This content is current only at the time of printing. This document was printed on 29 November 2020. A current copy is located at https://apvma.gov.au/node/924
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Introduction to preparing a label and the label approval process
What is a label?
A label in relation to a product is the written, printed and related graphic matter on, or attached to, the container in which the product is directly packed and attached to the outside container or wrapper of the retail package, if there be any. Labels include tags, leaflets, brands, stamps, marks, stencils or written statements as well as such things as stickers. The label may often be the only source of information, instruction and advice to the user of a product.
A label must be attached to the container for the chemical product to which it relates before the product is supplied. A container includes anything by which or in which a chemical product is, or is to be, covered, enclosed, contained or packaged, but does not include a container (such as a shipping container) in which other containers of chemical products are, or are to be, placed for the purpose of being transported. The package (bag, can, bottle etc) in which a veterinary chemical product is packed and sold is the product’s container.
In cases where the size of a container precludes placement of all the necessary information on a single panel, the label can be divided into two or more parts (for example, a labelled container placed inside a carton that is also labelled, or a labelled container plus an inserted or fold-out leaflet or attached booklet). The ‘label’, in these cases, refers to a combination of all the parts. The label for the product is not complete until all of the parts are present and complete. In these cases, the possible label parts include:
- the primary pack—the outermost packaging in which the product is supplied (eg carton), or the immediate container, if there is no outer packaging
- the immediate container—the container that is in physical contact with the product (eg bottle, blister pack, syringe or bladder)
- a leaflet or booklet supplied with each single sale unit (where appropriate).
All information required on a label should be on the primary pack, if possible. If there is no outer pack (eg carton), the immediate container is the primary pack. Certain information may appear on a leaflet or booklet when space is limited.
A label or label part may be divided into a main panel and one or more ancillary panels. A panel refers to a distinct portion or division of the label. The main panel is the most prominent panel; it must contain the name of the product, signal heading (if required), active constituent statement, and other items in relation to the product. An ancillary panel (or panels) contains other information about the product, including its directions for use.
Every label for a product must be printed on or securely attached to the outside of the container or pack of the product. If leaflets or booklets are used, they should be attached to the container in plastic pockets or by other suitable secure holding methods.
When preparing a label, the designer should consider how to make the best use of the available space, what should be put into that space, and where to place the information within the space.
The APVMA must have regard to certain matters or details in order for it to satisfy itself that a label meets the labelling criteria and approve the label (sections 5D and 14 of the Agvet Code), Applicants must use the e-label template to submit the label details that the APVMA must take into account.
Other label content does not need to be assessed or approved by the APVMA and is not covered by the template (however all labels must comply with the relevant Labelling Code).
Changes to the information covered by the template can only be made by application for variation to the relevant particulars or conditions of the label approval. Changes to information not covered by the template may be made without formal APVMA approval but must remain compliant with the relevant Labelling Code.
The APVMA will consider the details submitted via the e-label template (that is, the proposed label wording) to ensure that the label meets the requirements set out in the agvet code and the agvet code regulations. (The information required in the template includes the adequate instructions required by section 5D of the agvet code, the relevant particulars and other information prescribed by the Agvet Code Regulations (regulations 8AE and 17), and any instructions or information required by the Agricultural or Veterinary Labelling Codes (regulation 18E). Note that the labelling codes include legislative requirements and guidance. Things required by the legislation are prefaced by the term 'must'.
If the wording submitted is complete and appropriate the APVMA will approve this wording. The agvet code now defines this as the ‘approved label’. Any changes to this wording require approval from the APVMA.
At the time a product is registered, or an active approved, the APVMA is required to publish information about it on the APVMA website—this includes some relevant label particulars. Publication of this information cannot be delayed.
Approval holders are required to incorporate the approved label wording in the labels placed on containers for chemical products for supply to the market. These labels may include other information provided that it is not contrary to the approved label wording. They must comply with the layout, presentation and legibility requirements of the relevant Labelling Code. This final version of the label is the 'marketed product label (MPL)'.
The term ‘relevant label particulars’ (RLP) has been used to describe the label details that the APVMA approves. To reflect the change in definition in the agvet code, the term 'approved label' will be used instead of 'relevant label particulars'. Note that there are still references to 'relevant particulars', which are a legally-defined component of the approved label.
The marketed product label must comply with all statutory conditions of label approval; for example:
- the label must be attached to the container for the chemical product to which it relates before the supply of the product
- the label must contain the distinguishing number, the instructions and particulars recorded in the relevant APVMA file (ie the approved label content)
- the label must contain the batch number, expiry date (if applicable) and date of manufacture (if applicable) of the chemical product, and the name and address of the person primarily responsible for marketing the product
- the label must not contain information that is contrary to any of the above, including the relevant particulars
- the information required on the label must not be altered, defaced, obliterated, obscured or destroyed
- the label must comply with the APVMA’s Labelling Standard or Labelling Code, whichever is in force at the time
- the label must not contain misleading or deceptive information
There are conditions that apply to the holder of the label approval, as follows:
- the holder of the label approval must not make any claims about the product that are inconsistent with an instruction on the label
- the holder of the label approval must retain a copy of each form of the label attached to a container (or series of containers) released for supply, together with records in relation to the batch number for the form of the label, and when the series of containers on which the form of the label is attached was first released for supply, for five years after the last supply of the product with that label
- the holder of a label approval must provide copies of the forms of labels and associated records to the APVMA on request.
the holder of a label approval must keep up-to-date the identifying information (essentially their contact details) for the holder of the approval and for any nominated agent.
Products covered by the Veterinary Labelling Code
This labelling code covers the labelling requirements for veterinary chemical products as defined in the Agvet Code. Any veterinary chemical product that requires registration may not become registered unless the APVMA also approves a label for container for the product. The Agvet Code Regulations may declare a substance or mixture of substances to be or not be a veterinary chemical product. The Agvet Code and the Agvet Code Regulations should be consulted to determine whether a product is a veterinary chemical product. Any chemical product that is a veterinary chemical product and requires registration by the APVMA is subject to the requirements of the Veterinary Labelling Code. If you are unsure whether a product is a veterinary chemical product, seek legal advice, use the veterinary-self-assessment-tool or contact the APVMA.
For requirements for agricultural chemical product labels, refer to the Agricultural Labelling Code.