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CONSULTATION DOCUMENT
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THERAPEUTIC GOODS ACT 1989
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THERAPEUTIC GOODS ORDER NO. 79
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Standard for the labelling of medicines
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I, John Skerritt, delegate of the Minister for Health for the purposes of section 10 of the
Therapeutic Goods Act 1989 and acting under that section, having consulted with the
Therapeutic Goods Committee in accordance with subsection 10(4) of that Act, HEREBY:
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(1)
Other than for the purposes of section 4(3), REVOKE, on and from <<1 January 2018 tbc>>, Therapeutic Goods Order No. 69 General requirements for labels for medicines
made on 27th August 2001, and as amended; and
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(2)
DETERMINE that the matters specified in this Order constitute a standard for medicines.
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<<Q4 2014 – tbc>>
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Dated
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[DRAFT ONLY - NOT FOR SIGNATURE]
John Skerritt
Delegate of the Minister for Health
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Page 1 of 42
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CONTENTS
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INTRODUCTION ........................................................................................................ 3
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1
NAME OF ORDER ............................................................................................. 4
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COMMENCEMENT ............................................................................................ 4
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APPLICATION - THERAPEUTIC GOODS TO WHICH ORDER APPLIES ....... 4
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TRANSITION ARRANGEMENTS ...................................................................... 5
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5 EXEMPTIONS – MEDICINES OR PACKAGING TO WHICH THIS ORDER DOES
NOT APPLY ............................................................................................................... 5
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INTERPRETATION ............................................................................................ 6
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GENERAL REQUIREMENTS, INCLUDING LABEL PRESENTATION .......... 12
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INFORMATION TO BE INCLUDED ON THE LABEL ..................................... 13
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INFORMATION TO BE INCLUDED ON THE MAIN LABEL ........................... 16
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QUALIFICATIONS AND SPECIAL REQUIREMENTS .................................... 18
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HOW INFORMATION IS TO BE EXPRESSED ............................................... 30
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SCHEDULE 1........................................................................................................... 36
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SUBSTANCES OR GROUPS OF SUBSTANCES PRESENT IN MEDICINES THAT
ARE REQUIRED TO BE DECLARED ON THE LABEL OF MEDICINES ............... 36
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SCHEDULE 2........................................................................................................... 41
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FORMAT OF MEDICINE INFORMATION PANEL .................................................. 41
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SCHEDULE 3........................................................................................................... 42
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SPECIFIED UNITS FOR ENZYMES ........................................................................ 42
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Page 2 of 42
Section Introduction
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Introduction
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(1)
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(2) The purpose of the label on a medicine is to provide information about the medicine
such as its identity, potency, content, storage, expiry date, dose, directions for use,
sponsor details and registration/listing status. Labels on medicines can also include
other information not required by this Order but which may be required by other
legislation or for commercial purposes such as the sponsor’s logo.
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(3)
The information included on a label contributes to the quality use of medicines.
Quality use of medicines means selecting management options wisely, choosing
suitable medicines if a medicine is considered necessary, and using those medicines
safely and effectively.
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(4)
The requirements set out in this Order are consistent with the National Medicines
Policy which aims to meet medication and related service needs, so that both optimal
health outcomes and economic objectives are achieved. The four central objectives
of the policy are:
This Order sets out what kinds of information are required to be included on the
label of a medicine and in what circumstances.
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(a)
timely access to the medicines that Australians need, at a cost individuals and
the community can afford;
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(b)
medicines meeting appropriate standards of quality, safety and efficacy;
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(c)
quality use of medicines; and
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(d)
maintaining a responsible and viable medicines industry.
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(4)
This Order also sets out general requirements for the labelling of medicines. The
purpose of the Order is to facilitate the quality use of medicines by consumers and
health professionals by ensuring the appropriate labelling of medicines.
Consideration of the following objectives in designing labels, and assessing and
determining compliance with the requirements of this Order, will assist in achieving
that purpose:
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
minimising the risk of prescribing, dispensing and self selection errors;
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
enhancing consumer safety;
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
avoiding consumer confusion and the inappropriate use of medicines
(including misuse, over-use, and under-use);
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
assisting the appropriate selection of a medicine;
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assisting the safe and effective use of a medicine;
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optimising identification and usability of necessary information;
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improving consumers’ ability to solve problems related to medicines, such as
managing multiple medicines; and
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
where relevant, ensuring consumers are aware of where to go for further
information about their medicine.
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(5)
Guidelines for medicine labelling are available on the Therapeutic Goods
Administration website (http://www.tga.gov.au) to assist sponsors in the design of
labels for medicines.
Page 3 of 42
Section 1
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(6)
Name of Order
Under the Act:
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
whether a medicine conforms to a standard applicable to the medicine is a
matter the Secretary must take into account in deciding whether to register the
medicine on the Register
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
an applicant for the listing of a medicine must certify that the medicine
conforms to every standard applicable to the medicine
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
failure to conform to a standard applicable to a medicine is grounds for the
Secretary to suspend or cancel the registration or listing of the medicine
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
failure to conform to a standard applicable to a medicine is grounds for the
Secretary to recall the medicine
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it is an offence to supply medicines in Australia that do not comply with a
standard applicable to the medicine relating to labelling or packaging and
civil penalties may be payable in relation to such supply
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whether the presentation of a medicine is acceptable is a matter the Secretary
must take into account in deciding whether a medicine can be registered –
‘presentation’ means the way in which the medicine is presented for supply
and includes matters relating to the labelling and packaging of the medicine.
Subject to specified notice requirements, the Secretary may decide to suspend
or cancel the registration of a medicine, if it appears to the Secretary that the
presentation of the medicine is not acceptable
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
an applicant for the listing of a medicine must certify that the presentation of
the medicine is not unacceptable. Unacceptable presentation is a ground for
suspension or cancellation of the listing of a medicine.
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
registered or listed medicines that have been supplied may be subject to
compulsory recovery requirements if:
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(a) in the case of a registered medicines, it appears to the Secretary that the
presentation of the medicine is not acceptable; and
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(b) in the case of listed medicines, it appears to the Secretary that the
presentation of the medicine is unacceptable.
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(7)
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Name of Order
This Order is to be known as the Therapeutic Goods Order No. 79 - Standard for the
labelling of medicines.
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Commencement
This Order commences on <<1 January 2015 – tbc >>.
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To avoid doubt, this section is not part of the Order.
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Application - Therapeutic goods to which Order applies
Subject to sections 4 and 5, this Order applies to medicines supplied or for supply in
Australia.
Page 4 of 42
Section 4
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Transition arrangements
Transition arrangements
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(1)
On or before <<31 December 2017 – tbc >>each medicine to which this Order
applies must comply with either:
(a) the requirements specified in this Order, or
(b) the requirements specified in Therapeutic Goods Order No 69 General
requirements for labels for medicines.
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(2)
On and from <<1 January 2018 – tbc>> each medicine to which this Order applies
must comply with the requirements specified in this Order.
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(3)
Notwithstanding (1) and (2), medicines imported into or manufactured in Australia
before <<1 January 2018 – tbc>> but supplied by a person other than the sponsor
after that date must comply with Therapeutic Goods Order No 69 General
requirements for labels for medicines (TGO 69), if at the time of their release for
supply they complied with TGO 69 by reason of (1) above.
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Exemptions – Medicines or Packaging to which this Order does not
apply
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(1)
This Order does not apply to a medicine that is:
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(a)
intended for use in the treatment of another person in accordance with an
approval set out in paragraph 19(1)(a) of the Act; or
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(b)
intended for life-threatening cases consistent with the requirements set out in
regulation 12A of the Regulations; or
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(c)
the subject of an authorisation granted under subsection 19(5) of the Act and
its use is consistent with the requirements set out in regulation 12B of the
Regulations; or
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(d)
exempted from the operation of Division 2 of Part 3-2 of the Act because of an
exemption made by the Minister under section 18A of the Act in relation to
that medicine; or
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(e)
the subject of an approval under section 19A of the Act; or
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(f)
intended for use solely for experimental purposes in humans in accordance
with an approval set out in paragraph 19(1)(b) of the Act or consistent with the
requirements set out in Item 3 of Schedule 5A of the Regulations; or
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(g)
a starting material used in the manufacture of a medicine, except when prepackaged for supply for other therapeutic purposes or formulated as a dosage
form; or
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(h)
not at its final stage of manufacture; or
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(i)
imported for use in the treatment of the importer or the importer’s immediate
family as set out in Item 1 of Schedule 5 of the Regulations; or
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(j)
a medical gas; or
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(k)
an export only medicine as defined in the Act; or
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(l)
made up or compounded extemporaneously by a pharmacist, or a person in the
course of his or her employment by a pharmacist and under the direct personal
Page 5 of 42
Section 6
Interpretation
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supervision of that pharmacist, in accordance with the individual prescription
of a health professional authorised under a law of a State or Territory to
prescribe; or
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(m) made up or compounded extemporaneously, for a specific or individual case,
by a pharmacist in the lawful practice of his or her profession; or
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(n)
supplied, in the course of treating a patient, by a health professional in the
lawful practice of his or her profession, unless it is a medicine in a starter
pack; or
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(o)
made up or compounded extemporaneously, for a specific and individual case,
by a complementary healthcare practitioner in the lawful practice of his or
her profession; or
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(p)
of a kind described in paragraph (a) or (b) of the entry ‘HUMAN BLOOD
PRODUCTS’ in Appendix A of the Poisons Standard.
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(2)
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The requirements of this Order do not apply to a transparent covering that encloses
or wraps the container or primary pack containing a medicine and where the
information which is required to be set out on the label of the container or the
primary pack is clearly visible through that transparent covering.
