Labelling Codes – veterinary products

The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Code Regulations 1995 (Agvet Code Regulations) requires that all agricultural and veterinary chemical (agvet) products supplied to the marketplace must have a label attached to the container. In addition, the Australian Pesticides and Veterinary Medicines Authority (APVMA) cannot register an agvet product without also approving a label for containers for the product.

Among other things, a label must comply with the requirements of the Labelling Standard or, if there is no Labelling Standard, the Agricultural or Veterinary Labelling Codes made by the APVMA, as in force from time to time.

Label submission and approval

While all label information must comply with the relevant Labelling Standard or Code, the APVMA will only assess and formally approve the subset of label-related information identified in the E-label template (that is, the information to which the APVMA must have regard to satisfy itself that a label meets the labelling criteria and approve the label (sections 5D and 14 of the Agvet Code)). The final E-label version is defined as the ‘approved (product) label’.

Labels and label variations must be submitted electronically using the E-label template.

Please refer to the introduction to preparing a label and the label approval process for more information.

Veterinary Labelling Code

The Veterinary Labelling Code (VLC) draws together the requirements of the Agvet Code and the Agvet Code Regulations (including in relation to the relevant particulars of labels and label conditions). It also includes additional guidance developed by the APVMA to ensure labels for containers for veterinary chemical products reflect current best practice.

The VLC aims to accurately reflect legislative requirements. Labels for containers for veterinary chemical products must comply with the VLC. If the VLC is found to be inconsistent with the Agvet Code or the Agvet Code Regulations, the Agvet Code and the Agvet Code Regulations take precedence. The VLC may be revised from time to time.

Terminology

Where the term 'must' is used in the VLC, it is a legal requirement that labels comply with this provision or as determined by the APVMA.

Where the term ‘should’ is used in the VLC, the APVMA expects to see the statement(s) based on best practice and risk assessment or industry agreement.

Where the terms ‘may’ or ‘could’ are used in the VLC, it is strongly advised that this information is placed on labels, but is not compulsory. 

Any variation from these words must be justified by supporting information or argument.

Any specific wording required to be included on a particular product label will be determined by the APVMA during evaluation of the application for approval of the label or variation of the approved label.

Labelling requirements and guidance

The VLC is presented below as a series of labelling requirements that cover the label content, presentation and layout of the approved and marketed labels.

Label content – veterinary products explains the general labelling information that needs to be placed on labels for veterinary chemical products and provides examples of acceptable wording for certain statements where specific statements are not mandated by the legislation. Some variations to the general labelling requirements apply to certain product classes. The specific requirements relate only to the particular product types or certain aspects of labelling identified. The content of a specific labelling requirement may extend content, or replace part of the content, contained in the general labelling requirements. All labels should otherwise comply with the general labelling requirements.

Label presentation and layout – veterinary products explains the requirements and additional guidance on how approved and marketed labels are to be structured and presented.

Additional guidance on veterinary products and/or labelling that do not form part of the VLC are presented in the left-hand navigation menu for informational purposes only.

How to use the VLC

Specific labelling requirements for individual veterinary chemical product classes can be viewed by using the dropdown menu below. Alternatively, you can view both the general and specific labelling requirements for individual product classes on the label content section of the VLC.

Headings, mandatory statements or examples of specific wording are presented in grey boxes throughout the specific labelling requirements. These statements are displayed in the font and/or formatting required for the marketed label presentation (e.g. regular or bold typeface and lower or upper case). If font and/or formatting requirements are not stated, it is encouraged the statements follow the VLC example formatting.

Label presentation boxes

Additional information about the presentation of the marketed label and layout of specific sections can be accessed by clicking the ‘Click to view label presentation’ options throughout each part of the general and specific labelling requirements. This information will be displayed in a grey box and can be collapsed by clicking the ‘Click to view label presentation’ heading.

Please refer to the label presentation and layout of veterinary chemical products for more information on the format and presentation of marketed labels.

General labelling requirements

Specific labelling requirements

In addition to the standard labelling requirements, labels on ectoparasiticide products for sheep and goats should carry the following information, as applicable. Note that specific labelling requirements are provided for the following product types:

  • Off-shears backline products for lice
  • Short-wool products – plunge and shower dips (stripping and non-stripping dips)
  • Long-wool products – jetting and spray-on products
  • Flystrike control products
  • Itch mite products

You should refer to the statements required on labels for each product type as they appear for the relevant label sections. You may apply to us with a request to include alternative statements to those described below. You will need to submit data supporting your request. We will assess the data and if we agree we may approve the requested alternative label content. If the use of certain products is prohibited in certain states and territories, this should be indicated in this section.

