Veterinary Labelling Code

Chapter 1.   INTRODUCTION

The assessment and approval of labels is a key aspect of the registration of veterinary chemical products by the APVMA. National legislation that applies to the assessment and approval of labels for veterinary chemical products includes:

• Agricultural and Veterinary Chemicals Act 1994;
• Agricultural and Veterinary Chemicals Code Act 1994 and its schedule, the Agricultural and Veterinary Chemicals Code (the Agvet Code); and
• Agricultural and Veterinary Chemicals Code Regulations (the Regulations).

The Code of Practice for Labelling Veterinary Chemical Products (the Vet Labelling Code) provides comprehensive guidelines and examples for applicants preparing labels for veterinary chemical products. All the key information required on labels is outlined in this code of practice.

The Vet Labelling Code does not, however, attempt to include all the situations and all the specific words that may be included on the labels. The Code will indicate main subject areas and where prescribed or required wording applies but in many cases only examples of suitable wording are listed. Where the information provided in this code is insufficient for an applicant to design a satisfactory label they should contact the APVMA for advice. Applicants wishing to have a label approved under the National Registration Scheme should be aware that the APVMA can only assess a label if it is part of a complete application.

1.1.     Products covered by the Vet Labelling Code

This publication covers the labelling requirements for veterinary chemical products as defined in Section 5 of the Agvet Code (Appendix 11). The Regulations may declare a class of substances or mixture of substances to not be a veterinary chemical product. The Regulations should therefore also be consulted to determine whether a product is deemed to be a veterinary chemical product and therefore subject to this labelling code. If uncertainty exists about whether a product is a veterinary chemical product, the Agricultural and Veterinary Chemical Evaluation Section of the APVMA should be contacted.

1.2.     What is a label?

A label is defined by Section 3 of the Agvet Codes (Appendix 11). A label includes the written, printed and related graphic matter on, or firmly attached to:

• the immediate container (the container which is in physical contact with the veterinary chemical product e.g. bottle, blister pack, tube, syringe etc.);
• the primary pack (the packaging in which a single sale unit of the immediate container is supplied); and
• a tag or leaflet supplied with each single sale unit (where these are appropriate).

The label must be capable of remaining attached for a period that is at least equal to the reasonably expected life of the particular product. All information required on a label should be on the primary pack. If there is no primary pack, then it is expected that the immediate container should be labelled with as much information as possible (see Chapter 3). Certain information may appear on a tag or leaflet when space is limited. The APVMA will consider each situation on its merits. All parts of labels as defined above should be submitted for approval.

The label may often be the only source of information, instruction and advice to the user of a product. It is therefore important that, when preparing a label, the designer consider:

• how best to utilise the available space;
• what must be put into that space; and
• where to place the information

1.3.     Label to be securely attached

Every label for a product must be printed on or securely attached to the outside of the container or pack of the product. Leaflets or booklets, if used, should be attached to the container in plastic pockets or suitable secure holding methods eg within the primary pack.

1.4.     Printing and print size

Except as otherwise directed, all wording must be:

• in the English language;
• on the outside face of the label or container;
• in durable characters;
• in such colours or colours as to provide a distinct contrast to the background colour;
• have letters not less than 1.5 mm in height, unless otherwise specified in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The minimum print size should only be used where space is limited. Larger print, that is print which is 2 mm or greater, is easier to read. Users are more likely to read larger print and follow instructions.
• letters with ascenders or descenders, such as b, f, g, h, l, t etc are to be a minimum of 1.5 mm. In printing terms an upper case of 1.5 mm equals 6 points. Letters without ascenders or descenders, such as a, e, i, o, u, m, r etc are to be a minimum of 1 mm. Use of 6 point type provides lower case ‘o’ or ‘n’, for example with a height of 1 mm.

1.5.     Submission of draft labels

The applicant is to submit text and format of a draft label or suite of draft labels (if different pack sizes require different wording). Current labelling requirements are described in MORAG Volume 5: Label Approval Process. The following provides guidance to the applicant on submissions:

1. The same label can include more than one pack size provided that the information is the same for each pack size. An appropriate format for the inclusion of all pack sizes on one label is 5L [10, 15, 20L].
2. Draft label(s) must be ‘version controlled’. This requires the draft label(s) to be serially numbered and dated (with the day of preparation) on each page of the draft label(s).
3. Page numbering of labels is consecutive and not separated into pack sizes viz. a 20 page suite of labels and leaflets would be notated as 1 of 20, 2 of 20, 3 of 20 etc. up to 20 of 20; not several labels each commencing with page 1 for each pack size.
4. All internal company related references and printing instructions must be clearly separated from the draft label text by lines, boxes, columns or other suitable notation.
5. Submission of draft labels requires two copies (where appropriate) – one unmarked and one with highlighted changes for easy reference.
6. Labels sent by facsimile or email are not acceptable for final approval purposes. Labels must be received in good quality type or printing. Labels sent by facsimile are only useful during the negotiating and checking phases of the label approval procedure.
7. APVMA Approval Number on draft labels should have the month and year left blank as this will be inserted by the APVMA upon approval eg APVMA 65432/, or APVMA Approval No. 65432/

1.6.     Reference materials

The details of documents referred to in this Code are given in the References Section. Bibliographic details and, where appropriate, ISBN and purchase information are also given. Applicants should be aware that many of these documents are updated regularly (hence dates are not supplied in the text). It is therefore important to ensure that the latest editions of reference materials are obtained.

Chapter 2.   INFORMATION REQUIRED ON LABELS

The Agvet Code stipulates that a label must contain adequate instructions (see Appendix 11) to cover every point relevant in the following list:

• Circumstances in which the product should be used;
• How the product should be used;
• Times when the product should be used;
• Frequency of the use of the product;
• Withholding period after use of the product;
• Re-entry period after the use of the product;
• Disposal of the product when it is no longer required;
• Disposal of the containers of the product;
• Safe handling of the product and first aid in the event of an accident caused by the handling of the product; and
• Any other matters prescribed by the Regulations.

The label must contain specific labelling information for each of the points listed above, if applicable. This information is to be placed on the label in the order listed below. The figure in brackets after each requirement indicates the relevant section in Chapter 2 that gives details on content and layout.

1. Signal Heading(s) (2.3–2.6);
2. the statement FOR ANIMAL TREATMENT ONLY (2.4(e) and-2.6(e));
3. Distinguishing name of product (2.7–2.9);
4. name(s) and amount(s) of active constituent(s) and any scheduled inert or non-active constituent(s), e.g. solvent(s) (2.10–2.16);
5. statement of claims or the circumstances in which the product should be used (2.17-2.18);
6. contents (2.19-2.20);
7. Directions for Use and other essential product information needed for proper administration, e.g. restraints, contraindications, precautions, adverse reactions, dosage, frequency of use, route, compatibility statements etc. (2.21–2.36);
8. Withholding Period statements – for food producing animals and horses (2.37–2.41);
9. First Aid instructions, Safety Directions, warning statements and general safety precautions, if required (2.42–2.47). The same section on the label may include manufacturer statements under ‘Additional Safety Information’;
10. reference to the Material Safety Data Sheet, if required (2.48–2.50);
11. precautionary environmental statements, if required (2.51–2.53);
12. Disposal statements (2.54–2.56);
13. emergency and transport advice, if required (2.57–2.59);
14. company name and Australian street address (2.60–2.62);
15. Storage instructions (2.63–2.65);
16. APVMA approval number (2.66–2.68);
17. Batch Number (2.69–2.71);
18. Expiry Date (2.69–2.71)

Warranty statements, disclaimers regarding liability, label printing/artwork, company logos or bar codes may also be included. These must be placed in such a way as not to interfere with the layout of the requirements listed above.

The location on the label for items a, b, c and d must comply with instructions in the Standard for Uniform Scheduling of Drugs and Poisons (SUSDP). Items o, q, and r are to be grouped together, as are items g and h. Item p can either be grouped with o, q, and r or placed in an easily locatable position, preferably at the bottom of a panel. The location of other items on the label is at the discretion of the applicant. For further information relating to label layout of particular packaging types refer to Chapter 3.

2.1.     Signal headings

Definition

Signal Headings are the words relating to the Schedule in which a poison is included plus any other cautionary statements as specified in the SUSDP.