Interpretation
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In this Order:
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Act means the Therapeutic Goods Act 1989;
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active ingredient means a therapeutically active component in a medicine’s final
formulation that is responsible for its physiological or pharmacological action;
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adjuvant means an ingredient which, when administered with an antigen, modifies
the immune response to that antigen;
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antimicrobial preservative means an ingredient added to a medicine to inhibit the
growth of micro-organisms in the medicine;
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approved product details, in relation to a medicine, means details in relation to the
medicine as approved under section 25 of the Act for the registration of the
medicine;
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Australian Approved Names List has the same meaning as in the Regulations;
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batch number means a number, or a combination of numerals, symbols or letters,
which is given by a manufacturer to a batch of medicine, to uniquely identify that
batch and from which it is possible to trace that batch through all stages of
manufacture and distribution;
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batch number prefix means the prefix which precedes the batch number and clearly
indicates that the number is the batch number. The format must be in the form of
the following: BATCH NUMBER’, ‘BATCH NO.’, ‘BATCH’, ‘B’, ‘(B)’, B/N’,
‘LOT NUMBER’, ‘LOT NO.’, or ‘LOT’, or words or symbols to this effect,
including a mixture of lower and upper case letters;
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biological medicine means a medicine:
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(a)
Page 6 of 42
that is a peptide, protein or polysaccharide based, but is not an antibiotic; and
Section 6
Interpretation
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(b)
that is derived from biological sources; and
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(c)
that is required to be entered in the Register as registered goods: and
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(d)
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calendar pack means a pack containing individual dosage units that is labelled with
day/date markings to specify the sequence in which the dosage units in the pack must
be used in order to achieve the intended therapeutic activity;
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capacity means the volume of the empty container;
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Certificate of Listing, in relation to a medicine, means the certificate given to the
applicant for listing of the medicine under subsection 26A(9) of the Act in relation
to that medicine;
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Certificate of Registration, in relation to a medicine, means the certificate given to
the applicant for registration of a medicine under subsection 25AB(4) of the Act in
relation to that medicine;
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complementary healthcare practitioner means a person described in paragraph
42AA(1)(c) of the Act;
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composite pack has the same meaning as in the Act;
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concentrated solution for injection means a sterile liquid which must be diluted with
another sterile liquid in order to prepare an injection;
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container has the same meaning as in the Act;
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delivered dose means, in relation to:
(a) pressurised metered dose preparations for inhalation - the dose delivered from
the inhaler to the patient in a single actuation or delivery; and
(b) powders for inhalation - the dose delivered from the inhaler in a single
delivery;
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dial dispenser pack means a container that has the following characteristics:
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(a)
each of the dosage units is located in individual pockets preformed in a circular
rigid tray;
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(b)
a close-fitting, rotatable, transparent lid which can only be rotated in one
direction is located over the tray; and
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(c)
the individual dosage units can be dispensed by detaching a predefined portion
of the lid or tray, and rotating the lid to the appropriate position;
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directions for use has the same meaning as in the Act;
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diluent means a liquid used for reconstitution or dilution;
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is included in the list in Part 1 of Schedule 10 of the Regulations, except Items
14 and 15 under that Part,
but does not include a ‘biological’ within the meaning of section 32A of the Act;
durable, in relation to a label, means that the label will not before the expiry date,
under normal storage conditions deteriorate to the extent of becoming illegible, or
become detached from the container, packaging or pack, due to the influence of any
one or more of the following:
(a) light;
(b) atmospheric humidity or dryness;
Page 7 of 42
Section 6
Interpretation
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(c)
(d)
(e)
normal atmospheric temperatures;
recommended storage temperatures;
the contents of the container, packaging or pack;
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excipient, in relation to a medicine, means an ingredient of the medicine other than
the active ingredient;
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expiry date, in relation to a product, means the date (month and year) after which the
product should not be used;
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expiry date prefix means a prefix which precedes the expiry date which has the
following characteristics:
(a)
clearly indicates that the information following the prefix is the expiry date;
(b)
is in the following form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP.
DATE', or 'EXP' or words to this effect, including a mixture of lower and upper
case letters;
(c)
is not in the following form: 'Best by' or ‘Best before’ or ‘Use by’ or ‘Use
before’ or words to this effect.
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external, in relation to the use of a medicine, means application in the ears, eyes or
nose or to a body surface other than in the mouth, rectum, vagina, urethra or other
body orifice;
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health professional includes the following:
(a) a health practitioner of any kind registered under a law of a State or Territory
that provides for the registration of health practitioners of that kind; and
(b) a biomedical engineer, prosthetist or rehabilitation engineer;
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herbal material means a plant or part of a plant (defined by its botanical scientific
name according to the binominal nomenclature system, including author, and the
plant part), whether fresh or dried, that is whole, fragmented, cut or ground;
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herbal preparation means an ingredient that is the result of the processing of a
herbal material;
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homoeopathic medicine means a medicine that:
(a) contains one or more homoeopathic preparations; and
(b) may contain excipients necessary for presentation of the medicine in the final
dosage form.
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homoeopathic potency means the dilution factor of a homoeopathic preparation,
expressed as:
(a) ‘nX’ where each dilution is a decimal or ten-fold dilution and 'n' is the number
of dilutions such that the total dilution is 10n; or
(b) ‘nC’ where each dilution is a centesimal or hundred-fold dilution and 'n' is the
number of dilutions such that the total dilution is 100n; or
(c) ‘nLM’ or ‘LMn’ where, from a 3C starting dilution, each subsequent dilution is
a fifty millesimal or fifty thousand fold dilution and 'n' is the number of
dilutions such that the total dilution is 50,000n.
Note: Where 1000 centesimal dilutions are performed, the potency is expressed as nM;
that is, 1M potency represents a 1,000C dilution, 2M a 2,000C dilution, etc
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Section 6
Interpretation
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homoeopathic preparation has the same meaning as in the Regulations.
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hypertonic, in relation to the tonicity of large volume injections, means an injection
with an osmolality of more than 350 milliosmoles per kilogram of solvent, as
determined by the osmotic pressure;
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hypotonic, in relation to the tonicity of large volume injections, means an injection
with an osmolality of less than 250 milliosmoles per kilogram of solvent, as
determined by the osmotic pressure;
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intermediate packaging means a level of packaging which, if it exists, encloses one
or more containers and is itself enclosed in a primary pack;
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isotonic, in relation to the tonicity of large volume injections, means an injection
with an osmolality within the range 250 milliosmoles to 350 milliosmoles per
kilogram of solvent, as determined by the osmotic pressure;
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label means a display of printed information upon, or affixed to, the container, any
intermediate packaging and any primary pack containing the medicine;
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listed goods has the same meaning as in the Act;
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machine readable code means a code that:
(a) encodes the Global Trade Item Number (GTIN) for the medicine as allocated
under the GS1 System; and
(b) identifies different product variants and differentiates between different
strengths, pack sizes and dose forms;
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Note: The machine readable code may also include additional information such as batch
number and expiry date details. There is no specified format for the machine readable code.
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main label means:
(a) where there are two or more labels or two or more portions of a single label that label or portion of the label where the name of the medicine is more or
most conspicuously shown; or
(b) where the name of the medicine is equally conspicuous on two or more labels
or portions of a label – each label or portion;
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medical gas means a gas or a combination of gases presented for treating or
preventing disease or administered to humans with a view to making a medical
diagnosis or for the purpose of restoring, correcting or modifying physiological
functions in humans;
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medicine has the same meaning as in the Act;
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medicine kits has the same meaning as described in Item 12 of Part 1 of Schedule 4
to the Regulations;
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name and contact details in respect of the sponsor or supplier of a medicine means:
(a) the name of the Australian sponsor or supplier of the medicine; and
(b) sufficient information about the sponsor or supplier, whether by reason of the
inclusion of the sponsor’s or supplier’s street address of its registered place of
business in Australia (not being a post office address), an email address or a
telephone number, to allow it to be identified so as to facilitate public contact
on matters of complaint, use or general enquiry;
Page 9 of 42
Section 6
Interpretation
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name of an active ingredient means:
(a) the name of the active ingredient that is accepted for inclusion in the
Australian Approved Names List; or
(b) where the ingredient is a homoeopathic preparation:
(i) either the name of the active ingredient, or the substance from which the
dilution was prepared, that is accepted for inclusion in the Australian
Approved Names List, together with a statement of the homoeopathic
potency; or
(ii) until such time as a name is accepted for inclusion in the Australian
Approved Names List, a traditional homoeopathic name in full or as
traditionally abbreviated with a statement of the homoeopathic potency;
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name of an excipient means the name of the excipient that is accepted for inclusion
in the Australian Approved Names List;
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name of the dosage form means:
(a) in relation to a medicine that is intended to be, or is, a listed goods or
registered goods, the name of the dosage form as entered, or proposed to be
entered, in the Register in relation to the medicine; and
(b) in relation to a medicine that is not entered in the Register, the name of the
pharmaceutical form of the medicine;
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name of the medicine means the following:
(a) where the medicine is intended to be, or is, entered in the Register - the name
of the medicine intended to appear or appearing on the Certificate of
Registration or Certificate of Listing in relation to the medicine, not
including the following information:
(i) the name of the active ingredient (except where the name of the active
ingredient is intended by the supplier or the sponsor to be, or because of
the way it is represented, to form part of the name of the medicine);
(ii) the strength (except where numbers or words denoting strength are
included in that name to differentiate medicines, by strength);
(iii) the dosage form (except where this is integral to differentiate medicines
from other medicines);
(iv) container details;
(v) the pack size;
(vi) ‘new formulation’ or representations to the same effect; and
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(vii) flavour descriptors (except where this is integral to differentiate
medicines from other medicines);
(viii) the name of the sponsor or supplier (or part thereof) (except where the
name is intended by the supplier or the sponsor to be, or because of the
way it is represented, to form part of the name of the medicine); and
(b) where the medicine is neither intended to be, nor is, entered in the Register:
(i) the registered trade mark for the medicine; or
(ii) a unique, invented, common or scientific name,
assigned to the medicine by the sponsor and appearing on the label;
Page 10 of 42
Section 6
Interpretation
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nominal volume means the volume of medicine that the container is specified by
the sponsor or supplier to contain;
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nominal weight means the mass of medicine which the container is specified by the
sponsor or supplier to contain;
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osmolality means the number of osmoles (usually expressed as milliosmoles or
mOsm) of the solute in a kilogram of water;
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pharmaceutical benefit has the same meaning as in the Regulations;
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Poisons Standard means the current Poisons Standard as defined in section 52A of
the Act;
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primary pack has the same meaning as in the Act;
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quantity of the medicine means:
(a) where the medicine consists of discrete dosage units, such as tablets or
capsules or sachet – the stated number of units in the container; or
(b) where the medicine is:
(i) a solid or semi-solid, other than a biological medicine or a medicine for
injection - the nominal weight of the solid or semi-solid in the
container;
(ii) a liquid, other than a biological medicine - the nominal volume of the
liquid in the container;
(iii) a pressurised metered-dose preparation or dry powder inhaler - the stated
number of deliverable doses in the container;
(iv) a non-pressurised metered dose preparation - the minimum number of
deliverable doses in the container;
(v) a solid biological medicine - the nominal weight, number of doses or
potency units in the container;
(vi) a liquid biological medicine - the nominal volume of liquid in the
container and
(A) the nominal weight, total number of doses or potency units in the
container, or
(B) the nominal weight, number of doses or potency units per unit
volume, and
(c) where the medicine is a medicine of any of the kinds referred to in paragraph
(b) and the medicine consists of a number of identical containers within the
primary pack – the number of containers (e.g. 5 x 10 mL vials);
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Register has the same meaning as in the Act;
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registered goods has the same meaning as in the Act;
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Regulations means the Therapeutic Goods Regulations 1990;
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Secretary has the same meaning as in the Act;
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small container means a container which has a capacity less than or equal to
25 millilitres that is not a very small container;
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solid ophthalmic medicine means a substance in a container to which a sterile
diluent is added to prepare eye drops;
Page 11 of 42
Section 7
General requirements, including label presentation
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sponsor has the same meaning as in the Act;
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standard has the same meaning as in the Act;
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standardisation means the process in which the content of a specific chemical
constituent(s) has been determined in a herbal material or herbal preparation.
