General requirements: Hormonal growth promotants

1.1. Signal words

If the product contains a substance that is classified as a scheduled poison in the current Poisons Standard, the label must include any signal words relating to the schedule in which that substance is included.

There are 5 schedules relevant to veterinary medicines. Scheduling of veterinary medicines is a function of the Australian Department of Health and is governed by the Poisons Schedules.

• Schedule 4: PRESCRIPTION ANIMAL REMEDY
• Schedule 5: CAUTION
• Schedule 6: POISON
• Schedule 7: DANGEROUS POISON
• Schedule 8: CONTROLLED DRUG

For a Schedule 8 poison, the following cautionary statement is also required:

1.1.1. Other cautionary words or phrases

1.1.1.1. Keep out of reach of children

If the product contains a substance that is classified as a poison in the current Poisons Standard, the following statement must be included on the label as part of the signal heading:

For products that do not contain scheduled substances, this statement must not appear in the signal heading; however, you may incorporate it with the storage instructions.

1.1.1.2. Read safety directions before opening or using

Either of the following statements must be included whenever safety directions are required on the label as determined during product evaluation:

This requirement also applies to products that do not require any other signal heading (that is, they are not scheduled substances) but are required to include safety directions. If this statement is required for products that do not contain any scheduled substances, it must be the first line of the signal heading.

1.1.1.3. For animal treatment only

The following statement is required as part of the signal heading of all veterinary chemical products:

Although this statement must be included as part of the signal heading of all veterinary chemical products, it must not be used for products that are not medicinal or do not contain scheduled substances, such as food and food supplements, as these products are not regarded as being for treatment of animals.

1.1.1.4. Other cautionary words and statements

Other words and cautionary statements may be required in the signal headings, depending on the types of constituents in a particular product. These statements will be determined by us on a case-by-case basis during product evaluation and, if the application is granted, they will become part of the approved particulars for the product.

The label must include the name of the chemical product. This does not have to be the same as the distinguishing name recorded in the APVMA register for the chemical product. The following guidance is relevant to both the distinguishing product name and the chosen label name if this differs.

Please keep in mind the following advice when deciding on a product name:

• The product name must be distinctive. It must not be misleading (for example, if a claim has not been approved it must not be used in the product name), confusing or inconsistent with other label instructions or be easily confused with or similar to other registered product names. The APVMA will compare the name against APVMA registered products, but it is the applicant’s responsibility to ensure the proposed name is unique and does not infringe on any other products or trademark names.
• To reduce the incidents of misuse, the name of veterinary chemical products should describe:
  • the dosage form and route of administration (e.g. oral powder, feed additive, oily injection, inhalant, tablet, spray-on, dip, oral paste, dip and spray, pessary, injectable suspension, oral suspension, pour-on worm treatment)
  • the target animal(s)
  • where possible, its intended purpose (e.g. cattle lice and fly treatment, anthelmintic for sheep and lambs).

For example, a simple approach is to use a trade name, followed by dosage form, route of administration and, where possible, the intended purpose.

• We may approve the word ‘plus’ or its symbol ‘+’ in a name when another active constituent is added to a currently registered product to extend the medicinal claim. In this instance, the name of the new active constituent or class of constituent should be listed after the use of the word or symbol. Note we would not normally approve the word or symbol for ‘plus’ in a name in any other circumstances.
• We may approve the use of the symbol ‘&’ for the word ‘and’ in a name.
• A trademark symbol or registered trademark symbol do not form part of the approved label. If relevant, these can be included on the marketed label. 
• When numbers are used as part of the product name, they must relate to the level or concentration of the active constituent in the product and be expressed in metric units (not percentages).

For example:

Exceptions: The APVMA may permit the inclusion of references to dose rates in relation to weights of target animals in the product name (for example, TICKEX 20, where a unit of the product was the dose for a 20 kg dog or 5 IN 1 for multivalent vaccines).

3.1. ‘Active constituent’ statement

The label must contain the name and proportion of each active constituent in the product.

The active constituents are the substances that are primarily responsible for the biological activity or other effect identifying the product as a veterinary chemical product. This biological activity, or other effect, together with the proposed uses, makes the product a veterinary chemical product.

The concentration of the active constituent must be clearly stated in front of the name of the constituent.