Instructions

1. Signal Headings must appear separate lines of the main panel
2. Signal headings must be printed in bold-face sanserif capital letters in print size as specified in the SUSDP and summarised in 2.6
3. Signal Headings for products containing scheduled poisons are as follows:
   
   Schedule 4:
   PRESCRIPTION ANIMAL REMEDY
   KEEP OUT OF REACH OF CHILDREN
   
   Schedule 5:
   CAUTION
   KEEP OUT OF REACH OF CHILDREN
   
   Schedule 6:
   POISON
   KEEP OUT OF REACH OF CHILDREN
   
   Schedule 7:
   DANGEROUS POISON
   KEEP OUT OF REACH OF CHILDREN
   
   Schedule 8:
   CONTROLLED DRUG
   POSSESSION WITHOUT AUTHORITY ILLEGAL
   KEEP OUT OF REACH OF CHILDREN
4. If Safety Directions are required because they have been listed in the FAISD Handbook, or set during the registration and evaluation process, the cautionary statement READ SAFETY DIRECTIONS BEFORE OPENING OR USING, or if space is limited READ SAFETY DIRECTIONS must appear on a separate line or lines immediately below the cautionary statement KEEP OUT OF REACH OF CHILDREN (for products containing scheduled poisons) or above the FOR ANIMAL TREATMENT ONLY statement (for products not containing scheduled poisons).
5. The statement FOR ANIMAL TREATMENT ONLY is required as part of the Signal Heading of all veterinary chemical products. It must be placed immediately below any required other signal words, expressions or statements (including the expressions KEEP OUT OF REACH OF CHILDREN and (if required) READ SAFETY DIRECTIONS BEFORE OPENING OR USING or READ SAFETY DIRECTIONS) with no other word on the same line.
6. Other words and cautionary statements may be required in the Signal Headings depending on the types of constituents in a particular product. Applicants should check the current edition of the SUSDP for the relevant requirements.

Points to note

1. The use of the statement KEEP OUT OF REACH OF CHILDREN in the Signal Headings is restricted to products that contain one or more scheduled poisons. For products that do not contain scheduled poisons applicants may incorporate this statement with the Storage Instructions.
2. When space on a label is restricted, for example ampoules, pre-filled syringes and injection vials of 1mL or less or measure packs the SUSDP allows for a reduced label instructions on that container. Applicants should check the current edition of the SUSDP for the relevant requirements.

The SUSDP also stipulates the printing requirements for Signal Headings and cautionary statements. These are summarised below however applicants should consult the current edition of the SUSDP for more detailed information.

1. The SUSDP specifies that any word, expression or statement required by the Standard must be written:
   • on the outside face of the label or container;
   • in the English language;
   • in durable characters;
   • in a colour or colours to provide a distinct contrast to the background colour; and
   • in letters at least 1.5 mm in height (or at least 1 mm in height for containers of 20 mL or less).
2. PRESCRIPTION ANIMAL REMEDY, CAUTION, POISON DANGEROUS POISON and CONTROLLED DRUG are to be written:
   • in bold-face sanserif capital letters of uniform thickness; and
   • in letters at least half the height of the largest letter or numeral on the label but need not be larger than (i) 6 mm on labels for packages having a nominal capacity of ≤2L; or (ii) 15 mm on labels for packages having a nominal capacity of >2L.
3. KEEP OUT OF REACH OF CHILDREN is to be written:
   • on a separate line immediately below the signal word(s);
   • in bold-face sanserif capital letters of uniform thickness; and
   • in letters at least four-tenths the height of the letters used for the signal word or words.
4. READ SAFETY DIRECTIONS BEFORE OPENING OR USING or READ SAFETY DIRECTIONS is to be written:
   • on a separate line(s) immediately below the cautionary statement KEEP OUT OF REACH OF CHILDREN; or if other cautionary statements are required to be on the line immediately below KEEP OUT OF REACH OF CHILDREN, immediately below those statements; and
   • in bold-face sanserif capital letters of uniform thickness; and
   • in letters at least four-tenths the height of the letters used for the signal word or words.
5. FOR ANIMAL TREATMENT ONLY is to be written:
   • in bold-face sanserif capital letters of uniform thickness; and
   • in letters at least 1.5mm in height.

2.2.     Distinguishing name of the product

Definition

All words symbols and numbers that appear between FOR ANIMAL TREATMENT ONLY and the active constituent statement are considered to be the distinguishing name of the product.

Instructions

1. The name should be distinctive and not misleading. It is the applicant’s responsibility to ensure that the product name is sufficiently unique as to not cause confusion in the market place.
2. The name should also describe the physical form and route of administration and possibly its intended purpose e.g. oral powder, feed additive, oily injection, inhalant, tablet, spray-on, dip, oral paste, dip and spray, pessary, injectable suspension, oral suspension etc.
3. A simple approach is to use a trade name (if applicable) followed by the brief description.
4. Where the product name is not distinctive, such as a generic active constituent, the company name could, for example, be incorporated into the product name to distinguish it from other products having similar names.
5. Products for over-the-counter sale are normally named according to their purpose, e.g. ‘Pour-on Worm Treatment for Sheep and Goats’. The product name should be distinctive, descriptive and concise. It is not necessary to detail a medicinal claim in a product name where this is given in an abbreviated statement of claim elsewhere on the main panel of the label.
6. When numbers are used as part of the distinguishing name they should relate to the level or concentration of active constituent in the product expressed in metric units (not percentages) or as otherwise determined by the APVMA. Exceptions permitted by the APVMA may include references to dose rates in relation to weights of target animals in the product name, e.g. ‘Tickex 20’ where a unit of the product was the dose for a 20 kg dog or ‘5 in 1’ for multivalent vaccines.
7. The word ‘Plus’ in a name may be approved when another active constituent is added to a currently registered product to extend the medicinal claim.
8. In this instance the name of the new active constituent or class of constituent must be listed after ‘Plus’.
9. The word ‘Plus’ in a name will not normally be approved in other circumstances.

Points to note

1. For currently registered products where an application is made to update the label or for approval of a label change of a technical change it should be noted that no words or figures may be inserted in, or deleted from, the distinguishing name of a product as approved at registration. The word ‘and’ in a registered product name can be interchanged with ‘&’ or vice versa.

2.3.     Active constituent(s) and scheduled non-active constituent(s)

Definition

An active constituent is the substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the product as a veterinary chemical product. Scheduled non-active constituents are constituents in the formulated product that are not responsible for the biological or other effect but are listed as a scheduled poison in the SUSDP.

Instructions

1. The active constituent and scheduled non-active constituent statement(s) are to be written immediately below the distinguishing name of the product and parallel to other printed matter.
2. Use of the heading ‘Active Constituents’ is optional.
3. If the distinguishing name of a product includes the name(s) of the active constituent(s) and concentration or amount, this statement need not be repeated.
4. The active constituent(s) and scheduled non-active constituent(s) must be listed as the Australian Approved Name and quantity in metric units. Vaccines must state the end-of-shelf-life potency or titre of all active constituents, as well as the scheduled non-active constituents and the preservative used (refer to Appendix 8). Direct-fed microbials require a statement on the count of viable microorganisms. Enzyme based products should be expressed in appropriate units of biological activity such as activity units per gram. The active constituent and scheduled non-active constituent statement(s) must be printed in accordance with the requirements of the SUSDP.

Name of active constituent(s) and scheduled non-active constituents

1. The name for scheduled active constituents and non-active constituents must be the name specified in the SUSDP.
2. The preferred name for active constituents for which a poison schedule does not apply is
   1. The name in the Therapeutic Goods Administration (TGA) Approved Terminology for Drugs.
   2. 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 US Pharmacopoeia.
   3. The name approved by Standards Australia.
   4. The name given by the International Organisation for Standardisation.
   5. The name given by the British Standards Institution.
   6. The accepted scientific name (Chemical Abstracts or International Union of Pure and Applied Chemistry) or the name descriptive of the true nature and origin of the constituent.

A trademark or trade name may not be used as an approved name of an active constituent (unless relinquished by the owner, in which case it ceases to be a trade name).

Expression of quantities

The quantities of active constituents and scheduled non-active constituents should be expressed as follows.