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starter pack means:
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(a)
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Therapeutic Goods Advertising Code has the same meaning as in the Act;
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very small container means a container having a capacity less than or equal to
2.5 millilitres;
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warning statements means:
(a) any labelling requirements specified in the instrument made by the Minister
under subsection 3(5A) of the Act, as in force from time to time;
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(b)
(c)
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(b)
for medicines for which a pharmaceutical benefit is payable - a pack that
does not exceed one-third of the most commonly prescribed pharmaceutical
benefits quantity (the pharmaceutical benefits primary quantity); and
for other medicines - a pack that does not exceed one-third of the smallest trade
pack;
Note:
(d)
(e)
7
These requirements apply to all medicines other than those described in Part 1
of Schedule 10 to the Therapeutic Goods Regulations 1990
any warning statements specified in any standard that applies to the medicine;
any warning required by the Secretary to be included on the label as a
condition of registration or listing in relation to the medicine;
any warning statement specified in the Regulations that applies to the
medicine; and
any warning statements specified in the Poisons Standard.
General requirements, including label presentation
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(1)
The container, intermediate packaging (if any) and primary pack in which a
medicine is packed must each bear a label or labels that comply with the
requirements of this Order that are applicable in relation to that medicine.
439
(2)
The information required by this Order to be included on a label or labels must:
440
(a)
be clearly visible and not be obscured; and
441
(b)
be in the English language; and
442
(c)
be in durable and legible characters; and
443
444
(d)
unless otherwise specified, be displayed in text size of not less than the
equivalent of 6 point Arial; and
445
(e)
be in a colour or colours contrasting strongly with the background; and
446
(f)
unless otherwise specified, be in a metric unit of measurement only.
447
448
(3)
The label must be:
(a)
Page 12 of 42
durable; and
Section 8
449
450
451
452
453
454
455
(b)
456
457
458
(4)
Information to be included on the label
unless it is attached to a container (such as a blister or strip pack or sachet)
which individually encloses or seals dosage units in such a way that the
container must be cut or torn to access the dosage units, and the container is
enclosed in a primary pack that complies with the requirements of this Order in such a position on the container, packaging or pack that information
required by this Order to be included on the label is not damaged, defaced,
destroyed, or removed when the packaging is opened.
Other than for medicines intended to be, or that are, listed goods or registered
goods, the label must comply with advertising requirements, in particular, the
requirements set out in:
459
(a)
Part 5-1 of the Act or the regulations; and
460
(b)
the applicable provisions of the Therapeutic Goods Advertising Code,
461
462
463
464
465
466
467
unless specific exemptions or approvals in writing have been given by the relevant
delegate of the Secretary in relation to the medicine under the Act which have the
effect that the relevant requirement does not apply in relation to the label.
468
469
470
471
Note:
8
Registered goods and listed goods must comply with requirements relating to
advertising applicable under Part 5-1 of the Act or under the regulations and the
applicable provisions of the Therapeutic Goods Advertising Code: see
s.25(1)(1)(fa), s.26(1)(fa) and s.26A(2)(da) of the Act.
Information to be included on the label
(1)
Subject to the qualifications and requirements specified in sections 9 and 10 below,
the labelling on a container or on a primary pack for a medicine must include:
Note:
For intermediate packaging that is opaque, see (2) below.
472
(a)
the name of the medicine; and
473
(b)
the name(s) of all active ingredients in the medicine; and
474
(c)
the quantity or proportion of all active ingredients in the medicine; and
475
(d)
the name of the dosage form; and
476
(e)
the quantity of the medicine; and
477
(f)
the batch number of the medicine preceded by the batch number prefix; and
478
(g)
the expiry date of the medicine, preceded by the expiry date prefix; and
479
(h)
the storage conditions applicable to the medicine; and
480
481
482
483
484
485
(i)
the name and contact details of the sponsor or supplier of the medicine as at
the date of release for supply or, where there was a change in the name or
contact details of the sponsor or supplier, whether by reason of a change of
supplier or sponsor or otherwise, within the 12 months preceding that date, the
name and contact details of the sponsor or supplier immediately prior to that
change; and
486
(j)
where:
487
488
(i)
Page 13 of 42
a substance or substance within the group of substances referred to in
Column 1 of Schedule 1 to this Order is present in the medicine;
Section 8
Information to be included on the label
489
490
(ii)
the circumstances as set out in Column 2 of Schedule 1 exist in relation
to such a substance or no circumstances are set out in Column 2; and
491
492
(iii) the medicine is intended to be administered via any one or more of the
route(s) of administration referred to in Column 3 of Schedule 1,
493
then:
494
(iv) a statement:
495
496
(A) indicating that the medicine contains the substance expressed using
the Name stated in Column 4 of Schedule 1; and
497
498
499
500
501
502
503
(B)
504
505
506
where any of the circumstances and requirements set out in Column
2 of Schedule 1 exist in relation to the substance – a statement of
the kind referred to as a ‘requirement’ in that Column (if any)
except where the medicine contains a substance included in Schedule 4 or
Schedule 8 of the Poisons Standard or is a human blood product included in
Appendix A of the Poisons Standard and the information referred to in (iv) is
set out in a leaflet inserted in the primary pack of the medicine;
(k)
warning statements, where these are required in relation to a particular
medicine or in specified circumstances applying to a particular medicine such
as the following:
507
508
509
(i)
where the medicine is for external use the required statement is
‘Caution: Not to be Swallowed’, or ‘For External Use Only’, or words to
this effect;
510
(ii)
where:
511
512
513
514
515
516
517
518
519
520
521
(A) the medicine is for oral use; and
(B) the medicine does not contain a substance included in Schedule 4
or Schedule 8 of the Poisons Standard; and
(C) the medicine contains active ingredient(s) included in category
'B' (including 'B1', 'B2, 'B3') or category 'C' in the document titled
‘Prescribing medicines in pregnancy database’ published on the
TGA website as on the date of commencement of this Order; and
(D) the medicine is not subject to other specific warning statement(s)
relating to use during pregnancy,
the required statement is: ‘If pregnant or likely to become pregnant,
consult a pharmacist or a doctor before use’ or words to this effect;
522
(iii) where:
523
524
525
526
527
528
529
530
531
(A) the medicine is a registered goods for oral use; and
(B) the medicine does not contain a substance included in Schedule 4
or Schedule 8 of the Poisons Standard; and
(C) the medicine contains active ingredient(s) included in category
‘D’ in the document titled ‘Prescribing medicines in pregnancy
database’ published on the TGA website as at the date of
commencement of this Order; and
(D) the medicine is not subject to other specific warning
statements(s) relating to use during pregnancy,
Page 14 of 42
Section 8
the required statement is ‘Do not use this medicine if pregnant or likely
to become pregnant’ or words to this effect; and
532
533
534
Information to be included on the label
(l)
directions for use of the medicine except where:
535
536
537
(i)
the medicine contains a substance that is included in Schedule 4 or
Schedule 8 of the Poisons Standard, or is a human blood product
included in Appendix A of the Poisons Standard; or
538
539
540
(ii)
the dose of the medicine is usually determined for each individual patient
by a health professional authorised under a law of a State or Territory to
determine the dose; or
541
542
543
544
545
546
(iii) there is insufficient space on the label of the container or the primary
pack to include directions for use, and those directions for use are set
out in a leaflet inserted in the primary pack of the medicine, and a
statement is included on the label on the container or the primary pack,
as the case may be, that those directions are set out in the enclosed
leaflet; and
547
548
549
550
(m) if the medicine requires some preparation, such as dissolving, suspending,
diluting or reconstituting before use - instructions for its preparation and, where
relevant, a statement of the conditions of storage and the maximum period of
storage between preparation and use, except where:
551
552
(i)
there is insufficient space on the label of the container or the primary
pack to include this information; and
553
554
(ii)
this information is set out in a leaflet inserted in the primary pack of the
medicine; and
555
556
557
(iii) a statement is included on the label on the container or the primary
pack, as the case may be, that those instructions are set out in the
enclosed leaflet; and
558
559
(n)
a statement of the purpose or purposes for which it is intended that the
medicine be used, except where:
560
561
562
(i)
563
(ii) the medicine is:
564
565
566
567
568
569
the medicine contains a substance that is included in Schedule 4 or
Schedule 8 of the Poisons Standard, or is a human blood product
included in Appendix A of the Poisons Standard; or
(A)
(B)
Page 15 of 42
supplied solely to a complementary healthcare practitioner for
supply to a person after affixing by the practitioner of an
instruction label on the medicine following a consultation with that
person; and
the label of the medicine includes the words ‘For Practitioner
Dispensing Only’; and
Section 9
570
Information to be included on the main label
(o) if the medicine is:
571
572
573
(i)
an injection or infusion - the approved route(s) of administration, such as
'intravenous', 'intramuscular', or 'subcutaneous' or other phrase, word or
abbreviation denoting the approved route(s) of administration; or
574
575
576
577
(ii)
contained in an ampoule but is not an injection - a statement of the
approved route of administration for the medicine, such as ‘inhalation’,
‘For oral use only’ or other phrase, word or abbreviation denoting the
approved route(s) of administration; and
578
579
580
581
(p)
a machine readable code, if the medicine contains a substance that is
included in Schedule 4 or Schedule 8 of the Poisons Standard, or is a human
blood product included in Appendix A of the Poisons Standard, except where
the medicine is a starter pack;
582
583
584
585
586
(q)
a minimum space of 70 x 30 millimetres for the dispensing label, if the
medicine contains a substance that is included in Schedule 4 or Schedule 8 of
the Poisons Standard, or is a human blood product included in Appendix A of
the Poisons Standard, unless precluded by the dimensions of the primary
pack; and
587
588
(r)
where the medicine is packaged in a primary pack that is a carton, that name
of the medicine on at least three non-opposing sides of the carton.
589
590
(2)
If intermediate packaging (if any) is opaque, then the label on the intermediate
packaging must include:
591
(a)
the name of the medicine; and
592
(b)
the name(s) of all active ingredients in the medicine; and
593
(c)
the quantity or proportion of all active ingredients in the medicine; and
594
(d)
the batch number of the medicine preceded by the batch number prefix; and
595
(e)
the expiry date of the medicine preceded by the expiry date prefix; and
596
597
(f)
the name of the sponsor, or registered trademark that readily identifies the
sponsor or supplier of the medicine.
598
599
600
601
602
603
604
605
(3)
9
If the container is fully enclosed within a disposable delivery device which obscures
the label on the container from view, the labelling requirements on the label on the
container must also be applied on the delivery device and visible on the surface of
that device.
