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Guidance on product changes in ELF3

31 August 2012

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Glossary

AAN - Australian Approved Name

ABN - Australian Biological Name

Active ingredients - the therapeutically active ingredients that are responsible for a physiological action.

AFN - Australian Food Name

AHN - Australian Herbal Name

AHS - Australian Herbal Substance: An AHS name is defined by a reference pharmacopoeial monograph or a compositional guideline and the AHS is prepared using the part plant and preparation method stated in the reference. Essential oils are often in this category.

Carrier - an excipient ingredient that is usually added to an active ingredient in the final dosage form and which assists with delivery of the active ingredient.

Claims - are the possible therapeutic uses of the product e.g. the product 'may help maintain wellbeing'. Claims and indications are mistakenly used interchangeably. Compare to Indications.

Code Stock - a stock formulation that can be sold to a number of sponsors, who then sell the product under their own brand name.

Component - a therapeutically active substance in an active ingredient. The component can be standardised or non-standardised to the active ingredient. Where the component is standardised to an active ingredient there must be compliance with the reference monograph or compositional guideline.

Excipient ingredients - Excipient ingredients - ingredients that are not therapeutically active and perform the functions of binding, colour, flavouring, filler etc.

HCN - Herbal Component Name

Indications - are the specific therapeutic actions of the product e.g. if one of the ingredients has a tradition of use for pain relief (as an anodyne), the indication could be 'may help reduce pain'. Claims and indications are mistakenly used interchangeably. Compare to Claims.

Maximum Recommended Daily Dose (MRD) - the total dose recommended to be taken in one day. The MRD is required if the formulation contains ingredients that are restricted by the daily dose.

Maximum Recommended Single Dose (MRS) - the MRS is required if the formulation contains ingredients that are restricted by a single dose.

Proprietary Ingredients (PI) - active pre-mixed ingredients or excipient pre-mixed ingredients that perform certain functions, such as film coating, or an empty capsule shell.

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