This content is current only at the time of printing. This document was printed on 19 April 2018. A current copy is located at https://apvma.gov.au/node/26656
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This section of the application is where applicants enter the details of the active and non-active ingredients (constituents) in their product.
Applicants can opt to have their product’s manufacturer provide the formulation details directly to the APVMA, rather than complete this section. This supporting information needs to be provided to the APVMA prior to making an application or within seven days of submission.
Include information about all active and non-active ingredients in the formulation.
- Common or chemical names are required for the active constituent and other constituents.
- Trade names should only be used if common or chemical names do not exist. Purity details, as percentages, can be included, when appropriate.
For each immunobiological active constituent, list the:
- identity—such as the strain, genus, species and serotype/biotype
- common name standard—such as BP, EP, USP or other
- minimum release titre, maximum release titre and the shelf-life titre—such as x TCID50/dose, x EID50/dose or x pfu/mL, xpfu/dose.
Chemical Abstract Service (CAS) number
- List the (CAS) registry number for all constituents.
- If a CAS number has not yet been allocated for a constituent, state ‘not available’.
- Include the relevant APVMA active constituent approval number (eg 50001) for active constituents approved by the APVMA. Use our registered chemical products database to search for approved active constituents.
- Include the most recent standard (eg USP-NF2010) for constituents manufactured to an acceptable Compendial standard.
- Mark ‘MS’ when a constituent is manufactured to a manufacturer’s specification.
- Details about the manufacturer’s specification must be uploaded to the information list in the online application.
- In some cases, agricultural chemical Material Safety Data Sheets (MSDS) may be uploaded to the data and information section of your application instead of manufacturer’s specifications.
- Where an MSDS is submitted instead of a distinct specification, the APVMA will consider the specification within the MSDS as the valid standard, if appropriate.
- To protect trademarked information for non-active constituents, the supplier or manufacturer can email or post their specifications directly to the APVMA. This information needs to be provided to the APVMA prior to making an application or within seven days of submission.
Express concentrations in weight/unit—eg mg/tablet, g/L or g/kg. Include the nominal concentration for each constituent.
List the purpose for all active and non-active constituents in the formulation, such as surfactant, emulsifier, filler, binder, solvent, preservative.
Weight and specific gravity
- Include the total weight for solid formulations.
- List the specific gravity for liquid formulations and their total weight/volume.
Identify the type of formulation, such as pour-on, tablet, powder, wettable powder, paste or emulsifiable concentrate. Please see the guideline of formulation types for more information.
Animal spongiform encephalopathies
Select this checkbox if the product contains ingredients with a risk of transmitting animal spongiform encephalopathies.
Select this checkbox if the product contains any genetically modified organisms (GMOs). Ingredients derived from—or a by-product of—a GMO are considered by the APVMA to contain GMOs.
Select this checkbox if the product contains any material intentionally engineered to be less than 100nm in at least one dimension.