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Information for applicants completing a pre-submission planning form

Applicable to pre-submission planning forms lodged under the prescription medicines registration process from 1 May 2014

1 May 2014

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Part 2: Details of application

2.1 General information

Ingredients/proprietary ingredients

Are there any new non-proprietary ingredients, or proprietary ingredients in the application?

How to complete this information

Check if a non-proprietary ingredient is currently on the ARTG:

  • go to TGA eBusiness Services
  • click on 'Public TGA Information ' to expand the menu item
  • select 'Ingredients ' from the menu
  • to search the list, click the search button, enter the information to search, and click 'search'.

Check if a proprietary ingredient is currently on the ARTG:

  • go to TGA eBusiness Services
  • from the menu, open the twistie next to 'Public TGA Information'
  • select 'Proprietary Ingredients ' from the menu
  • to search the list, click the search button, enter the search information, and click 'search'.

If there are any new non-proprietary ingredients (active substance(s) and excipients) or proprietary ingredients in the application, check the Y box.

For each new proprietary ingredient, confirm with the supplier that they have lodged a notification of a proprietary ingredient with the TGA.

For each new non-proprietary ingredient, complete and lodge an application form to propose a new chemical, biological or herbal name (as appropriate) with the TGA. Attach copy/copies of the TGA 's acknowledgement letter(s).

Important note

Notification of a proprietary ingredient forms and applications for new chemical, biological or herbal names (for non-proprietary ingredients) must be lodged with the TGA before the PPF can be lodged.

Processing of the AAN/ABN/AHN applications will be expedited if the proposed name is registered as an international non-proprietary name (INN).

Ensure the proposed AAN, ABN, AHN and/or proprietary ingredient names are used in the dossier.

Are any of the excipients used for purposes other than that for which they are registered, for example, a new route of administration, or at an increased daily dose, or (for non-oral products) at an increased strength, compared with existing registered products?

If the other ingredients are intended to be used for a different purpose to that originally approved:

  • check the 'Y' box and
  • either:
    • upload an attachment containing an overview of the additional toxicology data that will be provided in the application to support the safety of the ingredient for the intended purpose, and check the relevant boxes at Part 2, Section 2.2, 2 - Summaries module and 4 - Nonclinical module to indicate which nonclinical documents are to be provided with the PPF
    or
    • provide an overview of the justification to explain why new toxicological data is not required to support the change in use, at Part 2, Section 2.3 - Justifications and further Information.

Fixed combinations

Does this product contain a new fixed combination of active ingredients?

How to complete this information

For new registrations, select the appropriate box to indicate whether the proposed product(s) is a new fixed combination.

If the proposed product(s) is a new fixed combination, attach a copy of the TGA's letter advising that the justification for fixed combination is acceptable.

What else do I need to do?

If applicants are applying to register one or more products containing a new fixed combination (i.e. a fixed combination of active substances that have not previously been included in the Register as that fixed combination), they will need to lodge a justification for a fixed combination with the TGA at least two months prior to PPF lodgement.

If applicants have not lodged a justification for a new fixed combination and attached a copy of the TGA's letter advising that the justification for fixed combination is acceptable, the PPF will be found to be non-compliant with section 23 of the Act.

Further information

Fixed combination requirements do not apply to new generic medicine, new strength, or variation applications.

See section 4.3.3: Fixed combination applications of Prescription medicine registration process for further information onlodging a justification for a fixed combination.

Fixed combination products may be presented as composite packs (i.e. with multiple dosage forms), multiple ingredients within a single dosage form, or a combination of both.

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