Before reading these requirements, please refer to the label presentation and layout section for more information.

Although the APVMA no longer approves the final form of the label when finalising a registration or variation application, the Agvet Code provides that the APVMA may subsequently request the registration holder to provide us with a copy of the marketed product label. The registration holder is responsible for conversion of the approved relevant particulars into the marketed product label.

The information below provides guidance on the placement of information on labels and any layout requirements and details of label printing and colour requirements to ensure labels are legible. This information is relevant to both non-prescription and prescription products. Any differences are highlighted as required.

The size and type of container determines the space available for labelling and, therefore, the format or layout of a label and the space available for each item on the label. More space and a larger typeface should be allocated for key information.

Space must be allowed for items such as barcodes and hazard symbols and care taken to ensure that the:

  • legislative requirements for relevant poisons are not contravened
  • information of greatest importance to the user of the product is not difficult to read.

Important definitions related to packaging and labels are provided in Table 2.1. 

Table 2.1: Label presentation and layout definitions

Definition

Description

Related term

Immediate container

The container that is in direct contact with a packaged agvet chemical product

 

Label

From section 3 of the Agvet Code: Includes tag, leaflet, brand, stamp, mark, stencil or written statement.

label advisory statement, labelling, labelling code, approved label

Label advisory statement

The statement used to clarify the circumstances under which product use may be ineffective or hazardous due to extraneous factors not otherwise specified (described) on the label. General advisory statements also endeavour to provide important information related to controlled use.

label

Packaging

The container, together with the protective wrapping used to carry the chemical products via retail distribution to users.

All operations, including filling or labelling, that a bulk product has to undergo in order to become a finished product.

packaging group, packaging materials, secondary packaging

Primary pack

The pack in which a product and its inner pack are presented for sale. Where the immediate container is placed in an outer pack, e.g. carton, which is not just packaging for the sole purpose of display or shipping, this outer pack will be the primary pack. Where the immediate container is itself the outermost packaging presented for sale or supply, it will also be the primary pack

 

Secondary packaging

The process of placing filled, sealed and labelled primary containers into an outer, 'secondary' container.

packaging

2.1. Primary pack – main panel

Table 2.2 shows the type of information that must be shown on a primary pack. The relevant particulars must be shown on the main panel of the primary pack label in the following order and be visible at all times without the need to open packaging or leaflets.

Table 2.2: Information that must appear on the main panel of a primary pack

Required information

Order of appearance on label

Signal headings

1

Product name

2

‘Active constituent’ statement (and, where applicable, ‘Also contains’ statement)

3

Statement of claims for use

 

(Not mandatory for prescription products1 )

4 (at least in summary form)

‘Net contents’ statement 

 

(Prescription products2)

5

1 The statement of the registered claims for use of a product on the main panel of the primary pack label is not mandatory, although, the class or level of permitted prescribing should be stated. The class or level of permitted prescribing is determined by the APVMA during assessment of the product (see 'Statement of claims'). In addition, for parasiticides and antibiotics, the class or group (by mode of action) of the active constituents should be identified.

2 If the product is a prescription veterinary product that consists of discrete dosage units or has an immediate container that is not the primary pack, it is not normally required to mention that the container or units must not be sold separately in the ‘Net contents’ statement.

2.2. Primary pack – ancillary panels

Table 2.3 shows the type of information that must be shown on the ancillary panels of a primary pack. All claims and instructions for use, including any restrictions or limitations, must be visible at all times without the need to open the packaging or read leaflets or inserts.

When there is no user information leaflet or insert included in, or attached to, the primary pack, the following particulars, when required, must appear on the ancillary panels of the primary pack label, in the order shown in Table 2.3 (column 1).

If there is a user information leaflet or insert included in, or attached to, the primary pack, and where space is limited, the particulars appearing on the ancillary panels of the primary pack label may be reduced (see minimum required information column 2 in Table 2.3). When they are reduced, the following statement must be inserted above the ‘Directions for use’ heading:

Read the [enclosed/attached] leaflet/insert for full instructions

For prescription products, when it is permitted to dispense the product (determined during assessment, see ‘statements for claims for use’), the following statement must also appear immediately above the ‘Directions for use’ heading. See Table 2.3 (column 3) for minimum required information.

Use as directed by prescribing veterinarian.

Table 2.3: Information that must appear on the ancillary panel of a primary pack

Required information

Minimum required information (on reduced labels)

Minimum required information (on reduced labels) for prescription products

Order of appearance on label

Complete statement of claims for use (where summarised on the main panel)

Complete statement of claims for use (where summarised on the main panel)1

 Not required for dispensed products with a leaflet or insert.

1

The instructions for use section of a label, divided into the following subsections and expressed in this order:

  • Restraints
  • Contraindications
  • Precautions
  • Side effects/adverse reactions
  • Dosage and administration2
  • General directions
  • Withholding periods2
  • Trade advice2
  • Safety directions
  • First aid instructions
  • Additional user safety information (where appropriate)
  • ‘Environmental protection’ statement
  • ‘Disposal’ statement
  • ‘Storage’ statement

The instructions for use section of a label divided into the following subsections and expressed in this order:

  • Restraints
  • Contraindications
  • Dosage and administration2
  • Withholding periods2
  • Trade advice2
  • Safety directions
  • First aid instructions
  • ‘Environmental protection’ statement
  • ‘Disposal’ statement
  • ‘Storage’ statement

The instructions for use section of a label divided into the following subsections and expressed in this order:

 

  • Restraints
  • Dosage2
  • Withholding periods2
  • Trade advice2
  • Safety directions
  • First aid instructions

2

The following details must also appear below the items listed above unless they appear on the main panel away from the items required:

  • Name and address of the person primarily responsible for marketing the product
  • APVMA label approval number
  • Expiry date
  • Batch number

The following details must also appear below the items listed above unless they appear on the main panel away from the items required:

  • Name and address of the person primarily responsible for marketing the product
  • APVMA label approval number
  • Expiry date
  • Batch number

The following details must also appear below the items listed above unless they appear on the main panel away from the items required:

  • Name and address of the person primarily responsible for marketing the product
  • APVMA approval number
  • Expiry date
  • Batch number

 

3

1 Abbreviation for claim statements (for example primary packs of endo-and ecto-parasiticide products for small animals) where it appears in full on the leaflet or insert.