Where 2 or more active constituents are present in the end-use product, the following conditions apply:

• The active constituents must be shown in descending order of concentration (highest to lowest).
• When solvents, synergists or other scheduled ingredients are present, even when present at higher levels than the active constituents, they must be shown after the main active constituents.

3.1.1. Name of constituents

The name for scheduled constituents must be the name specified in the current Poisons Standard.

If a poison schedule does not apply, the preferred name for constituents is:

• the name in the Therapeutic Goods Administration (TGA) approved terminology for medicines, which is the Australian approved name (AAN)
• the name, not including synonyms by which the constituent is described in; for example, the British pharmacopoeia, the British pharmaceutical codex, the Australian pharmaceutical formulary and handbook, or the British pharmacopoeia (veterinary), the European pharmacopoeia, or the United States pharmacopeia
• the name approved by Standards Australia
• the name given by the International Organization for Standardization
• the name given by the British Standards Institution
• the accepted scientific name (in the Chemical Abstracts or International Union of Pure and Applied Chemistry) or the name descriptive of the true nature and origin of the constituent.

3.1.2. Expression of quantities

The quantity for the constituents must be expressed in metric terms according to the formulation.

All units of mass or volume must be written in full or represented by their correct symbols, such as gram or g, litre or L. For example:

• gram/litre or g/L for large volume liquid preparations (1 litre or more)
• gram/kilogram or g/kg for large volume solid preparations such as premixes
• milligram/millilitre or mg/mL for injectable preparations and small volume liquids (less than 1 litre)
• milligram/gram or mg/g for small volume solid or semi-solid preparations
• gram/kilogram or g/kg for aerosol preparations
• µg should be used as the abbreviation of microgram.

Expressions for a product packed in discrete dosage units include:

International units, or potency units, may be applicable to some preparations, such as antibiotics, sera and biologicals, but only if preparations cannot be described as above.

Vitamins A and D must be expressed in International Units (IU) while other vitamins must be expressed in metric units.

The ‘Active constituent’ statement for direct-fed microbials should read:

This should then be followed by a listing of each of the microorganisms and their quantitative particulars, such as colony-forming units per gram (CFU/g).

Salts or esters of active constituents that are used in a formulation must indicate the amount of active moiety present and nominate the salt or ester present, for example:

3.1.3. Format for constituents that contain vitamin and mineral preparations

Vitamin and mineral preparations should have the ingredients listed in the following order:

• Fat-soluble vitamins
• Water-soluble vitamins
• Minerals
• Antioxidants
• Other ingredients

3.2. Synergists

The label must contain the name and proportion of any constituent that has synergistic activity in the product.

Synergists are constituents that on their own may not be known to be biologically active for the particular use described, but their inclusion may result in a synergistic effect with the active constituents so the product may not be as effective without them (for example, piperonyl butoxide as a synergist for pyrethrin).

The concentration and name of any synergistic constituents must:

• be preceded by the subheading:

• be placed immediately below the ‘Active constituent’ statement and parallel to other printed matter on the label
• have immediately following or beside the ingredient statement the word:

3.3. Other scheduled constituents

The label must:

• contain the name and proportion of any solvent or any other constituent in the product that is a scheduled medicine or poison in the current Poisons Standard. These must be placed immediately below the ‘Active constituent’ statement and parallel to other printed matter on the label and be preceded by the subheading:

• If the constituent is a solvent, it must have immediately following or beside the constituent statement, the word:

Appropriate use of ‘Also contains:’ statements is determined by the APVMA on a case-by-case basis.

3.4. Other ingredients

The subheading ‘Also contains:’ is not considered appropriate for unscheduled non-active constituents or food constituents to supplement diets where levels may be low – such as vitamins, minerals or amino acids fed at normal dietary levels. These ingredients may be included under the following subheading on the ancillary panel:

3.5. Hormonal growth promotants

3.5.1. 'Active constituent' statement

The following statements must appear under the ‘Active constituents’ heading:

The label must include a statement of the claims (indications) for use that have been approved for the product. The claims for effective use of a product are determined by the APVMA on a case-by-case basis during product evaluation.

Please keep in mind the following advice when creating a ‘Claims for use’ statement.