Label presentation and layout examples are provided for some of the product types below:

Click to view example for off-shears backline products for lice

Example 1: Suggested ancillary panel layout for an off-shears pour-on lousicide product

EXPANDED CLAIMS: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel]
For the [eradication/control] of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep off-shears.

DIRECTIONS FOR USE:
Restraints:
DO NOT USE more than 24 hours after shearing.
Dosage and administration:
Use only on sheep that have been cleanly shorn.
Avoid treating ewes less than [x] weeks before lambing commences, while ewes are lambing or have lambs at foot, as live lice can persist and infect the lambs.
Treated sheep should not be mixed with untreated sheep until [x] weeks after treatment.
Dose rate: [x] mL per [y] kg body weight.

Animal

Pest

Body weight (kg)

Dose (mL of product)

Sheep

 

[x] kg

[y] mL

Apply as a single band from poll of the head to the base of tail as in diagram below. Sheep should be weighed before treatment. Treat sheep according to the heaviest animal by live weight in each group (ewes, rams, lambs). Do not underdose. Sheep in excess of 75 kg body weight to be dosed at x mL per y kg body weight.
[Appropriate pictogram]
General directions:
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

Click to view example for short-wool products – plunge and shower dips

Example 2: Suggested ancillary panel layout for a sheep dip for lice that strips out

Expanded claims:  [if abbreviated on main panel] [include scientific names of pests if not included on the main panel].
For the [eradication/control] of [chemical name]-susceptible strains of lice on sheep with short wool.
DIRECTIONS FOR USE:
Restraints:
DO NOT dip sheep more than 6 weeks after shearing.

Contraindications:
Dipping within 2 weeks of shearing is not recommended.

Dosage and administration:
Dipping sheep heavily infested with grass seed is not recommended.
For effective control of lice, thorough wetting to skin level is essential.
This is a stripping dip. Reinforcement with undiluted concentrate is required before topping up. When dipping out, reinforce only.

Animal (pest)

Treatment method

Initial charge

Reinforcement (always reinforce before topping up)

Topping up (when dip/sump level falls by approximately 25%)

Sheep (lice)

Plunge dip

[x] mL per 100 L water

Do not add water. Add [y] mL of product each time the level of dip wash falls by 500 L

Reinforce first. Then add [z] mL of product per 100 L of fresh water required

 Immerse heads of sheep at least twice after they enter the dip

Sheep (lice)

Standard shower dip

[x] mL per 100 L water

Add [y] mL of product each time the level of dip wash falls by 200 L

Reinforce first. Then add [z] mL of product per 100 L of fresh water required

 Do not use a shower dip with a sump volume less than 2,000 litres and do not allow dip level in sump to fall below half full

Sheep (lice)

Continuous replenishment shower dip

[x] mL per 100 L water

Not required

Use dip wash from the replenishment tank mixed at [y] mL per 1,000 L of water

 Maintain sump level at least 500 mm above pump intake

General directions:
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

Click to view example for long-wool products – jetting and spray-on products

Example 3: Suggested ancillary panel layout for a long-wool spray-on product for lice

EXPANDED CLAIMS: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel]
For the control of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with long wool.
DIRECTIONS FOR USE:
Dosage and administration:
For use on sheep more than 6 weeks after shearing.
Reduced effectiveness is likely if used on sheep with lumpy wool.
After the next shearing, sheep should be treated with an effective off-shears or short-wool product.
[Appropriate pictogram]

Animal (pest)

Treatment method

Months after shearing

Dose (mL of product)

Critical comments

Sheep (lice)

 

[x] months

[y] mL

Application instructions

[This example table shows the headings: Animal (pest); Treatment method; Months after shearing; Dose (mL of product). The first row contains the example for sheep.]

