TGA use only
ARTG number:

This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <http://www.tga.gov.au/about/tga-information-to.htm>.

Notification of a new proprietary ingredient

  • Please refer to the Guide to the Completion of the ‘Notification of a New Proprietary Ingredient’ form (the Guide), to ensure that this form is correctly completed. Where a question number (e.g. 1) appears on the form, a corresponding note is given in the Guide.
  • In making this application to enter a Proprietary Ingredient on to the Australian Register of Therapeutic Goods (ARTG), the sponsor agrees to the Therapeutic Goods Administration (TGA) making available in the TGA’s Electronic Listing Facility (ELF) any 'restricted ingredients’ and the quantity (if the restriction is based on quantity) or the conditions applying to use of that ingredient (if conditions apply) contained within this Proprietary Ingredient. Please refer to the Guide for further details.
  • The partially completed form should be sent to the supplier of the Proprietary Ingredient, for completion.
  • The completed form and any attachments should be sent to:

Proprietary Ingredient Coordination Unit
Non-Prescription Medicines Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
AUSTRALIA

  • For more information, telephone 02 6232 8465.

Please provide an estimate of the time taken to complete this form.

Include:

  • The time actually spent reading the instructions, working on the question and obtaining the information; and
  • The time spent by all employees in collecting and providing this information.

hours: / mins

Part A – General details

1. This notification is part of an application for:

  • Listing of an Export Only Medicine
  • Listing of a Medicine for supply in Australia
  • Registration of a Medicine via Non-Prescription Medicines Branch
  • Registration of a Medicine via Drug Safety Evaluation Branch
  • Notification of a proprietary sub-ingredient of a proprietary ingredient
  • Listing of a Therapeutic Device
  • Registration of a Therapeutic Device
  • Unknown at the time of application

2. Registration/Listing name of goods of which the Proprietary Ingredient is an ingredient:

3. Route of administration of goods of which the Proprietary Ingredient is an ingredient:

4. Sponsor’s business name:

5. Sponsor’s business address:

6. Sponsor’s contact person/agent:

Name:
Postal address:
Phone: / Fax:
Email:

7. Sponsor’s client identification (ID) number (if known):

8. Proprietary ingredient supplier’s business name:

9. Proprietary ingredient supplier’s business address:

10. Proprietary ingredient supplier’s contact officer:

Name:
Postal address:
Phone: / Fax:
Email:

11. Proprietary ingredient supplier’s client ID number (if known):

12. Have you attached a completed ‘Client details’ form for this information?Yes: No:

Part B – Product details

13. Proprietary ingredient name:

14. This Proprietary Ingredient is intended for use as a: (please tick one of the following)

Note: Refer to Appendix 1 of the Guide for definitions

  • Active Pre-mix 1
  • Adhesive 2
  • Flavour 2
  • Ink 2
  • Fragrance (perfume)
  • Capsule Shell Formulation
  • Coating Material
  • Colour 3
  • Cream (Ointment) Base 3
  • Excipient Mix 3
  • Oral Base 3
  • Preservative Mix 3
  • Sweetener 3

Notes:

1.It is mandatory for active pre-mixes to contain at least one active ingredient and for ingredients to be in valid names consistent with the Australian Approved Terminology for Medicines (i.e. AAN, ABN, AHN or PRV). Quantitative data must also be provided for all ingredients. If the formulation is to be used in a Listed medicine, all ingredients must be listable for the proposed route of administration of the finished product.

2.It is NOT mandatory for these ingredients to be in AAN format, however sponsors are strongly encouraged to provide names in AAN format, if they are known. It is NOT mandatory to supply quantitative details for these ingredients.

3.It is mandatory for these ingredients to be in valid names consistent with the Australian Approved Terminology for Medicines (i.e. AAN, ABN, AHN or PRV) and that quantitative data be provided for all ingredients.

Part C – Formulation details

15. Total number of ingredients contained in Proprietary Ingredient formulation:

16. Please supply information on all ingredients in your Proprietary Ingredient formulation, including details of the role and quantity of each ingredient, as outlined below: (Attach additional pages as required)

Role of Ingredient
(Active or Excipient) / Name of Ingredient / Quantity/Units

TGA use only

17. Number of Sub-Proprietary Ingredients listed for this Proprietary Ingredient:

Note: Sub-Proprietary Ingredients are those ingredients whose formulations have not been or will not be revealed to you by your supplier(s).

18. Please supply the following information on all Sub-Proprietary Ingredients of this Proprietary Ingredient: (Attach additional pages as required)

Sub-proprietary ingredient name: / Quantity/Units:
Proprietary Ingredient ARTG number (if known): / Supplier’s client ID No. (if known):
Name of supplier:
Sub-proprietary ingredient name: / Quantity/Units:
Proprietary Ingredient ARTG number (if known): / Supplier’s client ID No. (if known):
Name of supplier:
Sub-proprietary ingredient name: / Quantity/Units:
Proprietary Ingredient ARTG number (if known): / Supplier’s client ID No. (if known):
Name of supplier:

19. Have you sent ‘Client details’ form to Sub-Proprietary Ingredient supplied for which no Client ID number is given? Yes: No:

20. Have you sent a partially completed ‘Notification of a New Proprietary Ingredient’ form to the suppliers of Sub-Proprietary Ingredients for which no ARTG number is given? Yes: No:

Part D – Additional information on proprietary ingredients

21. Are any of the ingredients contained in the formulation not currently included in the ARTG? (A response to this question is not required if the proprietary ingredient is to be used as an adhesive, flavour, ink or fragrance). Yes*: No: Unsure**:

* You are required to submit supporting toxicological data. Please contact the Proprietary Ingredient Coordinator on 02 6232 8465 to arrange submission of data.

** You may be required to submit supporting toxicological data. Please contact the Proprietary Ingredient Coordinator on 02 6232 8465 to determine your obligation in this regard.

Note: Evaluation of toxicological data attracts a fee. If, during the processing of this notification it is discovered that the formulation contains ingredients that are not currently included in the ARTG, you will be required to submit supporting toxicological data for evaluation by the TGA. The proprietary ingredient notification cannot be finalised until the toxicological data has been evaluated and found to be acceptable by the TGA.

TGA use only

22. Are any ingredients derived from human or animal origin? Yes*: No:

* If Yes, you may be required to complete and attach a ‘Pre-clearance application for animal- derived ingredients’ (with any required supporting documents). If you are unsure as to your obligation in this regard, please contact the Proprietary Ingredient Coordination Unit on
02 6232 8465. A copy of the pre-clearance application form is available on the TGA website at: <http://www.tga.gov.au/industry/cm-forms-animal-derived-ingredients.htm>

23. Are any ingredients derived from endangered species? Yes*: No:

* If yes, provide details:

Note: The TGA may be required to release this information to Environment Australia.

Part E – Manufacturer details

24. Manufacturer’s name:
25. Manufacturer’s site address:
26. Manufacturer’s client ID No. (if known):

Notification of a proprietary ingredient (August 2014)Page 1 of 8
For official use only