1. The amount must be expressed in metric terms according to the formulation.
2. All units of mass or volume should be written in full or represented by their correct symbols such as gram or g, litre or L, for example:
   1. gram/litre or g/L for large volume liquid preparations (≥1L);
   2. gram/kg or g/kg for large volume solid preparations such as premixes;
   3. mg/mL for injectable preparations and small volume liquids (<1L);
   4. mg/g for small volume solid/semi solid preparations;
   5. g/kg for aerosol preparations;
   6. µg should be used as the abbreviation of microgram.
3. Expressions for a product packed in discrete dosage units or for small volume liquids (<10mL) include:
   1. each tablet/capsule/caplet contains [...] mg (active constituent); or
   2. each mL contains [...] mg (active constituent).
4. 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.
5. Vitamins A and D must be expressed in International Units (IU) while other vitamins are to be expressed in metric units.
6. The active constituents statement for direct-fed microbials should read as – ‘Contains a source of live (viable) naturally occurring microorganisms’. This should then be followed by a listing of each of the microorganisms and their quantities such as colony-forming units per gram.
7. Salts or esters of active constituents that are used in a formulation should indicate the amount of active moiety present and nominate the salt or ester present, for example:
   • 110 mg/mL Hydroxyprogesterone hexanoate (equivalent to 100 mg/mL Hydroxyprogesterone)
     or
   • 100 mg/mL Hydroxyprogesterone (as the hexanoate)
8. Solvents should be given as:
   • Solvent: […] g/L or g.litre liquid hydrocarbons
   • Solvent: […] g/L or g/litre toluene

Format for constituents of mixtures

Constituents of mixtures should be expressed as follows.

1. Active constituents should be shown in a column or sequence in descending order based on the concentration of each active constituent present.
2. Where synergists are present they should be shown after the main active constituent(s) even when at a higher concentration than the active constituent(s)
3. Where scheduled non-active constituents are present they should be shown after the active constituent(s) (and synergists, if applicable) even when at a higher concentration than the active constituent(s)/synergist(s).
4. Vitamin and mineral preparations should have the constituents listed in the following order:

• fat soluble vitamins
• water soluble vitamins
• minerals
• antioxidants
• other ingredients.

Anticholinesterase compounds

If the active constituent is an organophosphorus compound or carbamate the expression AN ANTICHOLINESTERASE COMPOUND must appear in brackets immediately below the approved name of the poison or list of declared contents. This statement must be printed in accordance with the requirements of the SUSDP.

‘Also contains’ statement

1. The use of the 'Also Contains' statement on labels usually refers to those formulation ingredients that are not usually directly related to the claim, but the inclusions are considered necessary by the APVMA.
2. The use and appearance of 'Also Contains' statement is determined by the APVMA on a case-by-case basis.
3. Amounts of these ingredients should be shown or as determined by the APVMA on a case-by-case basis.
4. The statement is most commonly used in cosmetic and nutritional products e.g. a product containing thiamine, magnesium, and tryptophan approved for use in nervous horses may 'also contain' other vitamins, minerals or amino acids that have no role in nervous conditions but are present at normal supplementary dietary levels.
5. The ‘Also Contains’ statement is not considered appropriate for non-active constituents

2.4.     Statement of claims

Definition

A claim(s) is a brief statement outlining intended use of the product that has been validated through efficacy and safety data.

Instructions

1. All labels must have (an) accurate and moderately worded claim(s).
2. Placement is beneath the active constituent statement. All labels must have an accurate and moderately worded claim(s).
3. The claim(s) must not imply excessive efficacy or make a comparison with other competing products.
4. The claims statement should be positioned beneath the active constituent statement where possible.
5. The name(s) of the intended target species (e.g. dog, cat, horse, sheep etc.) should be included in the statement of claims on the main panel. This is preferable to including the target species in the product name.
6. An abbreviated claims statement, which may or may not be part of the product name, can be used provided it is expanded elsewhere on the label/leaflet.
7. All claims should be stated in specific terms. For instance, broad terms such as ‘worm control’ are not acceptable, except in the case of antibiotics where groupings such as ‘gram negative’ may be used.
8. The Linnaean scientific name (bracketed; in italics or underlined) and common name used in Australia of each pest, parasite or disease organism for which control is claimed should be given in the claims statement. The Linnaean scientific name(s) is optional in the abbreviated claim if included in the extended claim on the ancillary panel or on the leaflet (where space is limiting).

2.5.     Contents

Definition

Statement showing the quantity of an approved formulation in its container.

Instructions

1. The contents statement is usually placed below the statement of claims. Where the distinguishing name of a product includes the contents statement, this statement need not be repeated.
2. The heading ‘Contents’ is optional.
3. Statements of weight and quantity must comply with relevant State and Territory legislation on weights and measures.
4. Contents are to be stated in metric units, except in the case of tablets, capsules, oblets, doses, etc. where the count must be given (for example, 100 tablets).
5. All units of mass or volume are to be written in full or represented by their correct abbreviated symbols. Relevant weights and measures legislation provides this information.
   1. Liquids are shown as mL (millilitre) or L (litre).
   2. Solids, semisolids, pastes or aerosols are shown as g (gram) or kg (kilogram) NET.
   3. All units of mass or volume are to be written in full or represented by their correct abbreviations
6. Applicants are advised to consult the SUSDP and relevant weights and measures legislation.

2.6.     Directions for use

Definition

Directions for Use are instructions and statements on how to use a product correctly.

Instructions

1. The heading DIRECTIONS FOR USE should appear in bold-faced capital letters.
2. Statements should be simple, clear and concise and provide at least the minimum information necessary.
3. If a product is not registered in all States and Territories, the first statement in the Directions for Use must indicate the particular States of registration.
4. Sub-sections, as required should be presented on the label in the following order – restraints, contraindications, precautions, overdosage, mandatory warnings, side effects, dosage and administration, general directions, general limitation statement and withholding periods.
5. The use of sub-headings shown below is optional except where stated.

2.7.     Restraints

Definition

Situations in which the use of a product has an absolute limitation or restriction (related to residues, antibiotic resistance or environmental issues) that is not stated in the claim.

Instructions

1. Statements should appear directly under the heading for the Directions for Use for products registered in all States.
2. Statements should appear directly under the State registration statements for products not registered in all States.
3. Statements must appear under the heading Restraints. The heading is to be written in bold-faced letter of not less than 1.5mm in height
4. Statements must be placed in bold-faced letters and not less than 1.5mm in height.
5. Any restraint statement relating to withholding periods must be included (see also 2.37-2.41).
6. For all products intended for intravenous administration or stomach tubing (excluding Schedule 4 or Schedule 8 products) or any other products as directed by the APVMA, the statement FOR USE ONLY BY OR UNDER the direction of, a registered veterinary surgeon should appear immediately below the Directions for Use heading. Regardless of the size of the pack, the statement should be placed on the main panel of the label
7. Restraint statements typically begin with text such as DO NOT USE, NOT TO BE USED or USE ONLY.

2.8.     Contraindications

Definition

Contraindications indicate when the product should never be given or is generally not indicated when there are target animal safety issues.

Instructions

Contraindications must be specifically outlined. A contraindication statement should begin with text such as – This product is contraindicated for use in [species] with [disease or condition].

2.9.     Precautions

Definition

Precautions statements are relevant for incompatibility or interactions that occur when the product is simultaneously administered with another product, if the product influences laboratory test results or if the product affects the physiological status of the pregnant or lactating female and / or foetus or neonate.

Instructions

1. Precautions statements should be grouped according to outcome, and the mechanism of action (where known) to be explained.
2. Precaution statements are to begin with:
   1. ‘Use with caution’ when describing particular populations or clinical situations where dosage reduction is required.
   2. ‘Check the following before use’ when describing particular investigations that may need to be carried out.
3. Calcium borogluconate and other metabolic disease remedies must carry the following statement:

   Use of this product intravenously may be hazardous to the animal and advice from a registered veterinary surgeon should be sought.
   
   Refer to Appendix 1 for further instructions.

4. Off-label use of antimicrobial products registered for use in food-producing animals carries the greatest risk of residue violations. All prescription antimicrobial products must carry the mandatory warning statement.

   Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may require extending the approved withholding period.

5. Precautionary statements have been developed for many other types of products. Applicants should refer to the relevant appendix in this publication for statements required.

2.10.   Side effects

Definition

Statements on side effects or adverse drug reactions alert the end-users of effects that may occur after administration of a product to an animal and are demonstrated by unexpected clinical effects such as anaphylaxis.

Instructions

Statements should indicate the severity, clinical importance, frequency and treatment of the effects.

2.11.   Dosage and administration

Definition

Instruction on the specific dose and/or inclusion rate for each species and/or claim, method and route of administration, frequency of dose, duration of course and any special instructions relating to dosage and administration.