General directions:
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

Click to view example for all flystrike control products (including wound dressings)

Example 4: Suggested ancillary panel layout for a product that is used as a long wool jetting product for flystrike prevention and individual animal treatment of flystrike

Expanded claims: [if abbreviated on main panel] [include scientific names of pests if not included on the main panel]
For the protection for up to [x] weeks of strike by [chemical name]-susceptible strains of blowfly (Lucilia cuprina) when applied by jetting.
DIRECTIONS FOR USE:
Dosage and administration:
For use on sheep more than 6 weeks after shearing.
Reduced effectiveness is likely if used on sheep with lumpy wool.
Jet at onset of blowfly wave.
When used on sheep with less than 6 weeks wool a reduced period of protection may result.
This product is not recommended for use in jetting races because reduced efficacy and/or a reduced period of protection may result.
Do not collect and re-use fluid that runs off.

Animal (pest)

Treatment

Rate

Sheep (blowfly)

Jetting for prevention of flystrike

Add [y] mL product for each 100 L of water

[The example table above shows the headings: Animal (pest); Treatment; Rate. The first row contains an example for sheep.]

Animal (pest)

Treatment

Rate

Sheep (blowfly)

Dressing for treatment

Use [z] mL product for each 1 L water

[Th example table above shows the headings: Animal (pest); Treatment; Rate. The first row contains an example for sheep.]

Saturate struck area thoroughly.
General directions:
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER THE APPROPRIATE LEGISLATION.

2. Product name

2.1. Off-shears backline products for lice

Descriptive terms relevant to the type of product such as ‘pour-on’ or ‘spray-on’ should be used in the name.

3. Constituent statements

3.1. Active constituent statement

Bacteriostats approved by the APVMA should be included as an active constituent on the label when included in the marketed product.

4. Statements of claims for use

Claims must refer to susceptible strains of parasites. Both the common and scientific names of parasites must appear in the ‘Claims for use’ statement on the label. The scientific name must be written in italics or underlined.

Examples of ‘Claims for use’ statements include:

For the [eradication/control] of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep off-shears

For the [eradication/control] of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with short wool

For the control of [chemical name]-susceptible strains of lice (Bovicola ovis) on sheep with long wool

For [the treatment of/protection for up to x weeks against] strike by [chemical name]-susceptible strains of blowflies (Lucilia cuprina) when applied by dipping or jetting

Resistance may develop to any chemical

Any claims for efficacy against resistant strains of ectoparasites must be supported by efficacy data.

The abbreviated (main panel) claim should indicate the length of wool on which a product is to be used, such as ‘off-shears’, ‘short wool’ or ‘long wool’. These terms should be explained when used on the label. Variations to the definitions and time periods may be allowed in some circumstances when supported by data. Where these terms are not incorporated into the product name, they should be included in the product claim. Definitions are available on our website.

Click to view marketed label information

The following statement should appear under the ‘Claims for use’ section, towards the bottom of the main panel of the primary pack label. The statement must be printed in bold-face and sans-serif capital letters. For print size and style requirements, refer to the Printing and legibility requirements.

READ DIRECTIONS FOR USE BEFORE OPENING OR USING THIS PRODUCT

4.1. Off-shears backline products for lice

Where descriptive terms such as ‘pour-on’ or ‘spray-on’ or ‘backline’ are not included in the product name they should be included in the statement of 'Claims for use'.

4.2. All flystrike control products (including wound dressings)

For all flystrike control products, the approved protection period must be specified in the label claim by using one of the following alternative statements:

When applied as directed this product will protect against fly strike for [x] to [y] weeks

When applied as directed this product will protect against fly strike for up to [x] weeks

4.3. All itch mite products

Only claims for ‘control’ of itch mite will be permitted on a label unless a different claim can be demonstrated.

6.1. Restraints

6.1.1. Off-shears backline products for lice

Where applicable, the following statement should be included under the ‘Restraints’ heading:

DO NOT USE more than 24 hours after shearing

6.1.2. Short-wool products – plunge and shower dips

The following ‘Restraints’ statement is required:

DO NOT dip sheep more than 6 weeks after shearing.

6.2. Contraindications

6.2.1. Short-wool products – plunge and shower dips

The following ‘Contraindications’ statement is required:

Dipping within 2 weeks of shearing is not recommended

6.5. Dosage and administration

Where a premixing instruction is included, it should appear under the ‘Dosage and administration’ heading.

Dilution rates should be shown as:

[x] mL or litres [product]/100 litres water

Ratios or percentages should not be used.

Where appropriate, the dosage and administration instructions may appear in tabular form.

For products registered and approved for use on goats and sheep, the directions must include clear instructions for each species.

'Directions for use' should include a dose, volume or usage table (as outlined in the examples provided above in the introduction section).