• For parasiticide and antibiotic products, the class or group (by mode of action) of the active constituents should be identified. 
• For prescription-only products, the class or level of permitted prescribing should be stated as follows:
  • When the level of permitted prescribing is either for use by, or under the supervision of a registered veterinarian, either of the following statements should appear as the first (and possibly only) statement of claims on the main panel of the label:

    For use only by a veterinarian

    For use only by or under supervision of a veterinarian

  • When it is permitted to dispense the product, the following statement should appear as the first statement of claims on the main panel of the label:

    For use by or under direction of a veterinarian

  • This statement should also appear immediately above the ‘Directions for use’ heading (see '6. Directions for use' below) on the ancillary label panel:

    Use as directed by prescribing veterinarian

  • The use of these statements will be determined during product evaluation.
  • Note: the above disclaimer statements may also be required for non-prescription veterinary products, where the product evaluation has identified a risk related to the approved use.

• All labels should have accurate and moderately worded claim(s). The claim(s) must not imply excessive efficacy or make a comparison with other competing products.
• The name(s) of the intended target species (for example, dog, cat, horse, sheep) should be included in the statement of claims on the main panel.
• The disease, condition or other pharmacological or physiological effect in each target animal species, and (where applicable) in each class of animal must be clearly stated. Claims must be directly related to the parameters measured in the pivotal target animal efficacy trials you submitted for registration.
• The Linnaean binomial (scientific name, bracketed and in italics or underlined) and common name used in Australia of each pest, parasite or disease organism for which an effect is claimed should be included in the ‘Claims for use’ statement. The Linnaean binomial is optional in the abbreviated claim if included in the extended claim on the ancillary panel or on the leaflet (where space is limited).
• Labels of parasiticides (except ectoparasiticides for dogs and cats) and antimicrobials must also include a resistance warning statement.
• Important restrictions, limitations, contraindications or warning statements that affect the use of the product can also be repeated in the ‘Statement of claims’ on the main panel.

The label must state the net contents of the product.

Please keep in mind the following advice when creating a ‘Net contents’ statement.

• The heading ‘Contents’ is optional.
• In accordance with the requirements of the National Measurement Act 1960 and its regulations, units of mass or volume must be metric and written in full or represented by their correct symbols:
  • Liquids must be expressed by reference to volume, usually as:

• Solids, semi-solids or pastes must be expressed by reference to mass, usually as:

• Products containing discrete dosage units, like tablets or syringes, must be shown as the number of units – for example:

• Aerosol cans must be expressed as:

• For a non-prescription veterinary product that consists of discrete dosage units or where an immediate container is not the primary pack, it is illegal to sell these units/containers individually. Products must be sold as originally packaged with full labelling, which may include a leaflet or insert. The ‘Net contents’ statement must contain either of the following words on the primary packaging:

• It is optional to add the number of doses per pack for vaccines.

6. Hormonal growth promotants

The following statement must appear immediately under the ‘Directions for use’ heading:

The label must include adequate directions for use of the product and be arranged under the relevant sections:

• Restraints
• Contraindications
• Precautions
• Side effects/adverse reactions
• Dosage and administration
• General directions

Directions for the safe and effective use of a product are determined by the APVMA on a case-by-case basis during product evaluation.

‘Directions for use’ is the main heading and does not include any information between it and the first subheading, with the exception of the general limitation statement for hormonal growth promotants. Please refer to the specific labelling requirements for this class of product.

A restraint is an absolute limitation or restriction placed on the use of the product. The limitation is required to manage a risk associated with the use of the product, which may be necessary with regard to human safety, public health or environmental protection. These include issues related to residues, antibiotic resistance or specific treatment periods that have been determined during product evaluation. ‘Restraint’ statements must also be included where a withholding period has not been established for an animal producing a specified commodity. Efficacy or animal safety restraints may be required if not covered separately under Precautions, Contraindications or Side effects.

Each separate ‘Restraints’ statement must commence on a new line.

‘Restraints’ statements must begin with text such as:

NOT TO BE USED

USE ONLY

6.1.1. Statements required for an animal producing a specified commodity where a withholding period has not been established

A ‘Restraints’ statement is used when a withholding period cannot be set for an animal producing a specified commodity. This means the product has a limited or restricted use in animals that are producing a specified commodity.

When the chemical or product is not intended for use in any food or fibre-producing species of animals, and there is a risk associated with human safety, public health or environmental protection if the product were to be used (i.e. substances not approved for use in food-producing species of animals), the following statement must be used:

6.1.1.1. Meat

Where a withholding period is not established for a product for use in an animal used for human consumption (i.e. cattle, sheep, goats, pigs, rabbits), the following statement should be used:

6.1.1.1.1. Statements required for horses

Although horses are not currently defined as a food-producing animal, a restraint statement should be used for horse products where a withholding period has not been established.