Instructions

1. Relevant mixing directions should be given first in uppercase and bold type, if the sentence is brief (e.g. SHAKE WELL BEFORE USE, or USE ALL PRODUCT WITHIN 24 HOURS OF MIXING). If the sentence is long, then lowercase and bold type is preferable (e.g. Shake well before use and use all product within 24 hours of mixing).
2. Special instructions may include 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 relating to the administration with food.
3. A tabular format can be used for animal species (including sex, age, breed etc., where applicable) and the pests, parasites, diseases and conditions for which the product is intended (refer to Appendices 3 & 5 for parasiticides).
4. The Linnaean scientific name (either in italic font or underlined) and the common name used in Australia should be given for each pest, parasite or disease organism for which control is claimed if they are not listed elsewhere on the label.

2.12.   General directions

Definition

General directions includes other instructions or advice about administration of the treatment.

Instructions

1. Where mixing is concerned, compatibility statements will require approval before addition to the label.
2. Guidance notes for preparing general directions include:
   1. Statements about the requirement for a longer milk withholding period for whole herd treatments (‘blitz therapy’) may be approved for inclusion on a product leaflet/label if requested by the applicant.
   2. For advice on all injectable preparations likely to be used in food producing animals, see Appendix 1 (Note: Some products are exempt from these statements).
   3. Products which may be used in performance animals may carry the following statement:

      If used in performance animals, the regulations of the relevant authorities regarding medication should be observed.

   4. Products for use on wounds that contain alcohol as a solvent (≥20%) and may cause discomfort or delay wound healing must state:

      Repeated use on open wounds is not recommended.

2.13.   General Limitation statement

Definition

The General Limitation statement is a statement required under State pesticide legislation on product labels for ectoparasiticides used on both food and non-food producing species.

Instructions

1. The General Limitations statement is:

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

2. This statement should appear on product labels below the General Directions or under a Directions for Use table, but above the Withholding Period statement.

2.14.   Withholding periods

Definition

The Withholding Period is the minimum period which must 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.

Instructions

1. Statement(s) should be headed WITHHOLDING PERIOD(S).
2. Withholding Periods must appear in bold type and lowercase except where text, such as ‘DO NOT USE’ or ‘NOT TO BE USED’, must be inserted.
3. Statements on all products intended for food/fibre producing animals and horses must appear immediately after the Directions for Use section.
4. When a table is used to present Directions for Use, the Withholding Period statements must appear immediately after the table (and also the General Limitations statement, if applicable) and be followed by the General Directions.
5. A restraint statement (placed in the Withholding Period section) is used when a Withholding Period has not been set. This means that the product has a limited or restricted use in animals that are producing a specified commodity (refer to para. 2.15). The restraints statement must also appear in bold-faced type immediately after the Directions for Use heading (see also 2.7).
6. When the chemical or product is not for use in food/fibre producing species of animals, the statement ‘NOT TO BE USED in food producing species of animals’ should appear as a restraint statement under the Directions for Use heading. Antibiotics for ornamental fish should have the following restraint and Withholding Period statement.

   DO NOT USE in fish intended for human consumption.

7. Each withholding period statement should appear on a separate line. For example:

   WITHHOLDING PERIODS:
   MEAT: [appropriate statement/s]
   MILK: [appropriate statement/s].

8. Where a product can be used in or on more than one species or by more than one route of administration and the Withholding Periods are different, these differences must be clearly indicated on the label.
9. Where there are no Withholding Periods required, the statement WITHHOLDING PERIODS NIL or WITHHOLDING PERIODS: MEAT: NIL, MILK: NIL must be shown on the label.

2.15.   Withholding period statements required for food-producing species

Depending on the animal, statements may be required for the meat, and/or milk or eggs or meat alone of all food-producing species. Meat also includes offal.

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

MEAT

Ruminants, Poultry, Pigs and Others (including fish)

1. All products for use in or on meat-producing species of animals (e.g. cattle, sheep, goats, poultry, pigs and fish) are required to carry one of the meat Withholding Period statements.
2. It should be noted that all the food/fibre producing species (including milk producers) also produce meat and are considered to be producing meat throughout their lives.
3. The following Withholding Period statement should be used:

MEAT: DO NOT USE less than […] days before slaughter for human consumption

or

REMOVE ALL MEDICATED FEED/WATER […] days before slaughter for human consumption.

4. When harvesting fish for slaughter, degree days must 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.
   
   DO NOT USE less than […] degree days before harvesting [fish/abalone/etc.] for human consumption.

MILK

Non-Intramammary products

1. Milk Withholding Period statements are to be based on residue data for lactating animals.
2. All products for use in or on cattle, sheep and goats from which milk or milk products may be used for human consumption are required to carry an appropriate residue statement such as.
   
   Milk collected from [cows/ewes/does] within […] hours ([…] milkings) following treatment MUST NOT BE USED for human consumption or processing, or fed to bobby calves.
3. Where a Withholding Period is not established a restraint statement such as the following must be used.
   
   DO NOT USE [in/on] [cows/ewes/does] which are producing or may in the future produce milk or milk products for human consumption.
4. Depending on residue data available, one of the following restraint statements may be used instead of the one stated above.
   
   DO NOT USE [in/on] lactating or pregnant [cows/ewes/does] where milk or milk products may be used for human consumption.
   
   DO NOT USE [in/on] lactating [cows/ewes/does] or within […] days of [calving/lambing/kidding] where milk or milk products may be used for human consumption.
   
   DO NOT USE [in/on] lactating [cows/ewes/does] where milk or milk products may be used for human consumption.

Intramammary products

5. Products for use in lactating cows:
   
   Milk collected from cows within […] hours ([…] milkings) following treatment MUST NOT BE USED for human consumption or processing, or fed to bobby calves.
6. Products for use in dry cows:
   
   DO NOT USE in lactating cows or within […] days of calving. After calving, colostrum or milk from treated dry cows MUST NOT BE USED for human consumption or processing for […] hours ([…] milkings). If premature or unscheduled calving occurs, consult the prescribing veterinarian for advice on handling milk for bobby calves.

EGGS

1. Statements are required on all products for use in or on female poultry from which eggs or egg products may be used for human consumption.
2. Practically, producers cannot implement a Withholding Period other than a Nil Withholding Period. The following statement applies.
   
   WITHHOLDING PERIOD: EGGS: NIL
3. If a Nil Withholding Period cannot be set then the following restraint statement is required:
   
   DO NOT USE [in/on] birds which are producing or may in the future produce eggs or egg products for human consumption.
4. Depending on residue data available, one of the following restraint statements may be used instead of the one given above:
   
   DO NOT USE [in/on] birds during lay where eggs or egg products are to be used for human consumption or processing.
   
   DO NOT USE [in/on] birds during laying or within […] days of laying where eggs or egg products are to be used for human consumption or processing. If laying takes place within […] days, those eggs or egg products must not be used for human consumption or processing.

STATEMENTS REQUIRED FOR FIBRE-PRODUCING SPECIES

The following Withholding Period statements are required for the wool of sheep, and the fibre (e.g. mohair) of goats, alpacas and llamas.

WOOL/FIBRE:
DO NOT USE less than […] days/weeks/months before shearing or fibre collection.

Meat and milk Withholding Period statements are also required for these species.

STATEMENTS REQUIRED FOR HORSES

Although horses are not currently defined as a food-producing animal, horse products require a meat Withholding Period statement to appear on the product label. The statement is to begin with ‘MEAT WITHHOLDING PERIOD (HORSES):’. The inclusion of this header is particularly important for products not used in other meat-producing species. The meat Withholding Period statement for horses shows the minimum period that must elapse between the last treatment and slaughter for human consumption and not to the withdrawal period required by the relevant racing authorities to ensure that racehorses are presented for competition drug-free.

The options for this statement are:

1. For products containing:

• synthetic pyrethroids, aminoglycoside antibiotics or NSAIDs (unless residue data are available to support a WHP),
• 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 WHP), the following statement is required:

NOT TO BE USED in horses intended for human consumption.