6.5.1. Off-shears backline products for lice

All off-shears backline treatments should show the following statements:

Use only on sheep that have been cleanly shorn

Avoid treating ewes less than [x] weeks before lambing commences, while ewes are lambing or have lambs at foot, as live lice can persist and infect the lambs.
Treated sheep should not be mixed with untreated sheep until [x] weeks after treatment.

Dose information should include the following statements:

Dose rates are to be based on the heaviest sheep (goats) in the mob

Sheep (goats) must be weighed and where necessary, treated in separate groups based on body weight

Dose or volume tables with appropriate weight steps extending up to at least 75 kg must be shown to ensure minimum rates of application are reached. You must justify these rate steps in your registration application to the APVMA. All off-shears backline treatments should show the following headings in a dose or volume table:

Animal

Pest

Body weight (kg)

Dose (mL of product)

 

 

 

 

[This example table shows the headings: Animal, Pest, Body weight (kg), Dose (mL of product)]

A pictogram or photograph of a sheep illustrating the correct application method should appear on the label. For pour-on products, the correct method of application is generally from the poll of the head to the base of the tail. For other products (spray-on, etc.), the correct method should be clearly described.

The following statement should appear after the dose and volume table for sheep and goat products:

Apply as a single band from poll of the head to the base of tail as in diagram below. Sheep (goats) should be weighed before treatment. Treat sheep (goats) according to the heaviest animal by live weight in each group (ewes, wethers, rams, lambs); (bucks, does, kids). Do not underdose. Sheep (goats) in excess of 75 kg body weight to be dosed at x mL per y kg body weight.
[Appropriate pictogram]

Instructions should be added as appropriate for a product, including information relating to the applicator, method of application or clean-up after use.

6.5.2. Short-wool products – plunge and shower dips

Constant replenishment recommendations are only to apply to shower dips under 'Dosage and administration' unless data are provided to support use in plunge dips.

The following statements are required:

Dipping sheep heavily infested with grass seed is not recommended

Where applicable, use the following statements:

For effective control of lice, thorough wetting to skin level is essential.
Dip sheep at onset of fly wave. Thoroughly saturate sheep.

6.5.2.1. Stripping dips

The active constituent in stripping dips strips out of the wash through absorption by the wool. The complex dip management regimen must be clearly explained in the ‘Dosage and administration’ on product labels. A label statement should clearly indicate that the product is a stripping dip.

'Directions for use' must clearly show how falling sump volume requires first reinforcement and then topping up. Directions are required for both the addition of product (reinforcement) and combined product and water (topping-up) needed to maintain the dip at an effective level and strength. Both directions should be concise and clear enough to stand alone. Separate directions for ‘dipping out’ should not be used, because dipping out is covered by reinforcement. Reinforcement alone should only be used in cases where the addition of water is unwarranted or unwanted, either because the reduction in wash volume is too little to justify re-filling the dip or because dipping is nearly complete – that is, dipping out.

All stripping dips should show the following statement:

This is a STRIPPING dip. Reinforcement with undiluted concentrate is required before topping up. When dipping out, reinforce only.

Advice on exactly how to mix products into dips should be included. For some products, specific instructions are essential, such as the pre-mixing of powder products or some liquids. All such statements should be justified to the APVMA.

All stripping dips should show the following headings in a dose, volume or usage table:

Animal (pest)

Treatment method

Initial charge

Reinforcement (always reinforce before topping up)

Topping up (when dip or sump falls by approximately 25%)

 

 

 

 

 

[This example table shows the headings: Animal (pest); Treatment method; Initial charge; Reinforcement (always reinforce before topping up); Topping up (when dip or sump falls by approximately 25%)]

6.5.2.2. Non-stripping dips

The active constituent in non-stripping dips does not strip out of the wash through absorption by the wool. The dip management regimen must be clearly explained in the 'Directions for use' on product labels. A label statement should clearly indicate that the product is a non-stripping dip.

'Directions for use' must clearly show how falling sump volume requires topping up. Directions are required for the addition of combined product and water (topping-up) needed to maintain the dip at an effective level.

All non-stripping dips should show the following statement:

This is a NON-STRIPPING dip. Reinforcement with undiluted concentrate is not required when topping up. When dipping out (when the level of dip wash falls by more than 25%) add [...] mL of product per 100 L of water each time the level of dip wash falls by 500 L (or 200 L for shower dips).