For products containing:

• synthetic pyrethroids, aminoglycoside antibiotics or non-steroidal anti-inflammatory drugs (unless residue data are available to support a withholding period)
• substances having a thyrostatic, oestrogenic, androgenic, gestagenic, somatotrophic or beta-agonistic action
• substances that are not approved for use in food-producing animals (unless residue data are available to support a withholding period),

the following ‘Restraints’ statement is required:

6.1.1.1.2. Ornamental fish only products

Where a product is for use in ornamental fish only, but the product could be used in fish for human consumption (e.g. antibiotics) and there are risks associated with residues, the following statement should be used:

6.1.1.2. Milk

All products for use in, or on animals from which milk may be used or processed for human consumption, where a withholding period is not established, should have one of the following statements depending on residue data available:

DO NOT USE [in/on] lactating or pregnant [animal species] where milk may be used or processed for human consumption

DO NOT USE [in/on] lactating [animal species] or within [x] days of [calving/lambing/kidding] where milk may be used or processed for human consumption

DO NOT USE [in/on] lactating [animal species] where milk may be used or processed for human consumption

6.1.1.3. Eggs

All products for use in, or on birds from which eggs may be used or processed for human consumption, where a withholding period is not established, should have one of the following statements depending on residue data available:

DO NOT USE [in/on] birds during lay where eggs may be used or processed for human consumption

DO NOT USE [in/on] birds during laying or within [x] days of laying where eggs may be used or processed for human consumption. If laying takes place within [x] days, those eggs must not be used or processed for human consumption

6.1.1.4. Honey and other bee products

Where use in, or on bees or beehives is not permitted, you should use a statement such as the following:

Where available residues data indicate that residues preferentially partition into bee by-product fractions (for example, wax), the following ‘Restraints’ statement may be appropriate:

6.1.2. Re-treatment interval

A re-treatment interval must be included on products used in or on food-producing animals where a repeat dosage regimen can be reasonably expected, even if a repeat dosage regimen is not specified on the label. The re-treatment interval will be determined by the APVMA during evaluation of the product.

An example statement for the re-treatment interval is shown below:

6.1.3. Hormonal growth promotants

All products must carry the following statements under the ‘Restraints’ heading:

When use in heifers is approved, this additional statement is required:

Contraindications refer to situations that arise from a set of circumstances where the veterinary chemical product should not be used for target animal safety reasons.

Contraindications statements should indicate either one of the following statements when the product:

• should never be given
• is generally not indicated if there are safety issues for the target animal
• has evidence that toxicity will occur in a particular situation or physiological state or in an off-label animal species.

Please keep in mind the following advice when creating a ‘Contraindications’ statement:

• A ‘Contraindications’ statement must begin with text such as:

Not to be used in [species (or species with a particular/condition)]

Or

Not recommended in [species (or species with a particular/condition)]

Or

Not intended for use in [species (or species with a particular/condition)]

Or

Contraindicated for use in [species (or species with a particular/condition)]

• Where multiple statements are proposed in the contents of this subheading, there is no requirement to start each statement in the format mentioned above.

• ‘Contraindications’ statements are also relevant where test results or adverse experience reports for the product demonstrate an adverse effect.

• ‘Contraindications’ statements should be grouped according to the outcome, i.e. complications associated with the use of the veterinary medicine, and should explain the mechanism of action (where known).

For example: Contraindicated for use in animals suffering from cardiac, hepatic or clinical renal disease. This is also the case where there is the possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a haemorrhagic disorder or individual hypersensitivity to the product.

‘Precautions’ statements aim to minimise health risks to target animals from approved use(s) of a product.

They are normally used when there is insufficient evidence to demonstrate safety in a particular situation or physiological state. For example: ‘Precautions’ statements are relevant where test results for the product are not available for all physiological situations (for example, a pregnant or lactating female, a foetus or neonate and/or an aged animal).