2 May be abbreviated where it appears in full on the leaflet or insert.

2.3. Immediate container

The immediate container is the container that is in direct contact with the veterinary chemical product.

  • When the immediate container is the primary pack – it must carry the same information in the same layout and format as required on the main and ancillary panels of the primary pack label (see Tables 2.2 and 2.3). If the container that is in direct contact with the product is a bag in a box, and the bag is firmly attached inside the box, and cannot easily be removed, it is considered as part of the box and does not require separate labelling. If; however, the bag is not stuck inside the box, it needs to be labelled as an immediate container, with the box as the primary pack.
  • When the immediate container is not the primary pack, it must carry the same information in the same layout and format as required on the main panels of the primary pack label (see Tables 2.2 and 2.3), but where space is limited, it may have reduced information on the ancillary panels (see Table 2.4 below). If further reduction of information is required where space is limited, the registrant must consult with the APVMA for approval, and this will be considered on a case-by-case basis.
  • When labels are reduced, either of the following statements, as appropriate, must be inserted above the ‘Directions for use’ heading:

Read the outer pack/carton for full instructions
Read the [enclosed/attached] leaflet/insert for full instructions

Table 2.4:Minimum information that must appear on the ancillary panels of the immediate container label

Required information

 Prescription products

Order of appearance on label

Statement of claims for use1

Not required for dispensed products with a leaflet or insert

1

The instructions for use section of a label is divided into the following subsections and expressed in this order:

  • Restraints
  • Contraindications
  • Dosage and administration1
  • Withholding periods1
  • Trade advice1
  • Safety directions
  • First aid instructions1
  • ‘Environmental protection’ statement
  • ‘Storage’ statement

The instructions for use section of a label is divided into the following subsections and expressed in this order:

  • Restraints
  • Dosage1
  • Withholding periods1
  • Trade advice1
  • Safety directions
  • First aid instructions

2

The following details must also appear on the ancillary panels of the immediate container below the items listed above unless they appear on the main panel away from the items required:

  • Name and address of the person primarily responsible for marketing the product2
  • APVMA label approval number
  • Expiry date
  • Batch number
  • Name and address of the person primarily responsible for marketing the product2
  • APVMA label approval number
  • Expiry date
  • Batch number

3

1 These statements may be abbreviated where they appear in full on the leaflet or insert.

2 Only the name is required where the address appears in full on the leaflet or insert.

Products containing discrete dosage units or packed in very small immediate containers – for example, foils or blister packs containing tablets or capsules; or syringes, ampoules, vials or tubes containing 20 mL or 20 g or less – when packed inside a primary pack that has all the required instructions for primary packs above may have the instructions that appear on the immediate container label further reduced (see Table 2.5).

Table 2.5: Minimum reduced information for very small containers or discrete doses packed inside a primary pack

Required information

Order of appearance on label

FOR ANIMAL TREATMENT ONLY

 
  • Distinguishing words of product name1
  • ‘Active constituent’ statement (may be abbreviated where necessary, e.g. for vaccines)
  • Contents (not needed for foils and blisters)
  • Name of the person primarily responsible for marketing the product
  • Expiry date
  • Batch number

 

1 Where a distinguishing word is used for several products – for example, for different target animal species or different concentrations of an active constituent – each will need to be distinguished by identifying the species or concentration. This information should appear at least once on every strip of foil or blister pack enclosed within a primary pack, and more frequently on packs that are scored for sub-division.

2.4. Leaflet

When a leaflet or insert is included in or attached to, the primary pack, it must include all of the information in the same layout and format as required on the main and ancillary panels of the primary pack label that do not contain a leaflet or insert, except for the:

  • expiry date
  • batch number
  • net contents (if the information for all pack sizes is the same).

If the leaflet is used as a common leaflet with other similar products, all product names, active constituent names and concentrations or strengths, and all APVMA numbers need to appear on it. This requirement can be met with a table on the leaflet that contains all of this information.

Note: If it is required by the APVMA, or requested by the applicant and permitted by APVMA, that detailed clinical or pharmacological information be included on a label to help the prescribing veterinarian understand the type of drug or the trial work carried out during the registration process, this may appear on a separate professional leaflet or insert. Alternatively, this information can be added under general directions. This will avoid unnecessary clutter or confusion with the end-user instructions that the prescribing veterinarian may wish to give the animal owner or carer.

2.4.1. Zip-seal labels

All information as detailed in Tables 2.2 and 2.3 is required on a zip-seal label. A zip-seal label must remain attached to the container. Table 2.2 information must be visible when the zip-seal label is folded. If a zip-seal label is attached to an immediate container that is also the primary pack, it may require certain information to be repeated so the information as per Table 2.2 is visible when folded. The content of the zip-seal (folder parts) should follow minimum requirements as per Table 2.3.