This content is current only at the time of printing. This document was printed on 8 December 2022. A current copy is located at https://apvma.gov.au/node/90616
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Introduction to preparing a label and the label approval process – veterinary products
Veterinary chemical products and labelling requirements
When the Australian Pesticides and Veterinary Medicines Authority (APVMA) refers to veterinary products (also known as veterinary medicines), we mean those items that are defined by the Agricultural and Veterinary Chemicals Code (Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 as ‘veterinary chemical products'.
The Agricultural and Veterinary Chemicals Code Regulations 1995 (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. 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.
The APVMA cannot register a veterinary chemical product without also approving a label for containers for the product. Therefore, any chemical product that is a veterinary chemical product and requires registration by the APVMA is subject to the requirements of the Labelling Standard or, if there is no Labelling Standard, the Veterinary Labelling Code (VLC) made by the APVMA pursuant to regulation 18E(b) of the Agvet Code Regulations. The VLC is presented as a series of labelling requirements that cover the label content, presentation and layout of the approved and marketed labels.
For requirements for agricultural chemical product labels, refer to the Agricultural Labelling Code.
What is a label?
A label in relation to a veterinary chemical 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, as relevant. For our purposes, under section 3 of the Agvet Code labels include tags, leaflets, brands, stamps, marks, stencils or written statements. The label may often be the only source of information, instruction and advice to the user of a product.
As per regulation 18C of the Agvet Code Regulations, a label must be attached to the container for the veterinary 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 packaging for display purposes or shipping in which other containers of chemical products are, or are to be, placed for the purpose of being transported. The package (bag, carton, bottle etc.) in which a veterinary chemical product is packed and sold is the product’s container. These details are contained in regulation 18.
In cases where the size of a product container precludes placement of all the necessary information on a single panel, the label can be divided into 2 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 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 (e.g. carton), or the immediate container if there is no outer packaging
- the immediate container – the container that is in physical contact with the product (e.g. bottle, blister pack, syringe or bladder)
- a leaflet or booklet supplied with each single sale unit (where appropriate).
If there is no outer pack (e.g. carton), the immediate container is the primary pack. All information required on a label should be on the primary pack, if possible. 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) contain the remainder of the 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 must be included with the container.
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.
For more information, refer to the veterinary product label presentation and layout requirements.
The APVMA must have regard to certain matters or details in order to be satisfied that a label meets the labelling criteria to approve the label (sections 5D and 14 of the Agvet Code). Applicants must use the E-label template to submit the proposed label details that the APVMA must take into account.
E-label template and approved label
The APVMA will consider the details submitted via the e-label template (that is, the proposed label wording) to ensure the label meets the requirements set out in the Agvet Code and the Agvet Code Regulations.
The information required in the e-label template includes the following key legislative requirements:
- Relevant particulars (section 3, section 21(c)(i)-(iva) of Agvet Code)
- Distinguishing number (section 21(b) of Agvet Code)
- Name of holder (regulation 17(3)(a) of the Agvet Code Regulations)
- Adequate instructions for use (section 5D(1) of the Agvet Code, regulation 8AE of the Agvet Code Regulations)
- Label particulars prescribed by the regulations (regulation 17(1) of the Agvet Code Regulations)
- Label particulars determined by the APVMA CEO (regulation 17(2) of the Agvet Code Regulations)
- Conditions (subdivision 2.1.6 of the of the Agvet Code Regulations)
- Including regulation 18E: Label must comply with the requirements of the VLC
Note the VLC includes reference to legislative requirements and guidance on how to comply with the relevant particulars. For more information, refer to the label content requirements of veterinary chemical products.
If the proposed e-label wording submitted complies with the relevant particulars and conditions of label approval, the APVMA will approve this wording. The final e-label version is defined as the 'approved (product) label'.
Approval holders are required to incorporate the approved label wording (i.e. e-label) in the labels placed on containers for chemical products for supply to the market. These labels may include other information provided that is not contrary to the approved label wording. Other label content (e.g. transport, other legislative requirements not administered by the APVMA) does not need to be assessed or approved by the APVMA and is not covered by the e-label template. However, they must comply with the layout, presentation and legibility requirements of the VLC. This final version of the product label is the 'marketed product label' (MPL).
In addition, the MPL must comply with all statutory conditions of label approval as described in the Agvet Code Regulations; these are as follows:
- The label must be attached to the container for the chemical product to which it relates before the supply of the product (regulation 18C).
- The label must contain the distinguishing number, the instructions and particulars recorded in the relevant APVMA file (i.e. the approved label content) (regulation 18D(1)(a)).
- 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 (regulation 18D(1)(b)-(e)).
- The label must not contain information that is contrary to any of the above, including the relevant particulars (regulation 18D(2)).
- The information required on the label must not be altered, defaced, obliterated, obscured or destroyed (regulation 18D(3)).
- The label must comply with the APVMA’s labelling standard or if there is no standard, the VLC, whichever is in force at the time (regulation 18E).
- The label must not contain misleading or deceptive information (Regulations 18F).
There are conditions prescribed by the Agvet Code Regulations that apply to the holder of the label approval; these are as follows:
- The holder of the label approval must not make any claims about the product that is inconsistent with an instruction on the label (regulation 18G (1)).
- 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 5 years after the last supply of the product with that label (regulation 18H).
- The holder of a label approval must provide copies of the forms of labels and associated records to the APVMA on request (regulation 18I).
- 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 (regulation 18J)
Variations to approved labels
Changes to the information covered by the approved label (i.e. e-label 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 VLC and the other requirements of the Agvet Code and the Agvet Code Regulations.