Please keep in mind the following advice when creating a ‘Precautions’ statement:

• A ‘Precautions’ statement must begin with text such as:

Use with caution

• Where multiple statements are proposed in the contents of this subheading, there is no requirement to start each statement in the format mentioned above.
• Statements regarding incompatibilities should also be included as precautions.
• ‘Precautions’ statements should be grouped according to outcome and explain the mechanism of action (where known).

For example: Use with caution in pregnant, lactating or breeding dogs as the use of this product has not been evaluated. However, the active ingredient is essential for normal foetal development. Therefore, regular monitoring of breeding bitches throughout pregnancy and lactation should be undertaken as dose requirements may be altered during this time.

6.3.1. Hormonal growth promotants

The following statements must appear under the ‘Precautions’ heading:

When the product contains trenbolone, the following alternative statement is required (3 months for grass-fed or 6 months for lot-fed beef):

Statements on side effects or adverse drug reactions alert the end users of effects that may occur in the target animal from approved use(s) of a product (such as anaphylaxis).

Statements must indicate the severity and clinical importance. Statements on the treatment of the effects should be indicated and these will be considered on a case-by-case basis.

You should also include statements on how to avoid, recognise and treat overdosage under this heading. These will also be considered on a case-by-case basis.

6.4.1. Hormonal growth promotants

The following statements must appear under the ‘Side effects’ heading:

A ‘Dosage and administration’ statement is always required on the label and should include instructions on:

• the specific dose rate (for example, [x] mg of active constituent/kg body weight of animal)
• the general dose rate or inclusion rate (for example, [x] mL of product/10 kg body weight or [y] kg of product/tonne of feed, depending on the formulation type/pharmaceutical dosage form) for each species
• the method and route of administration
• the frequency of dosing
• the duration of treatment
• any special instructions relating to dosage and administration.

Special instructions may include a veterinarian disclaimer statement, dosage adjustment in renal or liver disease or concomitant disease, maximum tolerated daily dose, maximum dose for an entire course of therapy, monitoring advice and other information (for example, relating to administration with food).

All units of mass or volume must be stated in metric units and, where abbreviated, must be represented by their correct scientific nomenclature.

The number of animals treated per pack is not required for the APVMA-approved label but may be included on the marketed label.

6.5.1. Mixing directions and in-use shelf life

• Relevant mixing directions should describe how the product must be prepared before use and administration.
• Parenteral and other sterile products in multi-dose containers (including sterile injectables, solutions and vaccines) must include an in-use shelf life statement on the label, which are determined by the APVMA during evaluation and are based on chemistry data.
• For sterile injectable products (excluding vaccines), the default in-use shelf life is 24 hours. If an alternative in-use shelf life is proposed, supporting data or argument must be submitted to the APVMA for evaluation.

For example:

• Where an in-use shelf life has not been previously determined for a (reconstituted) vaccine product, the following statement should be included:

6.5.2. Hormonal growth promotants

The following statements must appear in the ‘Dosage and administration’ section:

General directions include any other instructions or advice for the safe and effective use of the product not included elsewhere on the product label. Examples include statements on the general limitation for ectoparasiticides, antibiotic and anthelmintic resistance, non-prescription injectable product warnings, performance animal withholding periods and compatibility for mixing the product with other products.

Please keep in mind the following advice when creating a ‘General directions’ statement.

• A general limitation statement related to specific product types must be included in this section. This statement should appear as the last sentence in this section. For example, the general limitation statement for ectoparasiticides, antibiotics, etc. is:

• Products that may be used in performance animals (for example, racing horses) may carry the following statement:

• Compatibility statements require evaluation and approval before addition to the label.

6.6.1. Hormonal growth promotants

The following statements must appear under the ‘General Directions’ heading:

The withholding period is the minimum period that should elapse between the last administration or application of a veterinary chemical product (including treated feed) and the slaughter, collection or harvesting for human consumption or use of the animal commodity. It is required to avoid unacceptable residues of veterinary chemical products and/or their metabolites in animal commodities.