2. For products where there are no residue concerns, for example:

• all products with actives/uses listed in Table 5 of the MRL standard,
• most vaccines (unless otherwise directed by the APVMA),
• many nutritional and general health care products, including most stockfoods, vitamins/mineral/amino acid supplements, electrolyte supplements, hoof and coat care products, grooming aids, rubefacients/liniments/poultices, skin emollients, antiseptics/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 PERIOD(S): NIL

3. For other products that are registered for use in food producing animals, a Withholding Period statement may be set on data/argument. If scientific data/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 […] days before slaughter for human consumption.
4. A default period of 28 days will be used where the Withholding Period for all of the food producing animals on the label is less than or equal to 28 days. Otherwise a default period of 60 days will be applied.

2.16.   Safety directions

Definition

Safety Directions are statements included on product labels which specify human hazards, precautions and instructions for handling, mixing and using the product safely.

Instructions

1. Safety Directions include general warnings, specific precautions and protective equipment relating to the safety of the user, but not warnings or precautions relating to flammability, spillage, container disposal or Withholding Periods.
2. Safety Directions must appear under the heading SAFETY DIRECTIONS. This heading is to be written in capital, bold-faced letters. Statements must be in clear letters of not less than 1.5 mm in height to enable users to readily locate and read them. They are to be clearly separated from the rest of the information.

Points to note

• Where Safety Directions are required the appropriate Signal Heading must also be included on the label (see see 2.3-2.6).
• Standard Safety Directions are listed by active constituent in the FAISD Handbook and are mandatory under the poisons and pesticides legislation.
• Safety Directions may be recommended when the active constituent is exempt from schedule or when no First Aid Instructions are listed.
• When there are no Safety Directions for a particular formulation type or constituent concentration, these may need to be set by TGA and National Occupational Health and Safety Commission (NOHSC) before a proposed label can be approved.

2.17.   First aid instructions

Definition

First Aid Instructions are statements included on product labels which specify 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.

Instructions

The First Aid statements must appear under the heading FIRST AID. The heading is to be written in capital, bold-faced letters of not less than 1.5 mm in height.

Points to note:

• Only scheduled poisons are required to have First Aid Instructions. Active constituents exempt from scheduling may have statement ‘a’ from the FAISD Handbook.
• Standard First Aid statements are listed by active constituent in the FAISD Handbook and are mandatory under the poisons and pesticides legislation.
• First Aid instructions may be required for Schedule 4 products depending on use pattern.

2.18.   Reference to material safety data sheets

Definition

Material Safety Data Sheets (MSDS) are published information sheets which identifies a chemical, states the health hazard that could be caused by the chemical, specifies the manner of handling the chemical in order to minimise hazards, states the general safety precautions to be adopted in the event of an emergency involving the chemical. The MSDS can include First Aid. The MSDS also contains information about the chemical and physical properties of the product or the active constituent.

Instructions

When MSDSs are required, a reference on the label to the sheets should be included under with the statement: ‘Additional information is in the Material Safety Data Sheet’.

Points to note

1. The Control of Workplace Hazardous Substances National Model Regulations and National Code of Practice (available from the Aus Info Shopfront) indicates when Material Safety Data Sheets for products are required.
2. It is the applicant’s responsibility to determine when MSDS are required.
3. Should the MSDS contain other relevant safety information, the applicant should include appropriate safety directions on the label under Additional Safety Information.
4. The information provided in the MSDS should be consistent with the information provided on the label.
5. When Material Safety Data Sheets are required, it is recommended that the distributor of the MSDS be indicated.

2.19.   Environmental statements

Definition

Precautionary environmental statements are those which relate to the protection of wildlife, fish, crustaceans and the environment.

Instructions

The statement(s) should have the appropriate heading, Protection of Wildlife, Fish, Crustaceans and the Environment. These statements are based on advice provided by Department of the Environment and Water Resources on a case-by-case basis.

2.20.   Disposal statements

Definition

Disposal statements provide advice on the appropriate method of disposing of unused chemical, spent dip wash and used containers. The APVMA requires that all veterinary chemical product labels carry suitable disposal statements. Inappropriate disposal of product containers can present a hazard to the environment and human safety. Consumers must be offered sufficient guidance for disposal of small or large containers and single-use product containers. Phrases such as ‘dispose of properly’ do not give sufficient guidance and will not be accepted.

Instructions

1. Use of the heading ‘Disposal’ is optional.
2. For pack sizes up to 1 kg, the disposal statement may be printed on the leaflet or primary pack instead of the immediate container label. If there is no leaflet or primary pack, the disposal statement must be on the label.
3. The following standard statements are guidelines only. The APVMA will consider modified statements.

Recyclable metal drums and plastic containers

Triple or (preferably) pressure rinse into the medicated water/dip/drench etc. Do not dispose of undiluted chemicals on-site. Return clean container for recycling where this is an option or for disposal at a landfill authorised to accept that waste. If neither of these options are available, bury the container below 500 mm in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers should not be burned.

Non-recyclable metal drums and plastic containers

Triple or (preferably) pressure rinse into the medicated water/dip/drench etc. Do not dispose of undiluted chemicals on-site.

Break, crush, or puncture and bury empty containers in a local authority landfill. If no landfill is available, bury the containers below 500 mm in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers and product should not be burned.

Plastic bags

Single rinse or shake remainder into the medicated water/dip/drench etc. Do not dispose of undiluted chemicals on-site.

Shred and bury empty bag in a local authority landfill. If no landfill is available, bury the bag below 500 mm in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and roots. Empty bag and product should not be burned.

Paper/cardboard containers and paper material bags

Shake and empty contents into medicated feed/water/dip/drench etc. Do not dispose of undiluted chemicals on-site.

Puncture or shred and bury empty container/bag in a local authority landfill. If no landfill is available, bury the container/bag below 500 mm in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and roots. Empty container/bag and left-over product should not be burned.

Formulations which are used without dilution

In the case of formulations which are not diluted with water before use (e.g. drenches), the following statement should replace ‘into the medicated water/dip/drench/etc.’ In some instances additional wording may be required:

Dispose of [name of product] in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and roots.

Formulations diluted before use

Dispose of diluted [name of product] in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation and roots.

Disposal of spent dips (where supporting data is provided)

If dipwash has to be pumped out after dipping, dispose of used wash by spreading onto pasture/soil clear of waterways, courses or drainage channels.

Small containers

For small containers (less than or equal to 1L or 1kg) the following statement should appear:

Dispose of empty container by wrapping with paper and putting in garbage.

Injectable/implant products and sharps

Where a disposable sharp is distributed with a product and sales of the product are not restricted to veterinarians, a disposal statement must be included on the label. The following statement is recommended:

Discarded needles/sharps should immediately be placed in a designated and appropriately labelled ‘sharps’ container.

This statement may also be printed on the label of a product where a disposable sharp is not included with the product but where one is normally expected to be used.

Live vaccine containers

Discarded vials/containers should immediately be placed in a designated and appropriately labelled ‘biologicals’ container. If this option is not available, bury the vial/container below 500 mm in a disposal pit specifically marked and set up for this purpose clear of waterways, desirable vegetation and roots.

Aerosol cans

The following disposal statement should appear on aerosol containers:

Aerosols should be completely emptied before disposal. Place empty can in household rubbish. Do not puncture or incinerate.

Returnable or recyclable containers

Container disposal is a rapidly changing area, particularly in view of the developments of the drumMUSTER Container Management Strategy by AVCARE NFF, VMDA and the Australian Local Government Association. Therefore, statements which focus on landfill and on farm (least preferred) disposal should only be seen as interim. Moves towards returnable containers and recycling of containers (in this preferred order) are to be highly encouraged.

Points to note

1. Applicants should determine whether the product and/or its packaging are eligible for inclusion in any National Container Collection program (eg. drumMUSTER) and should then select the appropriate disposal/recycling/return option.
2. Containers suitable for drumMUSTER are over 1 litre or kilogram in content and can be made from rigid metal or plastic.
3. Where a National Collection Program is in place (eg. drumMUSTER), a statement such as the following should be used:
   
   Containers should be taken after cleaning as indicated to an approved collection centre.
4. The drumMUSTER logo may be used. When the logo is included in an approved label, a sticker may be placed on the existing label, but may not obscure any of the words on the APVMA approved label. When the logo is incorporated into an existing approved label, the logo should be placed at the bottom left or right of the main panel, or adjacent to the emergency information panel on the ancillary panel. See NRA Gazette No. 2 1999 for further information.
5. Alternative chemical collection initiatives may also be appropriate.

2.21.   Emergency and transport advice

Definition

Emergency and transport advice is advice on steps to be taken in the case of leakage, spillage or fire must be included on the label when required under the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG Code).