Information to be included on the main label
(1)
Subject to the qualifications and special requirements specified in this section and
section 10 of this Order, the information on the main label of the medicine must
include:
606
(a)
the name of the medicine; and
607
(b)
the name(s) of all active ingredients in the medicine; and
608
(c)
the quantity or proportion of all active ingredients in the medicine; and
609
(d)
the name of the dosage form; and
Page 16 of 42
Section 9
Information to be included on the main label
610
(e)
the quantity of the medicine; and
611
(f)
if the medicine is:
612
613
614
(i)
an injection or infusion - the approved route(s) of administration, such as
'intravenous', 'intramuscular', or 'subcutaneous' or other phrase, word or
abbreviation denoting the approved route(s) of administration; or
615
616
617
618
(ii)
contained in an ampoule but is not an injection - a statement of the
approved route of administration for the medicine, such as ‘inhalation’,
‘For oral use only’ or other phrase, word or abbreviation denoting the
approved route(s) of administration.
619
620
621
(2)
The name of the medicine on the main label must be presented in a continuous,
uninterrupted manner and not be broken up by additional information, logos,
background text or graphics.
622
623
(3)
The name of the medicine and the name(s) of active ingredient(s) must on the
main label:
624
625
626
(a)
appear as a cohesive unit by placing the name, and quantity, of each active
ingredient together on separate lines of text immediately below the name of
the medicine; and
627
628
629
(b)
not be separated by any text or graphics, except where additional information is
required by paragraph 11(2)(j) or in relation to medicines contained in a
composite pack or a medicine kit.
630
631
(4)
All text required by this Order to be on the main label must be oriented in the same
direction.
632
633
634
635
636
(5)
Subject to subsection (7), the active ingredient(s) and the quantity or proportion of
active ingredient(s) must be identifiable in relation to the other material on the label
(whether required under the Order to be included or otherwise) including through the
choice of type size, font type or colour of the name of the active ingredient(s) and
quantity or proportion of active ingredient(s) and of the other material.
637
(6) If the medicine is intended to be, or is, listed goods:
638
639
640
641
(a)
if the medicine is a sunscreen preparation - the name of every active
ingredient, together with the quantity or proportion of every active
ingredient, and the name of the dosage form, may appear on a side panel or
side label or on a rear panel or rear label; or
642
643
644
645
(b)
if there are four or more active ingredients in the medicine - the name of
every active ingredient, together with the quantity or proportion of every
active ingredient, may appear on a side panel or side label or on a rear panel
or rear label.
646
(7)
Subject to (8), if the medicine is intended to be, or is, registered goods:
647
648
649
(a)
the name of the active ingredient(s) and the quantity or proportion of active
ingredient(s) must be displayed in a text size of not less than the equivalent of
15 point Arial in any sans serif font; and
650
651
652
(b)
if the medicine is a solution for injection, powder for injection or
concentrated solution for injection and the route of administration is only for
infusion – then in addition to the requirement set out in paragraph (a), the
Page 17 of 42
Section 10
Qualifications and special requirements
words ‘for infusion’ must be displayed adjacent to the name of the dosage
form.
653
654
655
656
(8)
If the medicine is intended to be, or is, registered goods and there are four or more
active ingredients and:
657
658
659
660
661
(a)
subsection 10(20) does not apply - the names of every active ingredient,
together with the quantity or proportion of every active ingredient, may be
included on a side panel or side label or on a rear panel or rear label, displayed
in a text size of not less than the equivalent of 12 point Arial in any sans serif
font; or
662
663
664
(b)
10(20) applies - the names of every active ingredients, together with the
quantity or proportion of every active ingredient, need not be displayed on the
main label.
665
666
10
Qualifications and special requirements
(1)
Preparations for ophthalmic use
667
668
669
In addition to the requirements of sections 8 and 9 above, if a medicine is a
preparation for ophthalmic use, the label on the container and on the primary pack
or, where subsections 10(14) or 10(15) applies, on the primary pack, must include:
670
(a)
the name of any antimicrobial preservative in the medicine;
671
672
673
(b)
if the medicine, other than an ophthalmic ointment, does not contain an
antimicrobial preservative - the statement ‘Contains no antimicrobial
preservative. Use once only and discard residue’ or words to that effect;
674
675
676
677
(c)
if the medicine is for multidose use - a statement to the effect that “the
medicine should not be used more than four weeks”, or such shorter period as
specified in the approved product details in relation to the medicine, after the
container is first opened;
678
679
680
681
682
(d)
if the medicine consists of a solid ophthalmic medicine for preparing eye
drops for multidose use - a statement to the effect that “the medicine when
prepared should not be used more than four weeks”, or such shorter period as
specified in the approved product details in relation to the medicine, after the
container is first opened.
683
684
(e)
if the medicine consists of a solid ophthalmic medicine for preparing eye
drops for multidose use - the words ‘for eye drops’.
685
686
687
688
689
690
(2)
Injections with nominal volume greater than 100 millilitres
(a)
691
692
693
694
If a medicine is an injection having a nominal volume greater than
100 millilitres, or is a concentrated solution for injection which when made
up has a nominal volume of greater than 100 millilitres, the label on the
container and on the primary pack must comply with sections 8 and 9 above,
and subsection 10(8) if applicable, subject to the following:
(i)
Page 18 of 42
where there are more than three active ingredients belonging to the same
class of substances, such as amino acids, carbohydrates or electrolytes in
the medicine – the information on the label must include the class of
substances and the name of the dosage form;
Section 10
Qualifications and special requirements
695
696
697
698
699
(ii)
700
701
702
703
704
705
(iii) where the medicine contains an active ingredient that is not intended for
electrolyte replacement or nutritional therapy and is not intended for use
as a radio-contrast agent or as a plasma volume expander or replacement
- the information on the label must include a statement of the proportion
of that active ingredient expressed in terms of weight (or potency, if
appropriate) in the nominal volume of injection in the container.
706
707
708
709
(b)
where the medicine is intended for electrolyte replacement or nutritional
therapy or is intended for use as a radio-contrast agent or as a plasma
volume expander or replacement - the information on the label must
include a statement of the proportions of dissolved, emulsified or
suspended active ingredients in the medicine in terms of percentages;
The label on the container and on the primary pack of a medicine that is an
injection having a nominal volume greater than 100 millilitres, or is a
concentrated solution for injection which when made up has a nominal
volume of greater than 100 millilitres, must also include:
710
711
(i)
the name and quantity of each excipient in the nominal volume of
injection in the container; and
712
713
714
(ii)
where one or more active ingredients are amino acids and/or protein - a
statement giving the total amount of nitrogen, in grams, in the nominal
volume of injection in the container; and
715
716
717
(iii) where the medicine is intended for use as an energy source - a statement
of the energy equivalent, in kilojoules, of the nominal volume of
injection in the container; and
718
719
720
(iv) where the medicine is intended for use as a radio-contrast agent - a
statement of the equivalent amount of iodine in terms of milligrams of
iodine per millilitre; and
721
(v)
722
723
(vi) a statement specifying whether the injection is hypotonic or hypertonic
or isotonic; and
724
(vii) the pH range of the injection; and
725
726
(viii) the statement ‘Use in one patient on one occasion only. Contains no
antimicrobial preservative’ or words to that effect.
727
(3)
the osmolality; and
Injections with nominal volume of 100 millilitres or less
728
729
730
731
732
Except where subsection 10(4) or 10 (5) below applies, if a medicine is an injection
that has a nominal volume of 100 millilitres or less, or is a concentrated solution
for injection which when made up has a nominal volume of 100 millilitres or less,
then in addition to the requirements of sections 8 and 9 above, and subsection 10(8)
if applicable, the label on the container and on the primary pack must include:
733
(a)
the name and quantity of each excipient in the medicine, expressed:
734
735
(i)
for single dose injections - as the quantity of that excipient in the
nominal volume of injection in the container;
736
737
(ii)
for a powder or a concentrated solution for injection - as the quantity
of that excipient in the container;
Page 19 of 42
Section 10
738
739
740
Qualifications and special requirements
(iii) where the injection is intended for multidose use - as the quantity of that
excipient in one millilitre of the injection or as the quantity in a suitable
dose volume where the nominal volume is less than one millilitre; and
741
742
743
744
(b)
where the medicine is supplied in a container with potential for multidose use,
such as a vial or pre-filled syringe, and an antimicrobial preservative is not
included in the medicine - the statements ‘Use in one patient on one occasion
only. Contains no antimicrobial preservative’ or words to that effect; and
745
746
(c)
where the medicine is a concentrated solution for injection or is a powder
for injection administered by infusion:
747
(i)
a direction not to administer the solution undiluted; and
748
749
750
751
(ii)
a direction to dilute the solution with the specified diluent by the
appropriate factor or to the appropriate volume before use, or, the
statement ‘see Product Information for dilution instructions’ or words to
that effect; and
752
753
754
755
(d)
(4)
where the medicine is an injection containing a radio-contrast agent - a
statement of the equivalent amount of iodine in terms of milligrams of iodine
per millilitre.
Injections with container capacity of 25 millilitres or less
756
Except where subsection 10(5) applies, if a medicine is an injection that:
757
(a)
has a container capacity of 25 millilitres or less; and
758
759
(b)
the container is enclosed in a primary pack, the label of which complies with
the requirements of this Order,
760
761
762
then the label on the container must comply with sections 8 and 9 and subsection
10(3) and subsection 10(8) (if applicable) except if the label contains the following
information displayed in a text size of not less than the equivalent of 8 point Arial:
763
(c)
the name of the medicine; and
764
(d)
the name(s) of all active ingredients in the medicine;
765
766
and the following information displayed in a text size of not less than the equivalent
of 6 point Arial:
767
(e)
the quantity or proportion of all active ingredients in the medicine; and
768
(f)
the name of the dosage form; and
769
(g)
the quantity of the medicine; and
770
(h)
the batch number of the medicine preceded by the batch number prefix; and
771
(i)
the expiry date of the medicine preceded by the expiry date prefix; and
772
773
774
(j)
the name of the sponsor or supplier as it appears on the primary pack, or
registered trademark that readily identifies the sponsor or supplier of the
medicine; and
775
776
777
(k)
the approved route of administration for the medicine, such as ‘intravenous’,
‘intramuscular’ or ‘subcutaneous’ or other phrase, word or abbreviation
denoting the approved route(s) of administration; and
Page 20 of 42
Section 10
Qualifications and special requirements
where the medicine must be diluted before use - the direction ‘Dilute before
use’; and
778
779
(l)
780
781
(m) if the injection is a biological medicine - the name of any adjuvants in the
medicine; and
782
783
784
785
(n)
786
(5)
where the medicine is supplied in a container with potential for multidose use,
such as a vial or pre-filled syringe, and an antimicrobial preservative is not
included in the medicine - the statements ‘Use in one patient on one occasion
only. Contains no antimicrobial preservative’ or words to that effect.