• Where there is more than one withholding period, each one should be preceded by an appropriate descriptor and appear on a separate line. For example:

• Where a product can be used in, or on more than one species and/or by more than one route of administration and the withholding periods are different, these differences should be clearly indicated on the label. For example:

• Where no time is required for a withholding period, the following statement should be shown on the label:

• When a withholding period cannot be established for an animal producing a specified commodity, a ‘Restraints’ statement must appear on the label. The ‘Restraints’ statement should appear under the 'Restraints' subheading in the 'Directions for use' section. It is not necessary to also include the restraint under the ‘Withholding periods’ heading.
• For prescription products, the prescribing veterinarian should be made aware that any variation to the registered use pattern (under veterinary prescribing rights) may require a different withholding period. If required, this must appear as the last statement under the ‘Withholding periods’ heading. For example:

7.1. Statements required for food-producing species

Depending on the species of animal, more than one commodity may be produced. For example, statements may be required for the meat alone, or for meat and/or milk or eggs. Table 1 lists species and their relevant commodities that may require statements.

Note: Meat also includes offal.

Minor species are also required to carry appropriate statements. Appropriate statements for each type of commodity are listed below.

7.1.1. Meat

All products for use in, or on meat-producing species of animals (for example, cattle, sheep, goats, poultry, pigs, aquatic species and rabbits) are required to carry an appropriate ‘Withholding period’ statement for meat, unless a restraint statement is included for that particular animal species.

The following ‘Withholding period’ statement examples should be used:

When harvesting aquatic species for slaughter, degree days should be used. For example, 500 degree days = 50 days at 10˚C water temperature or 25 days at 20˚C water temperature. The following ‘Withholding period’ statement should be used:

7.1.2. Milk

7.1.2.1. Non-intramammary products

All products for use in, or on animals from which milk may be used or processed for human consumption are required to carry an appropriate 'Withholding period' statement, unless a restraint statement is included for that particular animal species.

The following 'Withholding period' statement examples should be used:

7.1.2.1.1. Cows

7.1.2.1.2. Other milk producing species

7.1.2.2. Intramammary products

Products for use in lactating cows should use the following statement:

Products for use in dry cows should use the following statement:

7.1.3. Eggs

All products for use in, or on birds from which eggs may be used or processed for human consumption are required to carry an appropriate 'Withholding period' statement unless a restraint statement is included.

Producers cannot usually implement a withholding period other than a zero day withholding period. Where a zero day withholding period is established, the following statement applies:

If a withholding period can be established for eggs, the following example should be used:

7.1.4. Honey and other bee products

All products for use in, or on bees or beehives that produce honey or bee by-products (including comb honey, royal jelly and propolis) for human consumption or processing are required to carry an appropriate ‘Withholding period’ statement, unless a restraint statement is included. ‘Withholding period’ statements for honey are based on honey residues data generated with treated bees or beehives.

Where the use of products in, or on bees or beehives is permitted, you should use one of the following ‘Withholding period’ statements:

7.2. Statements required for fibre-producing species

The following ‘Wool Harvesting Interval’ statements are required for the wool of sheep and the fibre (for example, mohair) of goats, alpacas and llamas.

7.3. Statements required for horses

Although horses are not currently defined as a food-producing animal, horse products are required to carry a ‘Withholding period’ statement for meat, unless a restraint statement is included for horses.

The inclusion of this statement is particularly important for products not used in other meat-producing species. For products that are also used in species other than horses, the statement should begin with:

A ‘Withholding Period’ does not refer to a withdrawal period required by the relevant racing or performance authorities to ensure horses are presented for competition drug-free. This information should appear under the 'General directions' subheading under the ‘Directions for use’.

The options for this statement are:

• for products where there are no residue concerns, for example:
  • products where the residues are identical to or indistinguishable from natural food components, or are otherwise of no toxicological significance
  • most vaccines (unless otherwise directed by the APVMA)
  • many nutritional and general healthcare products – including most stockfoods, vitamins, mineral or amino acid supplements, electrolyte supplements, hoof and coat care products, grooming aids, rubefacients, liniments or poultices, skin emollients, antiseptics or astringents (provided they do not contain prescription drugs or unless otherwise directed by the APVMA) – a withholding period is not required and the following statement should be used:

WITHHOLDING PERIODS: Zero (0) days

• for other products that are registered for use in food-producing animals, a ‘Withholding period’ statement may be set on data or argument. If scientific data or argument is not presented to establish a withholding period then a conservative default period will be used with the following statement:

DO NOT USE less than [x] days before slaughter for human consumption

A default period of 28 days will be used where the withholding period for all the food-producing animals on the label is less than or equal to 7 days. A default period of 60 days will be used where the withholding period for all the food-producing animals on the label is between 7 and 28 days.

