Notification of a new proprietary ingredient
The role of the 'Notification of a new proprietary ingredient' form is to allow the TGA to enter formulation details and other relevant information relating to a proprietary ingredient into the Proprietary Ingredient Table in TGA Business Services (TBS). This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number for each proprietary ingredient.
Applications for new therapeutic goods that are to be included on the Australian Register of Therapeutic Goods (ARTG) can then include these complex formulations in a single step using the allocated proprietary ingredient number (rather than the full formulation details of the proprietary ingredient).
Evaluation of a proprietary ingredient is not part of this notification process. Proprietary ingredients may be reviewed or evaluated when used in therapeutic goods.
Once a notification is processed, the proprietary ingredient will be searchable on the TBS Proprietary Ingredients Table. Information that identifies the proprietary ingredient is available for public view, for example, its name, number and all active ingredients.
If a proprietary ingredient is to be used in a listed medicine, all ingredients within the formulation must be included in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination) and meet the requirements of that Determination. Any ingredients not included in the Determination must be evaluated for use by the Complementary and Over the Counter Medicines Branch (COMB). If the ingredient is approved, it is included in the Determination before being made available for use in listed medicines. The Determination is updated quarterly.
Further information is available in the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part C for listed medicines or Australian Regulatory Guidelines for Over the Counter Medicines (ARGOM), Appendix 4, for listed sunscreens.
To allow correct upload of proprietary ingredient formulations into automated systems, quantities must be provided for all ingredients within the formulation. The exceptions to this are proprietary ingredients that are flavours, fragrances or printing inks, where quantities are not required. However, sponsors of goods that include proprietary ingredients must be aware of any restrictions that apply to any ingredient within the formulation to ensure that their goods are compliant with all regulatory requirements.
Sponsors and other users of proprietary ingredients should note the following:
- The inclusion of a proprietary ingredient in the Proprietary Ingredients Table in TGA Business Services does not imply any recommendation of its use in therapeutic goods.
- GMP requirements apply to proprietary ingredients that contain active ingredients.
- It is the sponsor's responsibility to ensure that all ingredients used in their proposed therapeutic good meet the requirements for listing, registration or inclusion of the goods on the ARTG. Please refer to the following information on the TGA website for more guidance:
- TGA approved terminology for medicines
- Colourings used in medicines for topical and oral use
- First Schedule to the labelling Orders: Therapeutic Goods Order No. 69 - General requirements for labels for medicines, TGO 91 - Standard for labels of prescription and related medicines and TGO 92 - Standard for labels of non-prescription medicines
- Regulation 11 of the Therapeutic Goods Regulations 1990 - restricted ingredients used in listed medicines
- Required Advisory Statements for Medicine Labels (RASML) for ingredients
- Ingredients table on TGA Business Services for approved ingredient names and restrictions applicable to ingredients
- Therapeutic Goods (Permissible Ingredients) Determination for use of ingredients in listed medicines
- Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure for animal derived ingredients
- Standard for the Uniform Scheduling of Medicines and Poisons.
For further queries contact:
Phone: 02 6232 8465
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