Injections with container capacity of 2.5 millilitres or less
787
If:
788
789
(a)
a medicine is an injection that has a container capacity of 2.5 millilitres or
less; and
790
791
(b)
the container is enclosed in a primary pack, the label of which complies with
the requirements of this Order;
792
793
794
795
796
then the label on the container must comply with sections 8 and 9 and subsection
10(3), and subsection 10(8) if applicable except if the label on the container
contains the name of the medicine displayed in a text size of not less than the
equivalent of 6 point Arial and the following information displayed in a text size of
not less than the equivalent of 4 point Arial:
797
(c)
the quantity of the medicine; and
798
(d)
the batch number of the medicine preceded by the batch number prefix; and
799
(e)
the expiry date of the medicine preceded by the expiry date prefix; and
800
801
802
(f)
the approved route of administration for the medicine, such as ‘intravenous’,
‘intramuscular’ or ‘subcutaneous’ or other phrase, word or abbreviation
denoting the approved route(s) of administration; and
803
804
(g)
where the medicine must be diluted before use - the direction ‘Dilute before
use’; and
805
806
807
808
809
810
811
812
(h)
where the medicine is supplied in a container with potential for multidose use,
such as a vial or pre-filled syringe, and an antimicrobial preservative is not
included in the medicine - the statement 'Single dose', or words to that effect,
and, where space permits, ‘Use in one patient on one occasion only. Contains
no antimicrobial preservative’ or words to that effect. If the container label size
does not allow the statement 'Use in one patient on one occasion only.
Contains no antimicrobial preservative.', this statement must appear on the
primary packaging; and
813
814
815
(i)
if the medicine contains only one active ingredient - the name of the active
ingredient and the quantity or proportion of the active ingredient in the
medicine, or suitable unambiguous abbreviation of the name and quantity; and
816
817
818
(j)
if the medicine is available in more than one strength and the name of the
medicine does not identify the strength - the quantity or proportion of each
active ingredient.
Page 21 of 42
Section 10
819
(6)
Qualifications and special requirements
Peritoneal dialysis solutions
820
821
822
The label on the container and on the primary pack of a medicine which is a
solution for use in peritoneal dialysis must, in addition to the requirements referred to
in sections 8 and 9, include:
823
824
825
(a)
the formulation of the solution expressed in grams per litre and in millimoles
per litre, including that if a concentrate for peritoneal dialysis solution the
formulation must include the formulation both before and after dilution; and
826
(b)
the calculated osmolarity expressed in milliosmoles per litre; and
827
(c)
the nominal volume of the solution in the container; and
828
829
(d)
a statement that the solution is free from bacterial endotoxins, or where
applicable, that it is apyrogenic; and
830
(e)
a statement that the solution is not to be used for intravenous infusion; and
831
832
(f)
a statement ‘Use in one patient on one occasion only. Contains no
antimicrobial preservative’ or words to that effect; and
833
834
(g)
if a concentrate, the statement ‘Dilute before use’ and the directions for
dilution (e.g. ‘See product information for dilution instructions’).
835
836
(7)
837
838
839
840
841
842
Preparations for use on skin and/or mucous membranes or by
inhalation, and metered nasal sprays
The label on a container and on a primary pack (if any) of a medicine which is a
preparation for use on skin and/or mucous membranes or is for inhalation or is a
metered nasal spray, but not including a medicine for ophthalmic use, must, in
addition to the requirements referred to in sections 8 and 9 above, include the name
of any antimicrobial preservative in the medicine.
(8)
Biological medicines
843
844
845
The label on a container and on a primary pack (if any) of a biological medicine
must, in addition to the requirements referred to in sections 8 and 9 above, and
subsections 10(2) and 10(3) if applicable, include:
846
847
(a)
the name and proportion of any antimicrobial preservative in the medicine;
and
848
(b)
the name of any adjuvants in the medicine; and
849
(c)
for vaccines produced in animal cells or cell cultures:
850
851
(i)
the name of the cell culture substrate or the name of the source animal,
and the name of the tissue used in the manufacture of the medicine; and
852
(ii)
the name of any residual antibiotic present in the medicine; and
853
854
(d)
Page 22 of 42
for antisera - the name of the animal in which the medicine has been prepared;
and
Section 10
Qualifications and special requirements
855
856
857
(e)
for monoclonal antibodies and recombinant products - the abbreviated name of
the cell culture substrate, placed immediately after the active ingredient name;
and
858
859
(f)
for other biological medicines - the name of the animal or organism from
which the medicine has been prepared.
860
(9)
861
862
863
864
865
866
867
868
Homoeopathic medicines
Where all the active ingredients in a medicine are homoeopathic preparations, the
main label on the container and the main label on the primary pack (if any) must,
in addition to the requirements referred to in sections 8 and 9 above, include a
statement to the effect that the medicine is a homoeopathic medicine in text size
that is not less than 50% of the text size of the name of the medicine and (in any
event) not less than the equivalent of 8 point Arial.
(10)
Formulations containing both homoeopathic preparations and nonhomoeopathic ingredients
869
870
871
872
Where a medicine contains active ingredients that are homoeopathic
preparations, and other active ingredients that are not homoeopathic
preparations, then, in addition to the requirements referred to in sections 8 and 9
above:
873
874
875
876
877
(a)
the main label on the container and the main label on the primary pack (if
any) must include a statement to the effect that the medicine contains
homoeopathic preparations in text size that is not less than 50% of the text
size of the name of the medicine and (in any event) not less than the
equivalent of 8 point Arial; and
878
879
880
881
882
883
(b)
the label on the container and the label on the primary pack (if any) must
differentiate ingredients that are homoeopathic preparations from those that
are not, such as by including the statement ‘contains homoeopathic
preparations of’ adjacent to the list of homoeopathic ingredients, or by
prefacing the name of the homoeopathic active ingredient with the term
‘homoeopathic’.
884
(11)
885
886
887
888
889
Sunscreen preparations
If the medicine is a sunscreen preparation and is enclosed in a container which has a
capacity of not more than 25 millilitres, then notwithstanding sections 8 and 9, the
information on the container (other than the sun protection factor) may be reduced
to a text size of not less than the equivalent of 4 point Arial.
(12)
Medicine kits
890
891
The label on a package that, together with medicines, constitute a medicine kit must
include the following information:
892
(a)
the name given to the kit; and
893
(b)
the name and contact details of the sponsor of the kit; and
894
(c)
the name of each of the medicines within the kit and its dosage form; and
Page 23 of 42
Section 10
Qualifications and special requirements
895
896
(d)
the name, and quantity or proportion, of all active ingredients in each of the
medicines within the kit; and
897
(e)
the quantity of each medicine within the kit; and
898
899
900
(f)
a statement of purpose for each medicine within the kit except where a
medicine contains a substance that is included in Schedule 4 or Schedule 8 of
the Poisons Standard; and
901
902
903
904
(g)
directions for use for each medicine within the kit or a statement directing
consumers to the directions for use on the label of each medicine within the
kit, except where the medicine contains a substance that is included in
Schedule 4 or Schedule 8 of the Poisons Standard; and
905
(h)
the batch number of the kit preceded by the batch number prefix; and
906
907
(i)
an expiry date for the kit, being the earliest expiry date of the medicines
within the kit, preceded by the expiry date prefix; and
908
909
(j)
any warning statements that relate to the any of the medicine within the kit;
and
910
911
(k)
storage conditions applicable to the kit, being the most restrictive of the storage
conditions for any of the medicines within the kit; and
912
913
(l)
the listing number given to the kit, set out on the label consistent with the
requirements specified in the Regulations.
914
915
916
917
Note:
(13)
The label on the container and on the primary pack (if any) of each
medicine within a medicine kit must comply with the requirements of
this Order.
Starter packs
918
919
920
921
Where a medicine contains a substance that is included in Schedule 4 or Schedule 8
of the Poisons Standard and is presented in a starter pack, in addition to the
requirements referred to in sections 8 and 9, the label on the container or primary
pack (if any) must include:
922
923
924
(a)
a space to accommodate the addition of at least the following dispensing
details: patient’s name, prescriber’s name and telephone number, directions
for use including dose, and date of supply; and
925
926
927
(b)
warnings required under State or Territory law to be applied at time of
dispensing, except where there is insufficient space, in which case the
information must be set out in a leaflet inserted in the primary pack; and
928
(c)
the statement ‘starter pack’ or words to that effect.
929
(14)
Small containers (not including injections)
930
If:
931
932
(a)
the medicine is enclosed in a small container (but is not a very small
container) and is not an injection; and
933
934
(b)
the container is enclosed in a primary pack, the label of which complies with
the requirements of this Order,
Page 24 of 42
Section 10
Qualifications and special requirements
935
936
937
938
then the label on the container must comply with sections 8 and 9 and subsections
10(1) and 10(8) (if applicable), except if there is set out on the label of the container
the following information displayed in a text size of not less than the equivalent of 8
point Arial:
939
(c)
the name of the medicine; and
940
(d)
the name(s) of all active ingredients in the medicine,
941
942
and the following information displayed in a text size of not less than the equivalent
of 6 point Arial:
943
(e)
the quantity or proportion of all active ingredients in the medicine; and
944
(f)
the name of the dosage form; and
945
(g)
the quantity of the medicine; and
946
(h)
the batch number of the medicine preceded by the batch number prefix; and
947
(i)
the expiry date of the medicine preceded by the expiry date prefix; and
948
949
(j)
the name of the sponsor as it appears on the primary pack, or registered
trademark that readily identifies the sponsor or supplier of the medicine; and
950
951
952
953
(k)
if the medicine is contained in an ampoule - a statement of the approved route
of administration for the medicine, such as ‘inhalation’, ‘For oral use only’ or
other phrase, word or abbreviation denoting the approved route(s) of
administration of the medicine; and
954
(l)
if the medicine:
955
956
957
958
(i)
is an ophthalmic preparation for multidose use - a statement to the effect
that the medicine should not be used later than four weeks, or another
shorter period as specified in the approved product details in relation to
the medicine, after the container is first opened ; or
959
960
961
962
963
(ii)
consists of a solid ophthalmic medicine for preparing eye drops for
multidose use - a statement to the effect that the medicine when prepared
should not be used later than four weeks, or another shorter period as
specified in the approved product details in relation to the medicine,
after the container is first opened;
964
965
(m) if the medicine is a biological medicine - the name of any adjuvants in the
medicine; and
966
967
(n)
968
(15)
if the medicine is intended to be, or is, registered goods and there are four or
more active ingredients.
Very small containers (not including injections)
969
If:
970
(a)
the medicine is enclosed in a very small container but is not an injection; and
971
972
(b)
the container is enclosed in a primary pack, the label or which complies with
the requirements of this Order,
973
974
975
then the label on the container must comply with sections 8 and 9, and subsections
10(1) and 10(8) if applicable, except if the name of the medicine is set out on the
label of the container displayed in a text size of not less than the equivalent of 6
Page 25 of 42
Section 10
Qualifications and special requirements
976
977
point Arial, together with the following information displayed in a text size of not
less than the equivalent of 4 point Arial:
978
(c)
the quantity of the medicine; and
979
(d)
the batch number of the medicine preceded by the batch number prefix; and
980
(e)
the expiry date of the medicine preceded by the expiry date prefix; and
981
982
983
984
(f)
if the medicine is contained in an ampoule - a statement of the approved route
of administration for the medicine, such as ‘inhalation’, ‘For oral use only’ or
other phrase, word or abbreviation denoting the approved route(s) of
administration of the medicine; and
985
986
987
(g)
if the medicine contains only one active ingredient - the name of the active
ingredient and the quantity or proportion of the active ingredient in the
medicine, or suitable unambiguous abbreviation of the name and quantity.