The label must include any export slaughter, collection or harvest interval statement or trade advice that is required to avoid unacceptable residues of veterinary medicines and their metabolites in animals or produce that may be exported, where those residues have the potential to unduly prejudice Australian trade.

All products for use in, or on cattle, sheep and pigs require 'Trade advice' statements. Products for use in, or on other food-producing species may also have 'Trade advice' statements assigned to them if it is considered necessary to manage potential risks to trade. 'Trade advice' statements for a product are determined by the APVMA during evaluation.

8.1. Trade advice statements for meat commodities

Where an export slaughter interval (ESI) has been established for the product:

Where an export slaughter interval (ESI) has been established for more than one animal species:

Where the same ESI has been established for more than one species:

Where the ESI is zero days:

Where an ESI has not been established for the product:

8.2. Trade advice statements for wool

Where an export wool harvest interval has been established for the product:

Where no harvest interval has been established for wool, the following statements may be used:

Under state and territory poisons and pesticides legislation, scheduled substances and their preparations, which may be harmful to the user, must be labelled with safety directions that specify human hazards, precautions and instructions related to safety in handling, mixing and using the product. Safety directions, warning statements and general safety precautions for agricultural and veterinary chemicals are given in the First Aid Instructions and Safety Directions (FAISD) Handbook published by the APVMA.

Safety directions are established for specific product formulations (rather than active constituents) during APVMA product evaluation and are entered into the FAISD Handbook. Not every registered veterinary product will necessarily have an entry in the FAISD Handbook.

Please keep in mind the following advice when creating a ‘Safety directions’ statement:

• Where safety directions are required, the appropriate signal heading (as determined by the APVMA, based on the Poisons Schedule) should also be included on the label.
• Safety directions may be required even if the active constituent is exempt from poisons scheduling.

9.1. Warning statements and general safety precautions

Warning statements and general safety precautions are substance-specific and generally apply to all formulations in which that substance is an ingredient, and in concentrations at which the substance is scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Warning statements and general safety precautions for products requiring them are to be grouped together with those specified in the section on safety directions, and placed on the label immediately after the heading ‘SAFETY DIRECTIONS’.

Where an individual warning statement or general safety precaution from the FAISD Handbook is effectively duplicated by the requirements for safety directions, the direction need only appear once. Warning statements and general safety precautions with the safety directions required for a product will be assessed during the product evaluation.

First aid instructions specify the initial action to be taken to counteract the effects of exposure to the product. The instructions may include decontamination measures, administration of antidotes or medical treatment advice.

The label must include first aid instructions from the FAISD Handbook. First aid instructions are substance-specific. ‘First aid’ statements for a product are determined by the APVMA during product evaluation.

The first aid instruction ‘a’, should appear on the label of agricultural and veterinary chemical products (unless replaced by instructions ‘i, o or z’). First aid instruction ‘a, i or o’ apply only to substances in agricultural and veterinary chemical products registered by the APVMA when present in concentrations at which they would be scheduled as poisons in the Poisons Standard.

Examples of commonly used ‘First aid instructions’ statements:

• Statement ‘a’: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11 26, New Zealand 0800 764 766.
• Statement ‘i’: If poisoning occurs, get to a doctor or hospital quickly.
• Statement ‘o’: If sprayed on skin, wash thoroughly. If sprayed in mouth, rinse mouth with water.
• Statement ‘z’: First aid is not generally required. If in doubt, contact a Poisons Information Centre (e.g. phone Australia 13 11 26, New Zealand 0800 764 766, or a doctor).

For products that are only registered in Australia, the New Zealand Poisons Information Centre is not required either on the approved label or the marketed label.

Statements additional to those listed as mandatory in the FAISD Handbook may be included on the label, provided they are reasonable and do not contradict the mandatory statements. These statements may be determined during product evaluation, chemical review or may be proposed by an applicant to manage a specific user exposure risk.

For hazardous substances, ‘Additional user safety’ statements may include reference to the safety data sheet (SDS) and/or where to get a copy of the full SDS. Users of the product should be made aware of their obligations under relevant state or territory occupational health and safety legislation. When an SDS is required to be obtained under that legislation, product labels may refer users to the SDS by including a statement such as the following:

Additional information is listed in the safety data sheet (SDS)

The label must include suitable instructions about the proper method to dispose of used and/or unused product and any other statements required to manage risk to the environment. ‘Environmental protection’ statements are those relating to the protection of wildlife, fish, crustaceans and the environment. These statements are determined by APVMA during product evaluation.

