Notification of a new proprietary ingredient

Purpose

The proprietary ingredient notification form is for suppliers of ingredient mixtures, such as flavours or fragrances, who do not wish to disclose the mixture's formulation details (such as ingredient quantities) to sponsors of the therapeutic goods on the Australian Register of Therapeutic Goods (ARTG).

This form allows the TGA to enter formulation details and other relevant information into the Proprietary Ingredient Table in TGA Business services (TBS). Once processed, a unique name and number is generated for each proprietary ingredient mixture. This PI number can be selected by sponsors when they make an application to enter new therapeutic goods on the ARTG.

This process is optional - suppliers do not need a PI number to allow their product to be used in the formulation of a medicine or medical device. The therapeutic goods sponsor can individually select the ingredients within the mixture when submitting their medicine, medical device or biological application.

Once a therapeutic good is entered on the ARTG, some information about the ingredients in its formulation is displayed in the public summary of that entry. This includes some details of any proprietary ingredient mixtures used in the goods. For more information go to proprietary ingredient formulations and how they are used.

Changes to your proprietary ingredient

To ensure that our records are accurate, suppliers must inform the TGA of changes to the proprietary ingredient (e.g. change to supplier details or if the mixture is no longer being supplied).

To maintain the integrity of information within the Proprietary Ingredient Table, where a supplier has changed their product's name or formulation we will not update the existing Proprietary Ingredient entry. If you wish to include your changed product in the Proprietary Ingredient Table, a new notification is required and will result in a new PI number. The only exception to this is where a proven error occurred when the ingredient mixture was originally entered in the Proprietary Ingredient Table.

Using proprietary ingredient mixtures in therapeutic goods

Sponsors of therapeutic goods must ensure that their product meets all requirements for listing, registration or inclusion on the ARTG. Suppliers of proprietary ingredients may need to provide information about their ingredient mixture to therapeutic goods sponsors to assist them in meeting these obligations.

Listed Medicines

If a proprietary ingredient mixture is proposed for use in listed medicines, all ingredients within the formulation must be included in the Therapeutic Goods (Permissible Ingredients) Determination and meet those requirements. This includes the declaration of mandatory components of specific ingredients.

For information about how to include ingredients in the Determination, see Applications for new substances in listed medicines or Australian regulatory guidelines for sunscreens (ARGS) for listed sunscreens.

Other requirements

Further information on regulatory requirements for ingredients and substances proposed to be used in therapeutic goods is available below:

• Colourings used in medicines for topical and oral use
• Substances that must be declared on medicine labels as specified in Schedule 1 of the labelling Orders:
  • TGO 91 - Standard for labels of prescription and related medicines and
  • TGO 92 - Standard for labels of non-prescription medicines
• Restricted ingredients used in listed medicines Regulation 11 of the Therapeutic Goods Regulations 1990
• Required Advisory Statements for Medicine Labels (RASML) for ingredients
• Restrictions applicable to ingredients - Ingredients table on TBS
• Animal derived ingredients - Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure
• Access controls on substances - Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

See ingredients in therapeutic goods for further information about ingredients and contact details for enquiries.

PI Form

Submit your completed form to TGAnames@tga.gov.au.