Applicant Details
Applicant Name
The Applicant Name is automatically generated form the Sponsor or Agents name who logged into TGA's web site. This name cannot be changed.
Sponsor Name
The name of the Sponsor or Agent who has logged into the Web site. The name is selected from a drop-down list and the list only pertains the logon details.
Sponsor's Address
The Sponsor or Agent's address who has logged into the Web site. The address is selected from a drop-down list and the list only contains the information pertaining to the logon details.
Sponsor's Preferred Billing Address
The Sponsor or Agent's mailing address. The address is selected from a drop-down list and the list only contains the information pertaining to the logon details.

Application Details
Application Status
There are two different status for the application, these statuses are automatically generated by the lodgement process:
Draft When an application has first been created; and
Validated When the application has met all mandatory requirements and the validation process completed..
Application Type
Select an entry from the drop-down list that pertains to the application you wish to submit to TGA.
Type of Submission to be included in
Select a category from the drop-down list:
Category 1: If a sponsor is supplying evidence from Australian organisations to support their submission
Category 2: If a sponsor is supplying evidence from an overseas organisation to support their submission

Provisional Record Details
Label Name
Trade Name, Generic Name, Strength, Dosage form, or Container Type. Enter the information directly into the field to a maximum of 150 characters.
Is the formulation of this product confidential from the Sponsor
If the product information is confidential select the Yes radio button.
Are the manufactures of this product confidential from the Sponsor
If the manufactures of this product are confidential select the Yes radio button.
Is the formulation of this product confidential from Agent
If the product is confidential select the Yes radio button
Are the manufactures of this product confidential from Agent
If the manufactures of this product are confidential select the Yes radio button
Biological/Non-biological
Select Biological if the product in which the active ingredient is a biological substance including antisera, antivenins, monoclonal antibodies and products of recombinant technology.
Select Non-biological if the product is synthetic
Proposed Therapeutic Indications
Add any therapeutic indications information directly into the text field. This field is limited to 4000 characters.
Dosage form
The dosage form for the medication can be either selected from the drop-down list or manually typed into the field. If you manually type the information directly into the field, a warning message displays on the form stating that the information was not selected from the code tables. Reword this entry as per Keith's instructions!!!!

Route of Administration
To add a route of administration

1. Click the Add button
2. Select a route of administration from the drop-down list
3. Click the Insert button

If an entry has not been selected from the drop-down list, a warning is displayed that the entry was not selected from the code tables.
You can add multiple entries by following the above steps.
To remove an entry

1. Click the box(s) in front of each item to removed
2. Click the remove button

A question box is displayed asking you to confirm that you wish to delete the selected item(s).
Container Type
The container is a vessel, bottle, tube, ampoule or other similar article that immediately covers the goods. Select the container type from the drop-down list. If you manually enter the information into the field, a warning message is displayed advising that the contents was not selected from the code tables
Container Material
Select the container material from the drop-down list. If you manually enter the information into the field, a warning message is displayed advising that the contents was not selected from the code tables
Visual Identification Dosage Form
Information is entered directly into the field and limited to a maximum of 150 characters
ATC Code
Select the ATC Code from the drop-down list
Printed product material supplied
To add printed product material

1. Click the Add button
2. Select an item from the drop-down list
3. Click the Insert button

You can add multiple entries by following the above steps.
To remove an entry

1. Click the box(s) in front of the item to removed
2. Click the remove button

A question box is displayed asking you to confirm that you wish to delete the selected item(s).
Is this product supplied sterile
A Yes No selection. If you select Yes, a Sterility Details box is added to the form.

Sterility Details
To add Sterility Details

1. Click the Add button
2. Add information regarding the Sterilised Part in the text box if required
3. Select a sterility method from the drop-down list
4. Click the Insert button

If an entry has not been selected from the drop-down list, a warning is displayed that the entry was not selected from the code tables.
You can add multiple entries by following the above steps.
To remove an entry

1. Click the box(s) in front of the item to removed
2. Click the remove button

A question box is displayed asking you to confirm that you wish to delete the selected item(s).

Ingredients
The Ingredient name is the AAN (Australian Approved Name) for pharmaceutical substances.
To add Ingredients

Existing Ingredient New Ingredient Existing Ingredient Enter the Ingredient Name by selecting the Search button Select the Ingredient Role Select how you wish to search for the Ingredient by: Name Enter the Ingredient Name Proprietary Ingredient by ID Enter the Proprietary Ingredient ID Select the Search button Select the Ingredient from the Search Results list Click the OK button Select the Quantity Units from the drop-down list Ingredient Quantity Enter the Ingredient Quantity Ingredient Quantity Range Enter the Ingredient Quantity Range From: To: Add any Additional Ingredient Information Click the Insert button

To remove an entry

1. Click the box(s) in front of each item to removed
2. Click the remove button

A question box is displayed asking you to confirm that you wish to delete the selected item(s).

Pack Size and Poison Schedule
Size of the goods in terms of the quantity contained in the container and / or the number of items in the primary / unit pack (for example, number of tablets in a bottle).
To add Pack Size and Poison Schedule

1. Click the Add button
2. Add information regarding the Pack Size in the text box
3. Select the Poison Schedule by clicking the drop-down arrow and making a selection from the list below
4. Click the Insert button

You can add multiple entries by following the above steps.
To remove an entry

1. Click the box(s) in front of the item to removed
2. Click the remove button

A question box is displayed asking you to confirm that you wish to delete the selected item(s).

Shelf Life

1. Select a proposed shelf life from the drop-down list
2. Select the proposed storage temperature from the drop-down list
3. Select the proposed storage conditions from the drop-down list
4. Add additional information directly into the text box if required. This field is limited to a maximum of 500 characters

Manufacturer
A corporation or person carrying out one or more of the following steps: : produce the goods; or to engage in any part of the process of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of the process.
To add Manufactures details

1. Click the Add Manufactures button
2. Select if the Manufacturer is an Existing Manufacturer or a New Manufacturer

Existing Manufacturer New Manufacturer Existing Manufacturer Click the Search button to find an existing Manufacturer Select Manufacturer Australian Select how you wish to Search Using Overseas The Search Using is defaulted to Clearance ID Enter the search details matching the search using in the text box Click the Search box Select the appropriate search results from the Number of entries found list The Id: is automatically populated Click the OK button Select the Manufacturing Steps multiple steps can be selected Select the Manufacture Location from the drop-down list if there are multiple locations for the selected Manufacturer The location address is automatically populated Click the Insert button

To remove an entry

1. Click the box(s) in front of the item to removed
2. Click the remove button

A question box is displayed asking you to confirm that you wish to delete the selected item(s).