An example ‘Environmental protection’ statement is:

13.5. Hormonal growth promotants

The following statements must appear under the ‘Disposal’ heading:

13. Disposal statements

You must include suitable instructions for the storage of the product on the label. These statements are determined by the APVMA during product evaluation and reflect the conditions studied during the generation of stability data.

‘Storage’ statements are instructions on the appropriate temperatures, light and environmental conditions for the storage of a product, as determined by stability studies.

For example, one of the following standard statements may be appropriate:

• The APVMA may require other storage instructions, for example:

• If determined during product evaluation, sterile products (including vaccines) for multi-dose use may require additional storage conditions related to the in-use shelf life. The storage conditions of the broached container must be included in addition to the unopened container (if this differs).
• Certain products or actives (for example, injectable products containing pentobarbital) must include additional storage instruction to avoid misuse:

The following statement may be included when the product is unscheduled:

The label must contain the name and address of the person who is primarily responsible for marketing the veterinary chemical product. The address shown must be a street address (not a post office box) in Australia and a contact telephone number must also be included.

For example, this statement may be qualified by the words:

• Packed for
• Distributed by
• Licensed to
• Manufactured by
• Sold by

You may also show other information on labels, including details of branch offices, local agents or distributors, phone numbers and website addresses. The APVMA will not check these details for approval.

The label must contain the distinguishing number of the label for the product. This is a number unique for each label that is allocated by the APVMA.

The APVMA label approval number must be preceded by either of the following statements (depending on label space):

The expiry date must be displayed on the label and/or container on all veterinary chemical products based on the shelf life as determined by the by the APVMA.

The expiry date is the date (month and year, or day, month and year) after which the product must not be used. For example:

Expiry dates must be preceded by either of the following statements or by a suitable prefix:

The date of manufacture may also be included on the marketed label and be clearly identifiable.

The label must state the batch or lot number for the product. This must be shown on the label or be suitably affixed to the label or the container before containers of the product are released for supply.

The batch or lot number is the number or letters, or a combination of numbers and letters, in English, by which the manufacturer uniquely identifies each production batch. It enables the tracing of a particular batch or lot from manufacture through distribution to end-use.

A batch or lot number must be preceded by either of the following statements:

or a suitable prefix:

The appropriate batch or lot number must be printed adjacent to this expression or prefix, to ensure it is not confused with any other numerical codes.

Please keep in mind the following advice when adding an expiry date, or a batch or lot number statement.

The batch or lot number and expiry date should appear and be grouped together with the APVMA approval number. When they do not appear in this actual position the information must be easy to find. Appropriate wording to specify the actual position would be:

Other information to meet the requirements of other regulators – such as emergency and transport advice and hazard symbols, warranty statements or disclaimers, as well as logos such as drumMUSTER and barcodes – may be included on the marketed label, provided they are shown in a distinct panel or clearly delineated box, and not incorporated under the same headings as the APVMA-required directions or instructions approved by the APVMA. This additional information should not be supplied to the APVMA as part of label approval (i.e. E-label template) as it does not constitute relevant particulars.

Emergency and transport advice on the steps to be taken in the case of leakage, spillage or fire should be included on the label when required under the ADG Code.

Emergency information statements should include the information required by the ADG Code, or its successor, which is incorporated into relevant state legislation. The information should be included on the label in a clearly defined emergency information panel or delineated box.

If the product is classified as a hazardous chemical under the Work Health and Safety Regulations, there are likely to be labelling requirements in those regulations. You should make enquiries about these requirements with Safe Work Australia or the state or territory workplace health and safety agencies. Any required statements must be shown in a distinct panel or clearly delineated box. This information does not constitute a relevant particular and must not be incorporated into the APVMA-required safety directions or other instructions approved by the APVMA.

Holders should also note the Commerce (Trade Descriptions) Act 1905, administered by the Australian Customs and Border Protection Service, establishes rules for the labelling of imported goods that relate to the country of origin.

Note it is the responsibility of the applicant to meet these requirements; however, the information will not be assessed or approved as part of the APVMA’s approval process. Please make sure the other label information is not contrary to the relevant label particulars that are approved by the APVMA and are placed in such a way as not to interfere with the layout and presentation requirements in this code.