988
989
(16)
Individually wrapped medicines
(a)
Subject to paragraph (b), if:
990
991
992
(i)
a medicine consists of individual dosage units such as tablets, capsules,
pills, pastilles, cachets, lozenges, pessaries, suppositories, single doses of
a powder, single doses of a liquid, or a transdermal patch; and
993
994
(ii)
each dosage unit is enclosed in an individual wrapper, sachet or blister,
whether sealed or unsealed; and
995
(iii) one or more dosage units are enclosed in a primary pack; and
996
997
(iv) the label on the primary pack complies with the requirements of this
Order,
998
999
then the label on each individual wrapper, sachet or blister must comply with
sections 8 and 9 except if the following information is set out on the label:
1000
(v)
1001
(vi) the name(s) of all active ingredients in the medicine; and
1002
(vii) the quantity or proportion of all active ingredients in the medicine; and
1003
1004
(viii) the batch number of the medicine preceded by the batch number
prefix; and
1005
(ix) the expiry date of the medicine preceded by the expiry date prefix; and
1006
1007
(x)
1008
(b)
the name of the medicine; and
the name of the sponsor or supplier, or registered trademark that readily
identifies the sponsor or supplier of the medicine.
If:
1009
(i)
the medicine consists only of pastilles or lozenges; and
1010
1011
(ii)
each dosage unit is individually wrapped in an unsealed protective cover;
and
1012
1013
(iii) each dosage unit is, after being so wrapped, enclosed in a primary pack
that complies with the requirements of this Order,
1014
1015
then the label for each individual wrapper must comply with sections 8 and 9
except if there is set out, on the individual wrapper, the name of the medicine.
Page 26 of 42
Section 10
1016
(c)
Qualifications and special requirements
Where:
1017
1018
(i)
a medicine consists of dry herbs contained in individual bags and the bag
is retained around the herbs during preparation; and
1019
1020
(ii)
the bags are contained in a primary pack, the label of which complies
with the requirements of this Order,
1021
1022
then the individual bag need not be labelled with the information referred to in
sections 8 and 9.
1023
1024
(d)
A transdermal patch must be labelled with one of the following markings that
remain on the patch after application to the patient:
1025
(i)
a code or other marking that is unique to the medicine; or
1026
1027
(ii)
the name of the medicine, and where there is more than one strength of
that medicine, an indicator of the strength; or
1028
1029
(iii) the name of the active ingredient(s) together with a statement of the
quantity of active ingredient(s) released in a stated time.
1030
1031
(17)
Strip, blister and dial dispenser packs
(a)
Subject to paragraph (b), if:
1032
1033
1034
(i)
a medicine consists of individual dosage units such as tablets, capsules,
pastilles, cachets, lozenges, pessaries, suppositories or single doses of
powder; and
1035
1036
1037
(ii)
two or more dosage units are individually enclosed in a strip, blister or
dial dispenser pack such that the dosage units can only be extracted
individually; and
1038
1039
(iii) the strip, blister or dial dispenser pack is enclosed in a primary pack,
the label of which complies with the requirements of this Order,
1040
1041
1042
then the label on the strip, blister or dial dispenser pack must comply with
sections 8 and 9 except where the following information is set out on that
label:
1043
(iv) the name of the medicine; and
1044
(v)
1045
(vi) the quantity or proportion of all active ingredients in the medicine; and
1046
1047
(vii) the batch number of the medicine preceded by the batch number
prefix; and
1048
(viii) the expiry date of the medicine preceded by the expiry date prefix; and
1049
1050
(ix) the name of the sponsor or supplier, or registered trademark that readily
identifies the sponsor or supplier of the medicine.
1051
(b)
the name(s) of all active ingredients in the medicine; and
If in relation to a medicine referred to in (a) there are:
1052
1053
(i)
four or more active ingredients in the medicine and the medicine is
intended to be, or is, registered goods; or
1054
1055
(ii)
two or more active ingredients in the medicine and the medicine is
intended to be, or is, listed goods,
Page 27 of 42
Section 10
Qualifications and special requirements
1056
1057
1058
then the label on the strip, blister or dial dispenser pack must comply with
sections 8 and 9 except if there are set out on that label, the following
information:
1059
(iii) the name of the medicine; and
1060
1061
(iv) the batch number of the medicine preceded by the batch number prefix;
(v) the expiry date of the medicine preceded by the expiry date prefix; and
1062
1063
(vi) the name of the sponsor or supplier, or registered trademark that readily
identifies the sponsor or supplier of the medicine.
1064
1065
1066
1067
1068
1069
1070
1071
(c)
(18)
In addition to the requirements referred to in paragraphs (a) and (b) as relevant,
if the strip or blister is not a calendar pack or does not contain multiple
formulations, then the name of the medicine, the name(s) of all active
ingredients in the medicine, if required, and the quantity or proportion of all
active ingredients in the medicine, if required, must appear on the label at
least once in relation to every two dosage units enclosed in the strip or blister.
Plastic ampoules
(a)
Subject to paragraph (b), if:
1072
1073
(i)
a medicine is contained in a plastic ampoule, whether or not it is a
medicine for injection; and
1074
1075
(ii)
the capacity of the container of the medicine in the plastic ampoule is
8 millilitres or less; and
1076
(iii) two or more ampoules are attached to a connecting strip; and
1077
1078
(iv) the ampoules and their connecting strip are enclosed in a primary pack
that complies with the requirements of this Order,
1079
1080
1081
then the information required by this Order to appear on the label of the
container of the medicine may be divided between the ampoule and the
connecting strip.
1082
1083
(b)
Whether or not the seal is broken when an ampoule is detached from the strip,
the following information must appear on the label of each ampoule:
1084
(i)
the name of the medicine; and
1085
(ii)
the quantity or proportion of all active ingredients in the medicine; and
1086
1087
(iii) the batch number of the goods preceded by the batch number prefix;
and
1088
(iv) the expiry date of the goods preceded by the expiry date prefix; and
1089
1090
(v)
the approved route(s) of administration followed by the word ‘only’
and/or warnings against use by other routes of administration.
1091
1092
1093
1094
(c)
If a medicine is contained in a plastic ampoule which has a container with a
capacity of 25 millilitres or less, but greater than 8 millilitres, then the
requirements of subsection 10(4), 10(8) or subsection 10(14), as relevant, apply
notwithstanding the container being a plastic ampoule.
1095
1096
(d)
If a medicine is contained in a plastic ampoule which has a container with a
capacity greater than 25 millilitres, then the requirements of subsection 10(3)
Page 28 of 42
Section 10
1097
1098
1099
Qualifications and special requirements
or subsection 10(2) or subsection 10(8), as relevant, apply notwithstanding the
container being a plastic ampoule.
(19)
Composite packs
1100
1101
1102
(a)
The expiry date on the package that, together with medicines, constitutes a
composite pack must be the earliest of the expiry dates of the medicines that
constitute the composite pack.
1103
1104
1105
(b)
The storage conditions on the package that, together with medicines,
constitutes a composite pack must be the most restrictive of the storage
conditions of the medicines that constitute the composite pack.
1106
1107
1108
1109
Note:
(20)
The label on the container and primary pack (if any) of each medicine
comprising a composite pack must comply with this Order.
Registered medicines that require a Medicine Information panel
(a)
The requirements in this subsection do not apply to:
1110
1111
(i)
medicines containing substances included in Schedule 4 or Schedule 8 of
the Poisons Standard;
1112
(ii)
human blood products included in Appendix A of the Poisons Standard;
1113
(iii)
medicines for injection; or
1114
1115
(iv)
the container label for a medicine where subsection 10(14) or 10(15) of
this Order applies in relation to the medicine.
1116
1117
1118
1119
(b)
1120
1121
1122
1123
1124
1125
1126
In addition to the requirements of section 9, the label on the container and
label on the primary pack (if any) of a medicine to which this subsection
applies must contain an information panel as shown in Schedule 2 of this Order
that:
(i)
contains the information required by paragraphs 8(1)(b), (c), (j), (l), and
(n); and
(ii) contains the information required by paragraph 8(1)(k), unless there is a
contrary requirement as to the location of a specific warning statement;
and
(iii) may contain additional information under the heading ‘Other
information’.
1127
1128
1129
(c)
The information panel is to be titled Medicine Information displayed in a text
size that is no smaller than the text size used for the headings required to be
included in that panel.
1130
1131
1132
(d)
Subject to paragraph (f), the information required by this subsection to be
included in the Medicine Information panel is to be presented in black text with
white background.
1133
1134
1135
(e)
The information, when required, is to be presented in the following order in the
Medicine Information panel under the headings: Ingredients, Uses OR What
this medicine is used for, Warnings, Directions for use, Other information.
1136
1137
1138
1139
(f)
The headings Ingredients, Uses OR What this medicine is used for, Warnings,
Directions for use and Other information in the Medicine Information panel are
to be highlighted by the use of bold fonts, shading, box-borders, colour or by
other suitable means.
Page 29 of 42
Section 11
How information is to be expressed
1140
1141
1142
1143
1144
(g)
Where relevant, the warning statements in the Medicine Information panel
are to be grouped under subheadings such as ‘Do not use if’, ‘Ask a doctor or
pharmacist before use if you’ and ‘Stop use and ask a doctor if’. These
subheadings are to be presented in bold fonts but must use text sizes that are
smaller than the text size used for the headings.
1145
1146
(h)
A horizontal hairline is to be used below each of the subheadings under
‘Warnings’ in the Medicine Information panel.
1147
1148
(i)
The title, headings and subheadings in the Medicine Information panel are to
be left justified.
1149
1150
1151
(j)
Unless specified otherwise, use of uppercase letters is to be avoided in the
Medicine Information panel and the information is to be presented in sentencecase format using capital letters at the beginning of sentences.
1152
1153
(k)
The Medicine Information panel must not be broken up by non-mandatory
information, logos or graphics.
1154
1155
1156
(l)
Where it is impractical to include the entire Medicine Information panel on one
panel of the label, then the Medicine Information panel can be continued
elsewhere on the label, and if so:
1157
1158
(i)
the format and order of information required by this subsection to be
included in the Medicine Information panel must be retained; and
1159
1160
1161
1162
(ii)
the continuation of the Medicine Information panel must be signalled by
placing the word ‘continued...’at the right bottom corner of the first panel
and the subsequent Medicine Information panel(s) titled ‘Medicine
Information (continued)’.