Instructions

Emergency information statement(s) should include the information required by the ADG Code which is incorporated into relevant State legislation. The requirements of the ADG Code must be included on the label in a clearly defined Emergency Information Panel. The Emergency Information Panel is to include correct shipping number, UN number, class labels (hazard symbols) and emergency advice.

Points to note

1. It is the responsibility of the applicant to provide appropriate Emergency information.
2. The requirements set out in the ADG Code, or its successor, currently include correct shipping name, UN number and class labels (hazard symbols).

2.22.   Company name and street address

Definition

The name and full business address, i.e. Australian street address (not post office box) of the company (or person) responsible for registering and/or marketing the product in Australia must be shown on the label.

Instructions

1. The company name and street address must be included on the product label as, in an emergency involving a registered product, it is important that a responsible person can be contacted.
2. This statement may be qualified by the words ‘Packed for’, ‘Distributed by’, ‘Licensed to’, ‘Manufactured by’ or ‘Sold by’ etc.

Points to note

1. For scheduled products, apart from those in Schedule 4, either the company contact telephone number and/or the Poisons Information Centre contact number should be shown if not included under First Aid.
2. For all other products (those exempt from scheduling and Schedule 4 only) the inclusion of a contact number is optional.
3. If more than one manufacturing or distributing outlet exists, the street address of the principal Australian office should be used.

2.23.   Storage instructions

Definition

Storage Instructions are instructions on appropriate temperatures, light and environmental conditions for storage of product as determined by stability studies.

Instructions

Storage Instructions together with batch number, expiry date should be grouped together in an easily locatable position, preferably at the bottom of a panel unless otherwise specified.

Points to note

1. Storage Instructions reflect conditions studied in the generation of stability data. The following standard statements are given:

Store below -18°C (Deep freeze)

Store in liquid nitrogen or ‘dry ice’ and alcohol

Store below -5°C (Freeze)

Store between 2°C and 8°C (Refrigerate. Do not freeze)

Store below 8°C (Refrigerate)

Store below 25°C (Air conditioning)

Store below 30°C (Room temperature)

2. Storage conditions specifying temperatures over 30°C or below -18°C may be allowed subject to submission and review of stability data.
3. The APVMA may require other storage instructions, e.g. ‘store in a dry place, keep container closed, protect from light’.
4. KEEP OUT OF REACH OF CHILDREN may be placed with Storage Instructions if product is exempt from scheduling.

2.24.   APVMA approval number

Definition

The APVMA Approval Number is the unique product number followed by the month and year in which the label was approved by the APVMA.

Instructions

1. The Approval Number is to be preceded by ‘APVMA Approval No.’ or ‘APVMA’ where space is limited.
2. APVMA Approval Number can be grouped together with Storage Instructions, Batch Numbers and Expiry Date or placed in an easily locatable position, preferably at the bottom of a panel.

Points to note

1. Legislation requires that individual products have identifying APVMA Approval Number on the label for all pack sizes.
2. The format is as follows:

APVMA Approval No. [CRIS No.]/[pack size identifier]/[month and year]
e.g. APVMA Approval No. 63542/25L/0199 or APVMA 63542/25L/0199.

3. The APVMA Approval Number should occur once on each label component for the registered product packaging for each pack size. The APVMA label approval number should appear once on the immediate container label, once on the leaflet and once on the carton. Exceptions are very small containers, blister packs and foil strip packs. In the case of very small containers, blister packs and foil strip packs the APVMA Approval Number must appear on at least the outer packaging.

2.25.   Batch number and expiry date

Definition

The Batch 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 from manufacture through distribution to end use. The expiry date is the date (month and year) after which the drug should not be used. It is obligatory to show the expiry date on all veterinary chemical products in such a way that the meaning is clear (e.g. DEC96 or 12/96).

Instructions

1. The number or letter should be preceded by the words ‘Batch Number’ or ‘Batch’. The symbol (B) or [B] may be used for very small containers.
2. The date should be preceded by the words ‘Expiry Date’ or ‘Expiry’. The abbreviation Exp. or symbol (E) or [E] may be used for very small containers.

Points to note

1. Batch numbers, Expiry Date and Storage Instructions may be grouped together with the APVMA Approval Number.
2. Batch numbers and expiry details on a label can appear in a position other than grouped with Storage Instructions, provided that the actual position is near the Storage Instructions and the information is easy to find, read and understand. Appropriate wording to specify the actual position would be: ‘For batch and expiry see [...]’.
3. In addition to the Expiry Date, the Date of Manufacture (DOM) may also be shown.

2.26.   Certain statements prohibited

According to the Agvet Code, a label must not include any statement or expression that claims (however the claim is stated) that:

• the APVMA recommends the use of the product;
• the APVMA guarantees, warrants or assures the safety or efficacy of a product; or
• the product is natural, organic, safe, harmless, non-toxic, non-poisonous, non-injurious or environmentally friendly without qualification or with a qualification that is not acceptable to the APVMA.

Avoid certain terms and making claims that cannot be substantiated. The following sections are guidelines for users.

1. Superlatives and comparatives Words such as ‘the best’, ‘better’, ‘the most effective’, ‘superior control’, ‘super’, ‘top’, ‘best’, ‘highly’, ‘complete’, ‘extra’, ‘quality’, ‘care’, ‘essential’, ‘elite’, ‘premium’, ‘enhance’, ‘organic’ and ‘advance’ are usually unacceptable to the APVMA and should not be used. The terms ‘natural’, ‘naturally derived’, ‘nature’s way’ and similar words can only be used when all product constituents are of natural origin.
2. Imprecise words and phrases Words such as ‘booster’ (except vaccines), ‘conditioner’ (except as coat conditioner), ‘improver’, ‘tonic’, ‘pep’, ‘constitution’ and ‘worms’ are usually unacceptable. Words such as ‘plus’, ‘new’, ‘improved’ must be qualified. The use of the words ‘new’ and ‘improved’ is limited to six months after first sales of a product (or new formulation) and is not permitted in a product’s name.
3. Multiple meanings The use of words/phrases with multiple meanings which could be misunderstood are also unacceptable (e.g. ‘liver tablets’, ‘lamb paste’, ‘kidney mixture’ and ‘fly dust’).
4. Advertising statements Advertising statements are not permitted on labels. This includes cross-references to other products. An exception may be for compatibility purposes or pest/disease management where specific approval has been obtained from the relevant manufacturer(s). The name of a product not registered for use in a State or Territory is not acceptable on a label for use in that State or Territory.

2.27.   Use of logos and pictures

Logos are permitted, but must not interfere with the required label information.

Points to note

1. Logos and pictures should be pertinent to the product, and not confuse, mislead, be deceptive, or reduce the readability of the label. A label that involves a non-target species used as either a background graphic or logo must show enough information or instructions on the label to clearly indicate the species for which the product is intended.
2. Logos or pictures containing words are not to be positioned so they appear to be part of the product name (see 2.7–2.9). If a registered trade name is used as part of the distinguishing product name, the inclusion of a logo containing this trade name is acceptable, providing all other labelling requirements stated in this publication are met.
3. Company logos containing representations of animals that are not included in the claim for the product or other pictures that decrease the emphasis of Signal Headings should be located next to the company’s name and address (viz. well separated from the claim and product name). The size and prominence of the logo should not diminish Signal Headings nor be more prominent than the product name or other claims for use.
4. Australian-made claims (e.g. ‘Australian made’, ‘Made in Australia’, ‘Australian owned’, ‘Australian based and owned’ or similar words) or graphics (e.g. Australian flag, kangaroo, koala etc.) that implies a product is Australian may appear on a label in a position that does not interfere with the label’s function. This does not represent approval for the use or the accuracy of such claims. Relevant consumer affairs and trade practices authorities should be contacted for information about the valid use of these claims.

CHAPTER 3.   LABEL INFORMATION ON DIFFERENT PARTS OF THE LABEL AND LABEL LAYOUT

Chapter 2 provides details on the essential information to be included on a label. This chapter will provide guidance on the placement of this label information and requirements for different parts and different types of label.

The purpose of a label is to convey important information to the users. When designing a label it is important to consider how best to utilise the available space, what must be put into that space and where to place the information. The size of the label and the print size used should be proportionate to, and appropriate to, the size of the pack.

