General guidelines for naming biological ingredients
A wide range of substances have been identified as biological substances in the Ingredients Table.
In some instances, common names have been chosen as these are more readily understood, for example 'honey bee venom'. The Latin binomial species name is then included as a synonym, for example 'Apis mellifera venom'.
All microorganisms must be named using the Latin binomial species name, for example Streptococcus salivarius.
In the past, some products themselves have had a biological ingredient name. For example, 'pertussis vaccine' (a product). This approach is no longer in place. In this example, the approved biological name for the ingredient is Bordetella pertussis.
Referring to animal species
Approved biological names for animal-based ingredients should use the scientific name, not the common animal name.
For example:
- bovine (cow)
- ovine (sheep)
- canine (dog)
- feline (cat)
- porcine (pig)
- equine (horse)
The common name (cow, etc.) can be included as a synonym to improve searchability of the Ingredients Table.
Naming specific types of biological ingredients
Naming microorganisms
Microorganisms are generally identified to species level. Subspecies and biovar names are only included where proven to be therapeutically relevant.
To avoid proliferation of multiple strain names, the strain reference can only be used in the ingredient name if identification of an individual strain:
- is therapeutically relevant
- if therapeutic activity is exclusive to the particular strain
- can be otherwise justified.
Information about strains may be included as additional information in an entry in the Ingredients Table. Medicine labels can include strain information, as long as this information is presented in accordance with the relevant labelling order.
Naming animal parts and preparations
To provide an accurate description of animal derived substances, the approved name for biological ingredients will incorporate
- part
- preparation
- source details
rather than as adjunct names (as is done for herbal ingredients).
Bovine cartilage powder and snake venom powder are examples of biological substances of animal origin.
Transmissible Spongiform Encephalopathies (TSEs)
The animal source and part is information that we use to evaluate the safety of the substance with respect to transmissible spongiform encephalopathies (TSEs). The animal source and part will not be used separately as names in their own right.
Further information on our TSE policy (and which ingredients are eligible for self-assessment) can be found in Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure.
Ingredients of animal origin to be used in listed medicines
For TSE safety, new ingredients of animal origin that are used in listed medicines must be pre-cleared before they can be added to the Ingredients Table.
Naming biological ingredients of human origin
If a biological substance is of human origin, the origin of the substance is not specified in the name.
For example, the biological substance 'calcitonin' refers to the human protein, whereas 'porcine calcitonin' and 'salmon calcitonin' are obtained from pigs and salmon respectively.
Cell and Tissue substances
Contact us for guidance on naming cell and tissue based substances.