1163
1164
1165
1166
1167
11
How information is to be expressed
(1)
Use of appropriate metric units
(a)
For active ingredient(s), where a particular is a statement of mass for which
there is a metric unit of measurement, the metric units must be expressed as
follows:
1168
1169
(i)
a statement of quantity for 1 microgram up to 999 micrograms inclusive
must be expressed in terms of micrograms;
1170
1171
(ii)
a statement of quantity for 1000 micrograms may be expressed as either
1000 micrograms or 1 milligram;
1172
1173
(iii) a statement of quantity for more than 1 milligram up to 999 milligrams
inclusive must be expressed in terms of milligrams;
1174
1175
(iv) a statement of quantity for 1000 milligrams may be expressed as either
1000 milligrams or 1 gram; and
1176
1177
(v) a statement of quantity for more than 1 gram up to 999 grams inclusive
must be expressed as grams.
1178
1179
1180
1181
(b)
Page 30 of 42
Where a range of medicines contains the same active ingredient(s) in the same
dosage form in a series of strengths then the label must state the quantity of
each active ingredient in terms of either the highest or lowest metric unit of
measurement in the series of strengths.
Section 11
1182
1183
1184
1185
How information is to be expressed
Example:
1186
1187
(c)
1188
1189
1190
1191
A range of expressions for active ingredient would be stated as
0.5 milligram, 1 milligram and 5 milligrams, or 500 micrograms, 1000
micrograms and 5000 micrograms, rather than 500 micrograms,
1 milligram and 5 milligrams.
Where the active ingredient is in liquid form, the equivalent metric units of
volume must be expressed in the same manner.
Example:
A statement of volume for more than 1 millilitre up to 999 millilitres
inclusive must be expressed in terms of millilitres, but a statement of
volume for 1000 millilitres may be expressed as either 1000 millilitres
or 1 litre.
1192
1193
1194
(d)
Where the information is a statement of mass or volume, the unit of
measurement must be consistent with the unit of measurement used in any
warning statement required for that ingredient.
1195
1196
(e)
Where a statement of quantity is expressed as less than one (1) unit, the
statement of quantity must include the leading zero.
1197
(2)
Expression of quantity or proportion of active ingredients
1198
1199
Subject to subsections 11(3), 11(4) or 11(5) below, the quantity or proportion of an
active ingredient to be included on a label must be expressed:
1200
1201
(a)
for a discrete dosage unit - as the quantity of the active ingredient in the
dosage unit;
1202
1203
1204
(b)
for a solid for ingestion, where there is no discrete dosage unit - as the quantity
of the active ingredient contained in the stated weight of a suitable dose of the
solid;
1205
(c)
subject to paragraph (d) below, if the medicine is a liquid for ingestion:
1206
1207
(i)
as the quantity of the active ingredient contained in the stated volume of
a suitable dose of the liquid; or
1208
1209
1210
1211
1212
(ii)
in the case where the liquid for ingestion is one of a series of strengths
containing the same active ingredient – as the quantity of the active
ingredient contained in the stated volume of a suitable dose of the liquid
with the quantity or proportion of active ingredient expressed
consistently across the series in terms of the same stated dose volume.
1213
1214
1215
1216
Example:
(d)
1217
Where the dose volume is 5 mL, and there are strengths of 1
mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL
and 25 mg in 5 mL, respectively.
for a medicine required to be prepared before use, and:
(i)
where the process results in a medicine that is a liquid for ingestion:
1218
1219
1220
1221
(A) as the quantity of the active ingredient contained in the stated
volume of a suitable dose of the liquid after preparation in
accordance with the instructions set out on the label of the
medicine; or
1222
1223
1224
(B)
Page 31 of 42
in the case where the medicine is one of a series of strengths
containing the same active ingredient - as the quantity of the
active ingredient contained in the stated volume of a suitable dose
Section 11
How information is to be expressed
1225
1226
1227
1228
of the liquid after preparation in accordance with the instructions
set out on the label of the medicine with the quantity or proportion
of active ingredient expressed consistently across the series in
terms of the same stated dose volume; and
1229
1230
1231
Example:
1232
1233
1234
Where the dose volume is 5 mL, and there are strengths of 1
mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL
and 25 mg in 5 mL, respectively.
(ii) for any other medicines - as the weight or volume of active ingredient in
a stated weight or volume of the medicine, after preparation in
accordance with the instructions included in the label of the medicine;
1235
1236
1237
(e)
for a transdermal patch, intrauterine drug delivery system or implant - as the
total quantity of the active ingredient in each patch, drug delivery system or
implant and the quantity of the active ingredient released in a stated time;
1238
(f)
for a medicine for injection:
1239
1240
1241
1242
(i)
where the medicine is a powder for injection or a concentrated solution
for injection – as the nominal quantity (the dose delivered to the patient
when the dose is administered as directed) of the active ingredient in the
container;
1243
1244
(ii)
where the nominal volume of the medicine for injection is greater than
100 millilitres and the medicine is intended:
1245
(A) for electrolyte replacement or nutritional therapy; or
1246
(B) as a plasma volume expander; or
1247
(C) as an additive to any of these types of injection,
1248
then:
1249
1250
1251
(D) as the number of millimoles in the nominal volume of the injection
in the container for each active ingredient or ion of precisely
known molecular weight; or
1252
1253
1254
(E)
as the weight contained in the nominal volume of the injection in
the container for each active ingredient for which the molecular
weight is not precisely known;
1255
1256
1257
1258
1259
(iii) where the nominal volume of the medicine for injection is greater than
100 millilitres and the medicine contains an active ingredient which is
not intended for electrolyte replacement or nutritional therapy or as a
plasma volume expander - as the weight of the active ingredient in the
nominal volume of injection in the container;
1260
(iv) where the medicine for injection is intended for multidose use:
1261
1262
1263
(A) where the nominal volume in the container is greater than
1 millilitre - as the quantity of the active ingredient in one
millilitre of the injection; and
1264
1265
1266
(B)
Page 32 of 42
the volume in the container is less than or equal to 1 millilitre - as
the quantity of the active ingredient in a suitable dose volume of
the injection;
Section 11
1267
1268
1269
(v)
How information is to be expressed
where the injection is a small volume injection and is usually intended
for administration as a single dose - as the quantity of active ingredient
in the stated volume of the injection in the container.
1270
1271
1272
(g)
for antibiotic preparations, where potency units are used as a measure of
activity - as the number of such units expressed as International Units (IU)
established by the World Health Organization;
1273
1274
1275
1276
(h)
for preparations applied to the skin and mucous membranes, other than those
covered by paragraphs (g) and (i) - as a percentage expressed in terms of w/w,
w/v, v/v or v/w, as appropriate, or as the weight or volume in a stated weight or
volume of the medicine, as appropriate;
1277
1278
(i)
for pressurised metered dose inhalers, dry powder inhalers and other metered
dose products such as nasal sprays:
1279
1280
1281
(i)
in the case of a medicine where the dose has been established as the
delivered dose– as the quantity of active ingredient delivered per
metering; or
1282
1283
1284
(ii)
in the case of a medicine that is the subject of a monograph of the British
Pharmacopoeia and the dose has been established as a metered dose – the
metered quantity of active ingredient; or
1285
1286
1287
1288
(iii) where the medicine is a powder for inhalation is supplied in the form of
a capsule, or as a well in a blister tray or other suitable pharmaceutical
form and labelling with the delivered dose is not established - as the
quantity of active ingredient in each dosage unit;
1289
1290
1291
(j)
Notwithstanding the requirements in paragraphs 11(2)(a) –11(2)(i), the
following requirements apply in the circumstances specified in the following
subparagraphs, in addition to the requirements set out in those paragraphs:
1292
1293
1294
(i)
for preparations that are enzymes – as the activity unit specified in
Column 1 of Schedule 3 to this Order in relation to a particular enzyme
set out in Column 3 of that Schedule;
1295
1296
1297
(ii)
for medicines containing an active ingredient which is a herbal
material, such as a dry, fresh, milled or powdered herb – as the weight of
the herbal material and
1298
1299
1300
1301
(A) where standardisation of the herbal material is claimed on the
label of the medicine – the minimum dry weight or minimum fresh
weight of herbal material and also the quantity of standardised
component(s) in the herbal material
1302
(iii) for medicines containing a herbal preparation:
1303
1304
(A) where the preparation is an essential oil - as the quantity of the
herbal preparation; or
1305
1306
1307
(B)
where the preparation is a fresh, concentrated, dry or diluted juice as the dry weight or fresh weight of the herbal material from
which the juice was derived; or
1308
1309
1310
(C)
where standardisation of the herbal preparation is claimed on
the label of the medicine – the minimum dry weight or minimum
fresh weight of herbal material from which the preparation is
Page 33 of 42
Section 11
How information is to be expressed
1311
1312
derived and also the quantity of standardised component(s) in the
herbal preparation; or
1313
1314
1315
(D) where the preparation is not mentioned under subsubparagraphs
(A), (B), or (C) - as the dry or fresh weight of the herbal material
from which the preparation was derived;
1316
1317
(iv) for oral preparations containing trace elements as salts - as the quantity of
the element with the name of the salt being indicated;
1318
1319
(v)
1320
1321
1322
(vi) for a preparation containing biological organisms - as the number of
organisms present per metric unit for liquids and powders and as the
number of organisms present per dosage unit for other dosage forms;
1323
(k)
for preparations containing Vitamin A - as the quantity or proportion of
Vitamin A expressed in terms of microgram retinol equivalents;
for any other medicines:
1324
1325
1326
(i)
where the medicine is a liquid and includes an active ingredient which
is a liquid - as the appropriate amount of the active ingredient, either by
weight or volume, in a stated volume of the medicine;
1327
1328
1329
(ii)
where the medicine is a liquid and includes an active ingredient which
is a solid - as the weight of active ingredient in a stated volume of the
medicine;
1330
1331
1332
(iii) where the medicine is a liquid and includes an active ingredient which
is a gas - as the weight of the active ingredient in a stated volume of the
medicine;
1333
1334
1335
(iv) where the medicine is a solid and includes an active ingredient which is
a liquid - as the appropriate amount of the active ingredient, either by
weight or volume, in a stated weight of the medicine;
1336
1337
1338
(v)
1339
1340
(3)
where the medicine is a solid and includes an active ingredient which is
a solid - as the weight of the active ingredient in a stated weight of the
medicine.
Expression of quantity or proportion of active ingredients for
homoeopathic preparations
1341
1342
The label on the container and on the primary pack of a medicine that contains a
homoeopathic preparation must include:
1343
1344
1345
(a)
where the medicine is a fully potentised, single ingredient, homoeopathic
medicine and it is clear that the ingredient comprises 100% of the medicine –
the name of the active ingredient; or
1346
1347
1348
(b)
where all active ingredients of the medicine are homoeopathic preparations
and are all included in the medicine in the same proportion - as ‘Contains equal
parts of ...’ followed by the name of each active ingredient; or
1349
1350
(c)
where paragraphs (a) and (b) do not apply- the quantity of the preparation in
one millilitre or in one gram of the medicine
Page 34 of 42
Section 11
1351
(4)
1352
1353
How information is to be expressed
Expression of potency in biological medicines
(a)
For a liquid biological medicine or a biological medicine required to be
prepared before use, the potency:
1354
(i)
must be included on the label of the medicine; and
1355
1356
1357
(ii)
must be expressed as potency units, or weight of active ingredient per
dose or per unit volume, or as the volume which contains the
recommended dose.