3.1.     Available space on labels

A panel refers to a distinct portion or division of the label. If space is limited, then it is unwise to place all required information on a single panel. Spreading information over two or more panels may be more appropriate. If the size or shape of a container cannot accommodate all required label information, or if the Directions for Use, Restraints, etc., are substantial, then a leaflet or booklet can be used in conjunction with the label. Leaflets or booklets form part of the registered label suite. They should only be used when the label or pack size combination provides insufficient space. Another alternative is to use a flag or “zip-seal” label.

• Paragraph 3.6 contains guidance on the acceptable labelling for very small containers i.e. containers with a capacity less than or equal to 10mL.
• Paragraph 3.7 contains guidance on the acceptable labelling for foil strip packs or blister packs.
• Paragraph 3.8 contains a sample leaflet that illustrates the order and positioning of leaflet information.
• Paragraph 3.9 contains instructions for a flag or “zip-seal” label.

When a product container is accompanied with a leaflet or booklet, the labels on the immediate container and primary pack should have the statement READ THE ATTACHED[ENCLOSED] LEAFLET[BOOKLET] BEFORE USING THIS PRODUCT in bold-faced sanserif capital letters of not less than 2 mm in height. This statement appears immediately above the Directions for Use heading.

3.2.     Main panel and ancillary panels

When there are two or more panels on a label, one panel is designated the main panel while the others become ancillary panels. The main panel is the most prominent panel and must, as a minimum, contain the following items:

• signal headings (if required);
• distinguishing name of the product;
• active constituent statement;
• statement of claims;
• contents.

The name and address of the company (or person) responsible for registering and/or marketing the product in Australia may also appear on the main panel depending on the available space. The remaining items are generally included on ancillary panels.

• Paragraph 3.4 contains a sample label which illustrates the order and positioning of the required information of a one panel label.
• Paragraph 3.5 contains a sample label which illustrates the order and positioning of the required information of a multi-panel label.

3.3.     Bar codes and hazard symbols

The need to include bar codes and hazard symbols on labels must be considered. Great care must be exercised to ensure that relevant legislation is not contravened, and that the information is readable.

3.4.     One-panel label

All information as detailed in Chapter 2 and other label instructions as per Appendices are required on a one-panel label. The format of each item must follow the instructions given in the relevant paragraphs in Chapter 2.

Figure 1: Suggested layout for a one-panel label

3.5.     Multiple-panel label

All information as detailed in Chapter 2 and other label instructions as per Appendices are required on a multiple-panel label. The format of each item must follow the instructions given in the relevant paragraphs in Chapter 2.

Figure 2: Suggested layout for a multiple-panel label

3.6.     Very small bottles or containers where space is limited

Restricted wording is permitted when space is limited on the immediate label of very small bottles or containers (up to 10 mL pack size). Provided that all information appears elsewhere on other parts of the label (eg primary pack or in a leaflet or booklet) the information to be shown on the immediate container label may be restricted to the following:

1. Signal Headings (when appropriate);
2. FOR ANIMAL TREATMENT ONLY;
3. distinguishing product name;
4. name(s) and amount(s) of active constituent(s) and any scheduled inert or non-active constituent(s), e.g. solvent(s);
5. contents;
6. reference to the primary pack or enclosed leaflet (as applicable);
7. Withholding Period statements and other limitations of use;
8. company identification (the address does not have to appear on the immediate container, but it must be shown elsewhere);
9. Storage Instructions;
10. Batch Number;
11. Expiry Date
12. Date of manufacture may also be shown; and
13. APVMA approval number (assigned at the time of label approval)

For small vials, e.g. 1 mL capacity, the APVMA will consider the positioning or wording of the information on the vial on a case-by-case basis. In these cases, it may be possible to alter the location of the active constituent statement or to abbreviate some components of the Signal Heading, the Withholding Period statement and company identification. Approval should be sought from the APVMA where label space is limited. Each case will be considered on its merits.

Reduced wording for containers from 10 mL to 100 mL will also be considered on a case-by-case basis. Larger containers should have all the information specified in Chapter 2 and other label instructions as per Appendices.

3.7.     Foil strip packs/blister packs

Foil strip and blister packages for tablets, capsules, caplets, pessaries etc. are required, as a minimum, to be labelled with the following information. A complete set of information must appear at least once on every strip of foil/blister pack enclosed within a primary pack.

1. FOR ANIMAL TREATMENT ONLY (the use of animal pictograms, or other wording which clearly show that the product is for animal use will be considered by the APVMA on a case-by-case basis)
2. distinguishing product name;
3. name(s) of active constituent(s) and the amount contained in each discrete dosage unit;
4. the words ‘Batch Number’ or ‘Batch’ or the symbol [B] or (B) followed by the batch number;
5. the words ‘Expiry Date’, ‘Expiry’, ‘Exp.’ or the symbol [E] or (E) followed by the expiry date;
6. Date of Manufacture may be shown in addition to the expiry date.

Foil strip and blister packs which are scored for sub-division require b and c above to appear in relation to every two dosage units and a, d and e to appear at least once.

3.8.     Leaflets/booklets

When a product container is accompanied with a leaflet or booklet all information as detailed in Chapter 2 and other label instructions as per Appendices should be included. The information is to be included in the leaflet/booklet even it is repeating information on the immediate container label.

Figure 3: Suggested layout for a leaflet

*Where the leaflet applies to more than one product, the product name and APVMA approval number for each product must be included.

3.9.     Zip-seal label

All information as detailed in Chapter 2 and other label instructions as per Appendices are required on a zip-seal label. A zip-seal label must remain attached to the container. The following information must be VISIBLE when the zip-seal label is folded.

1. Signal Heading;
2. FOR ANIMAL TREATMENT ONLY;
3. distinguishing product name;
4. name(s) and amount(s) of active constituent(s) and any scheduled non-active constituent(s);
5. statement of claims (may be abbreviated);
6. First Aid and Safety Directions (as required);
7. Batch Number;
8. Expiry Date (date of manufacture may also be shown);
9. Storage Instructions;
10. company identification (company name and street address);
11. contents;
12. APVMA approval number (assigned at the time of label approval)

Items a to j above must appear on the section of the label that is adhering to the container. This may result in certain information having to be repeated (unavoidably) within the zip-seal label. If further information is required than what is shown below, then use the instructions as per the multi-panel layout (3.5).

GLOSSARY

Active constituent(s)
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Agvet Code
The Agricultural and Veterinary Chemicals Code 1994; the schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

Ancillary panel
The panel, or panels, of a label other than the main panel (see Main panel). The ancillary panel, or panels, generally contain information relating to general instructions, directions for use, withholding period, safety directions, first aid, storage, disposal, APVMA number, batch number and expiry date etc.

Animal
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Anti-cholinesterase
A chemical found in humans and animals which interacts with or opposes the action of the enzyme cholinesterase. Cholinesterase helps regulate the activity of nerve impulses and is necessary for proper nerve function.

Claim
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Container
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Contraindications
A statement that outlines when a product is generally not indicated with regards to target animal safety.

Date of manufacture
The date on which the formulation of the product was completed. For immunobiological products, the date of manufacture is the date of the last potency test on the complete formulation.

Dermal use
Application to the skin usually for localised effect.

Distinguishing name
The full name of a product to be used on the product label which distinguishes it from other registered products.

Distributor
A person who imports, sells or otherwise supplies a poison/veterinary chemical product.

Expiry date
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

First aid instructions
Statements on labels which specify initial action to be taken to decrease the effects of exposure to the product. The instructions may include decontamination measures, advice to refer the victim for medical treatment and administration of antidotes (where applicable).

Food-producing animal
Refer to the Agricultural and Veterinary Code Act 1994.

Fibre-producing animal
Any animal used to produce fibre (including wool and mohair) for human use.

General Safety Precautions
See Safety Directions.

Good practice in the use of veterinary drugs (GPVD)
The officially recommended or authorised usage including withdrawal periods, approved by national authorities, of veterinary chemicals under practical conditions (sometimes referred to as Good Veterinary Practice - GVP).

Hormone
A substance that distributes throughout the animal and exerts specific effects in organs, tissues or body structures. Includes but is not limited to oestrogen, progesterone, testosterone, growth hormone and any non-naturally occurring hormone.

Immediate container
The container which is in physical contact with a veterinary chemical product (excepting pesticides).

Immunobiological product
Refer to the Agricultural and Veterinary Chemicals Code Regs 1994. Immunobiologicals include vaccines against diseases and normal or abnormal physiological conditions, antisera (hyperimmune sera) and monoclonal antibodies.