You should include advice on exactly how to mix products into dips. For some products, specific instructions are essential, such as the pre-mixing of powder products or some liquids. All such statements should be justified to the APVMA.

All non-stripping dips should show the following headings in a dose, volume or usage table:

Animal (pest)

Treatment method

Initial charge

Topping up (when dip/sump level falls by approximately 25%)

 

 

 

 

[This example table shows the headings: Animal (pest); Treatment method; Initial charge; Topping up (when dip/sump level falls by approximately 25%)]

6.5.3. Long-wool products – jetting and spray-on products

Long-wool products are for use on sheep more than 6 weeks after shearing. In addition to the general labelling requirements for sheep and goat ectoparasiticides, the labels on long-wool products should also comply with the following requirements, as relevant.

The following statements should appear on all long-wool products unless modified, subject to APVMA approval based on appropriate data.

For use on sheep more than 6 weeks after shearing.
Reduced effectiveness is likely if used on sheep with lumpy wool.

The following statement should appear on products that have not been registered with a claim for eradication of lice but may be modified subject to APVMA approval based on appropriate data:

After the next shearing, sheep should be treated with an effective off-shears or short-wool product.

The following statement should appear on products registered for jetting of sheep for either fly or lice control but may be modified subject to APVMA approval based on appropriate data:

This product is not recommended for use in jetting races because reduced efficacy and/or a reduced period of protection may result.

Where dose rates depend on the length of wool or the time since last shearing (either or both may be used), including those for jetting products for flystrike prevention or long-wool lice control, then appropriate instructions should be shown with the following headings in a dose or volume table:

Animal (pest)

Treatment method

Months after shearing

Dose (mL of product)

 

Spray-on

 

 

 

Jetting

 

 

[This example table has 4 columns with the following headings: Animal (pest); Treatment method; Months after shearing; Dose (mL of product). Most of the remaining cells are empty, except for the ‘Treatment method’ column, which contains in the first row, ‘Spray-on’ and in the second row, ‘Jetting’]

In addition:

Where mixing directions are required, they should also be included in the table above.

Information relating to the applicator, method of application or clean-up after use should be included. Statements relating to pump pressure, method of jetting, etc. should also be included. Note: the APVMA may approve the use of jetting races if appropriate data are supplied and the trade name and/or type of the jetting race(s) is included on the label.

For spray-on products, a pictogram or photograph of a sheep illustrating the correct application method should appear on the label.

6.5.4. All flystrike control products (including wound dressings)

Products registered for flystrike control on sheep or goats should also include the following statements (as appropriate):

Jet at onset of blowfly wave.
When used on sheep with less than 6 weeks wool a reduced period of protection may result.
This product is not recommended for use in jetting races because a reduced period of protection may result.
DO NOT collect and re-use fluid that runs off.

Specific directions for use should be included in the dose or volume usage table. Where claims for pests other than blowfly are also made the directions in the table must clearly distinguish between each pest for which claims are made.

6.5.5. All itch mite products

Specific directions for use should be included in the dose or volume usage table. Where claims for pests other than itch mite are made, the directions in the table must clearly distinguish between each pest for which claims are made.

6.6. General directions

For all ectoparasiticides, the following statement must appear under the ‘General directions' heading:

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION

Click to view label presentation

The general limitation statement must be given in boldface, sans-serif capital letters. For print size and style requirements, refer to the Printing and legibility requirements.

For all products that are applied topically, advice on rainfastness (the time after an application when the product may need to be re-applied if heavy rain falls) must be included on labels in the 'General directions'. Data should normally be available from efficacy studies.

Other information that may be included in the 'General directions', as appropriate for a product, includes compatibility statements, instructions to avoid settling, instructions for mixing, topping up and dipping out dips, mycotic dermatitis information and bacteriostat requirements.

7. Withholding period statements

Appropriate withholding period statements for meat, milk and wool are to be included on labels. Meat and milk ‘Withholding period’ statements are to precede those for wool.

Note:

  • The wool ‘Withholding period’ statement is sometimes referred to as the wool harvesting interval. Recommended wool withholding periods for some active constituents can be found in the 1 July 2014 Gazette (page 15). Shorter withholding periods must be supported by data. For new actives, the withholding period will be determined during assessment.
  • For wound dressings and flystrike treatments for individual sheep, default withholding periods of at least one month apply, unless data is supplied to support a shorter withholding period.