from which the ingredient is derived. |
| Country of origin | Enter the country, or countries, of origin for the ingredient from the drop down list. |
3.2 Manufacturer details
What to include:
- download the separate Module 1.2.1 Assessed listed medicine general application information
- complete the form as instructed below
- include the form in Module 1.2.1 of your submission dossier.
The applicant should ensure that their manufacturing licence or GMP Clearance covers the manufacturing steps of the product type and dosage forms that are to be performed by each of the manufacturing sites.
Tick yes or no to indicate whether:
- All Australian manufacturers involved in the manufacture of the product have a current Good Manufacturing Practice (GMP) licence which is suitable for the product type and dosage form.
- All overseas manufacturers involved in the manufacture of the product have current GMP clearance which is suitable for the product type and dosage form.
All details of Australian and overseas manufacturers must be provided in your submission dossier.
Complete the field below with information about the manufacturer(s) of the product.
| Field | Description |
|---|---|
| Name | Enter the full name of the manufacturer. |
| Licence/clearance number | If the manufacturer is Australian enter the Good Manufacturing Practice (GMP) licence number. If the manufacturer is overseas, the clearance ID number, if available. |
| Address | Enter the full address of the manufacturing site. |
| Manufacturing steps | Enter the steps performed by this manufacturer Note: the manufacturer must be licensed to carry out the manufacturing steps listed in the application. |
Part 4 - Indication(s) details
An indication means the specific therapeutic use of the medicine. There are two types of indications which can be added to an assessed listed medicine: 'Intermediate level' and 'Low level' indications. Advertising claims are not indications and do not need to be entered in the application and will not appear in the ARTG entry.
| Field | Description |
|---|---|
| Intermediate level indications | For your application to progress, it must contain at least one intermediate level indication. These indications exceed the criteria for low level indications but are still appropriate for listed medicines. Refer to the Assessed listed medicines evidence guidelines for more information on intermediate level indications. |
| Low level indications | Inclusion of low level indications is optional for assessed listed medicines. These indications are those appropriate for listed medicines, such as those specified in the list of permitted indications. You can access and search the list of permitted indications on the TGA Business Services website. |
Restricted representations
Tick 'yes' or 'no' to indicate whether your product indications refer to a restricted representation.
Part 5 - Submission details
Tick 'yes' or 'no' to indicate whether you have had a pre-submission meeting with the TGA concerning this application.
Part 6 - Fees
Ensure the fee paid is based on the application category.
Visit the following pages on the TGA website for more information about fees and payments:
Check a box to select your payment method.
Part 7 - Certification
The medicine that is the subject of the application must meet the requirements for each of the matters referred to in subsection 26AB(2) of the Act.
Check the box to certify that your medicine meets these requirements.
Part 8 - Declaration
What you need to do:
- Read the statements and conditions;
- Check the corresponding boxes; and
- Complete all remaining fields.
An application form will not be accepted unless it has been completed and is accompanied by a submission dossier.
Submitting an application form provides a declaration of understanding and agreement to satisfy the requirements for an effective submission.
Ensure the submission dossier contains the full data set to be evaluated.