Label
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Level of active constituent
The concentration of the active constituent.

Main panel
Where there are two or more labels on a container or a label is divided into two or more panels, the main panel is the most prominent panel on a label and contains the signal word(s), cautionary statement for treatment of animals, the distinguishing name, the active constituent statement, claim(s) and contents.

Manufacturer
Person who manufactures, produces or packs a poison/veterinary chemical product.

Material Safety Data Sheet (MSDS)
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Measure pack
A sealed container which contains a measured quantity of poison/veterinary chemical product for use on one occasion and one or more of which is enclosed in a primary pack.

Medicated block or lick
Refer to the Agricultural and Veterinary Chemicals Code Regs 1994.

Medicated premix
Refer to the Agricultural and Veterinary Chemicals Code Regs 1994.

Medicated stock feed
Refer to the Agricultural and Veterinary Chemicals Code Regs 1994.

Non-active constituent(s) (excipient(s))
Any ingredient other than an active constituent which is part of a formulated product. Non-active constituents are added at the time of manufacture for various reasons, e.g. to improve formulation characteristics such as stability, solubility and spreadability. They do not contribute to the biological effect of the product.

Pesticide
Veterinary chemical products used externally on animals for preventing, destroying, repelling, attracting, inhibiting or controlling pests are termed ‘pesticides’ in some jurisdictions.

Poison
See scheduled substance.

Poisons schedules
The schedules accompanying the States and Territories Poisons Acts listing the various poisons in categories which are based on the recommendations of the SUSDP. Agricultural and veterinary chemical products generally fall into one of the following categories:

Schedule 4 - Prescription Animal Remedy Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe (medical, dental or veterinary) and should be available on medical, dental or veterinary prescription.

Schedule 5 - Caution Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.

Schedule 6 - Poison Substances with a moderate potential for causing harm, the extent of which can be reduce through the use of distinctive packaging with strong warning and safety directions on the label.

Schedule 7 - Dangerous Poison Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.

Schedule 8 - Controlled Drug Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

Precautions
Includes general advisory statements related to incompatibility or interactions that occur when the product is simultaneously administered with another product, if the product influences laboratory test results or if the product affects the physiological status of the pregnant or lactating female and / or foetus or neonate or animals with an existing condition or illness.

Premix
Refer to the Agricultural and Veterinary Chemicals Code Regs 1994.

Primary pack
The pack in which a poison/veterinary chemical product and its immediate container or measure pack are presented for sale or supply.

Product
A formulation containing one or more active constituent(s), and possibly non-active constituents(s), which is intended for application, with or without dilution prior to use, and which is labelled with directions for use.

Relevant scientific argument
The APVMA defines relevant scientific argument as:

• relevant:
  • related to the active constituent and/or product
  • related to the claims and use patterns
• scientific argument includes discussion based on:
  • accepted scientific principles
  • data published in peer reviewed journals
  • relevant texts
  • relevant case studies
  • relevant clinical studies

Restraint
A label statement outlining the situations in which the use of a product has an absolute limitation or restriction (related to residues, antibiotic resistance or environmental issues) that is not stated in the claim. Restraints are legally enforceable by State or Commonwealth jurisdiction.

Safety directions
Statements included on product labels which specify hazards, precautions and techniques for handling, mixing and using the product safely. Safety directions include general warnings, specific precautions and protective equipment relating to the safety of the operator/user, but not warnings or precautions relating to flammability, spillage, container disposal, or withholding periods.

Scheduled substance (poison)
A chemical listed in the schedules in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) published by the. National Drugs and Poisons Schedule Committee. See Poisons schedule also.

Signal word(s)
The words required by the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), published by the National Drugs and Poisons Schedule Committee, to appear at the top of the main panel of a label.

Solvent
A liquid which will dissolve one or more substances to form a solution.

Stockfood
Refer to the Agricultural and Veterinary Chemicals Code Regs 1994.

Substance
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Therapeutic pet food diet
A pet food that is to be used, or intended to be used, under veterinary supervision, and/or has been formulated or is represented to provide a beneficial component in the prevention, cure, treatment or management of, or recovery from, a specific disease or condition, as meets the definition of a veterinary chemical product.

Therapeutic use
The use of a product in or in connection with the preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in animals; influencing, inhibiting or modifying a physiological process in animals; or testing the susceptibility of animals to a disease or ailment as outlined in the veterinary chemical product definition (see below).

Topical use
Application of a poison/veterinary chemical product for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.

Transdermal use
Application of a veterinary chemical product to the skin primarily for systemic effect.

Veterinary chemical product
Refer to the Agricultural and Veterinary Chemicals Code Act 1994.

Warning statements
See safety directions.

Withholding period
The minimum recommended period that should elapse between the last treatment of an animal with a veterinary chemical product or the last exposure of an animal to an agricultural chemical as a result of grazing a treated crop and the slaughtering thereof of animals, or collection of milk and eggs from the animal for human consumption. It is part of the directions for use within the concepts of Good Agricultural Practice (GAP) and Good Practice in the Use of Veterinary Drugs (GPVD) in the use of agricultural and veterinary chemical products.

APPENDIX 1:   LABELLING REQUIREMENTS FOR INJECTABLE PRODUCTS

In addition to the standard labelling requirements (refer to Chapter 2 - Information Required on Labels), labels on injectable products must carry the following information (as applicable).

General Directions For Intravenous Injections

1. For all products (excluding those in Schedule 4 and Schedule 8) that are intended for intravenous administration or any other products as directed by the APVMA, the following statement must appear immediately below the Directions for Use heading but separate from the restraints and dosage and administration. Irrespective of the size of the pack, the following statement should be placed on the main panel of the label. The statement should appear in bold-faced sanserif letters as shown.

FOR USE ONLY BY OR UNDER the direction of, a registered veterinary surgeon.

2. Calcium borogluconate and other metabolic disease remedies do not require the above statement. However, the following statement must appear on the label. The statement should appear in bold-faced sanserif letters in sentence case.

Use of this product intravenously may be hazardous to the animal and advice from a registered veterinary surgeon should be sought.

General Directions For Subcutaneous Injections

3. General directions for subcutaneous injections are not required for the following products:

• vaccines used only by veterinarians
• veterinary Schedule 4 or Schedule 8 products;
• products intended for use on horses and companion animals;
• hormonal growth promotants and testosterone implants for sheep.

4. For products other than those stated above i.e. products for open sale intended for subcutaneous administration to food-producing animals, the following directions are required. These directions should appear conspicuously on the labelling and may be placed on a leaflet or on the label proper.

Caution: avoid carcass damage (bold-faced sanserif letters sentence case)

1. Sterilise all injection apparatus by boiling (or equivalent) before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible avoid injection of animals during wet weather or under dusty conditions.
6. This product should be injected only under the skin.
7. If possible inject high on the neck behind the ear.

5. Points to note

• These directions are not appropriate for calcium borogluconate and other metabolic disease remedies or for other injections of relatively large volume. For these products, items 5 and 7 should be omitted. Item 4 may also be omitted. For Poultry, items 5 and 7 may not be appropriate and can be omitted.
• In the case of a very small single-pack this direction should be presented in the form of a securely attached tag. In the case of a pack containing a number of small disposable syringes or collapsible tubes, the direction may be shown on the outer pack only.

General Directions For Intramuscular Injections

6. General directions for intramuscular injections are not required for Schedule 4 and Schedule 8 products.
7. For products other than those stated above i.e. products for open sale and intended for intramuscular administration to food-producing animals (including all vitamin injections for food-producing animals), the following directions are required. These directions should appear conspicuously on the labelling and may be placed on a leaflet or on the label proper.
   
   Caution: avoid carcass damage (bold-faced sanserif letters sentence case)
   1. 1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
   2. 2. Maintain cleanliness at all times.
   3. 3. Keep needles sharp and clean. Replace frequently.
   4. 4. Use needles of appropriate gauge and length.
   5. 5. As far as possible avoid injection of animals during wet weather or under dusty conditions.
   6. 6. This product should be injected only into muscle tissue.
   7. 7. If possible inject into muscle tissue on side of neck.
8. Points to note

• These directions may require modification in the case of injectable iron compounds for preventing piglet anaemia because of insufficient bulk of cervical muscle in newborn piglets. It is suggested that item 7 be replaced by ‘Injections may be made into the muscles of the hind leg’. A further statement is required on these products unless contrary evidence is p