1358
1359
1360
1361
1362
1363
1364
1365
(b)
(5)
The potency unit to be used must be:
(i) the International Unit (IU) established by the World Health Organization;
or
(ii) where IU have not been established, then the potency unit to be used is
that specified in the approved product details in relation to the
medicine.
Expression of activity of radionuclides in radiopharmaceutical
preparations
1366
1367
The quantity or proportion of an active ingredient which is a radionuclide and is
included in a radiopharmaceutical preparation must be:
1368
(a)
included on labels; and
1369
1370
(b)
expressed in terms of the total activity of the radionuclide in the container, in
becquerels, at a specified date and hour.
1371
1372
1373
(6)
Permitted statements of storage temperature conditions
For the purposes of this Order, the following statements of storage temperature
conditions are permitted:
1374
(i)
‘Store below –18oC (Deep freeze)’;
1375
(ii)
‘Store below –5oC (Freeze)’;
1376
(iii) ‘Store below 8oC (Refrigerate)’;
1377
(iv) ‘Store at 2oC to 8oC (Refrigerate. Do not freeze)’;
1378
(v)
1379
(vi) ‘Store below 30oC’; and
1380
1381
1382
(vii) for a medicine that is, or is intended to be, registered goods, any other
storage temperature and conditions as specified in the approved product
details in relation to the medicine.
1383
Page 35 of 42
‘Store below 25oC’;
Section Schedule 1
Schedule 1
Substances or Groups of substances present in medicines that are
required to be declared on the label of medicines
Column 1 includes a general descriptor for the substance or group of substances required to be
declared on the label of medicines, and a number of indicative substances names for particular
groups of substances.
Column 2 specifies the circumstance, such as specified concentration of the substance when present
in the medicine or specified amounts of substances contained in the medicine, where if it occurs
require the particular declaration on the label identifying the particular substance or group of
substances set out in column 1, and provides additional required statements that are supplemental to
the required declaration on the label. Where there are no circumstances specified in column 2, then
the presence of the substance or group of substances is required to be declared on the label
irrespective of any circumstance, concentration or amount of the substance or group of substances
present in the medicine.
Column 3 identifies those routes of administration of the medicine containing the substance or
group of substances, where for the purposes of this Schedule and taking into consideration any
circumstance specified in column 2, the substance or group of substances must be declared on the
label.
Column 4 identifies the name of the substance, the group of substances or a general descriptor of the
substance to be included on the label of the medicine where the particular substance or group of
substances are present in the medicine. The name also describes a group of substances that have
similar characteristics and is to be used irrespective of whether one or more of the substances in the
group are present in the formulation. Presentation on the label must be in the form “Contains ‘Name
(as set out under Column 4)’”.
Column 1
Substance name or
Group of substances
name
Column 2
Circumstances (if any) and
additional requirements (if any)
Column 3
Route of
administration
Column 4
Name to be
includes on the
label
aspartame
Oral
aspartame
benzoates, including:
benzoic acid
sodium benzoate
crustacea and crustacean
products (see Note 1),
including:
crab
lobster
white shrimp
egg and egg products,
including:
dried egg yolk
egg lecithin
All
benzoates
All
crustacea; or
crustacean
products
All
egg; or
egg products
Page 36 of 42
Section Substances or Groups of substances present in medicines that are required to be declared on
the label of medicines
ethanol
Circumstance: Where present in a
concentration of 3% v/v or more.
All
alcohol
All
fish; or
fish products
Oral
All, other than
skin and mucous
membrane
applications
All
galactose
Gluten
Oral
All
lactose
milk; or
milk products
All
peanuts; or
peanut products
All, other than
skin an mucous
membrane
applications
Oral
Oral
phenylalanine
Requirement: To declare on the
label the quantity of ethanol as
% v/v.
fish and fish products (see
Note 2), including:
cod
cod – liver oil
halibut
tuna
galactose
gluten or ingredient derived
from gluten-containing grain
(see Note 3)
Circumstance: Where gluten or an
ingredient derived from glutencontaining grain is present.
hydroxybenzoic acid esters,
including:
ethyl hydroxybenzoate
methyl hydroxybenzoate
propyl hydroxybenzoate
sodium ethyl
hydroxybenzoate
sodium methyl
hydroxybenzoate
sodium propyl
hydroxybenzoate
lactose (see Note 4)
milk and milk products,
including (see Note 4):
casein
hydrolysed milk protein
nonfat dry milk
whey powder
whole dry milk
peanuts and peanut
products, including:
Arachis hypogaea
arachis (peanut) oil
Phenylalanine
pollen
potassium salts, including:
potassium bicarbonate
potassium chloride
Circumstance: Where the total
potassium content of the dose is
greater than 39 mg (1mmol)
elemental potassium per dose
Requirement: To declare on the
label (in mg) the quantity of
elemental potassium per dose.
Page 37 of 42
hydroxybenzoates
pollen
potassium
Section Substances or Groups of substances present in medicines that are required to be declared on
the label of medicines
propolis
royal jelly
saccharin, including:
saccharin calcium
saccharin sodium
sesame seeds and sesame
seed products, including:
sesame seed
sesame oil
Sesamum indicum
sodium salts, including:
sodium bicarbonate
sodium chloride
Circumstance: Where the total
sodium content of the maximum
recommended daily dose of the
formulation is greater than 120 mg of
elemental sodium per dose.
Oral
Oral
Oral
propolis
royal jelly
saccharin
All
sesame seeds; or
sesame seed
products
Oral
sodium
All
soya beans; or
soya bean products
All
sorbates
Oral
sucralose
Requirement: To declare on the
label (in mg) the quantity of
elemental sodium per dose.
soya beans and soya bean
products, including:
Glycine max
soya bean
soya oil
excluding:
 soya oil that is fully
refined;
 d-alpha tocopherol, dalpha tocopheryl acetate,
d-alpha tocopheryl acid
succinate, mixed (highalpha type) tocopherols
concentrate, or mixed
(low-alpha type)
tocopherols concentrate
when derived from
soybean sources;
 vegetable oils derived
phytosterols and
phytosterol esters from
soybean sources;
 plant stanol ester produced
from vegetable oil sterols
from soybean sources.
sorbates, including:
potassium sorbate
sorbic acid
sucralose
Page 38 of 42
Section Substances or Groups of substances present in medicines that are required to be declared on
the label of medicines
sugar alcohols, including:
erythritol
isomalt
lactitol
maltitol
mannitol
polydextrose
sorbitol
xylitol
sugars – monosaccharides
and disaccharides (see Note
5), including:
fructose
glucose
honey (as a mixture of
sugars)
invert sugar
lactose
maltose
sucrose
sulfites, including: (see Note
6)
potassium metabisulfite
sodium bisulfite
sodium metabisulfite
sodium sulfite
sulfur dioxide
tartrazine
tree nuts and tree nut
products (see Note 7),
including:
almond oil
Juglans nigra
macadamia nut oil
Macadamia ternifolia
Prunus dulcis
walnut
Page 39 of 42
Circumstance: Where the total sugar
alcohol content of the formulation
exceeds 2 g per maximum
recommended daily dose.
Requirement: To declare on the
label the quantity of sugar alcohols
present per recommended maximum
daily dose; and a statement 'Products
containing (name of sugar alcohol)
may have a laxative effect or cause
diarrhoea'.
Circumstance: Where the presence
of sugars may have a significant
glycaemic effect and the total sugar
content (including lactose which
requires a separate declaration)
exceeds 100 mg per recommended
daily dose.
Oral
sugar alcohols; or
name of sugar
alcohol
Oral
sugars
All
sulfites
All
All
tartrazine
tree nuts; or
tree nut products
Section Substances or Groups of substances present in medicines that are required to be declared on
the label of medicines
Note 1: Crustacea include various species of aquatic animals which have an inedible chitinous outer
shell. These include but are not limited to crab, crayfish, lobster, prawn and shrimp.
Note 2: Fish includes freshwater fish, diadromous fish and marine fish, including shark.
Note 3: Gluten – some formulations of medicines may contain gluten that is present naturally as a
constituent of an ingredient such as wheat starch.
Note 4: Lactose, where obtained from milk, does not require the ‘contains milk product’ statement.
Note 5: Sugars – monosaccharides and disaccharides – some sugar derivatives may not have a
significant impact on glycaemic control. Lactose forms part of total sugars for the purposes of
determining if the sugars will have a significant glycaemic effect and for calculating the total daily
dose. Where lactose is present in the medicine, the entries under ‘lactose', ‘sugars –monosaccharides
and disaccharides' and ‘milk and milk products’ (if of dairy origin) each apply.
Note 6: Sulfur dioxide – some formulations of medicines may contain sulfur dioxide as a residue, for
example, gelatin, but must be identified.
Note 7: Tree nuts are the seeds of a variety of trees and shrubs which are characterised by a hard
inedible shell enclosing an oily seed. Tree nuts include almond, Brazil, cashew, chestnut, and walnut.
Coconut is the fruit of the palm (Cocos nucifera) and is not considered to be a tree nut.
Page 40 of 42
Section Schedule 2
Schedule 2
Format of Medicine Information panel
Medicine Information
Ingredient(s)
Each tablet/capsule/xx mL dose contains the active ingredient(s)
xxxxxxxxx mg/mL/%
xxxxxxxxx mg/mL/%
Also contains xxxx, xxxx and xxxx (name of Schedule 1 substance or
group of substances).
Uses OR What this medicine is used for
For the temporary relief of:
 xxxx  xxxxxxxxxxxxxx  xxxxxxxxxxxxxxxxxx
Warnings
Do not use if


xxxxxxxxxxxxxxxxxxxxxxx  xxxxxxxxx
xxxxxxxxx  xxxxxxxxx
Ask a doctor or pharmacist before use if
 xxxxxxxxxxxxxx  xxxxxxxxx  xxxxxxxxx
 xxxxxxxxx
Stop use and ask a doctor if
 xxxxxxxxxxxxxxxxxxx  xxxxx
Other warnings, grouped under suitable subheadings.
Directions for use
Approved directions for use, for example:
Take x tablet every x-x hours as required. Do not take more than x in a xx
hour period.
Do not exceed the recommended dose
Other information
Inclusion of this sub-heading and additional information under this
section of the information panel is optional. Examples of information that
can be included here are storage conditions, sponsor contact details, other
information about tamper evident features.
Page 41 of 42
Section Schedule 3
Schedule 3
Specified Units for Enzymes
Column 1
Unit
Column 2
Unit Description
Column 3
Permitted Ingredients
actinidain units
Actinidain units
actinidain (of Actinidia
deliciosa and chinensis)
ALU
Acid lactase units
Tilactase
ALU/g
Acid lactase unit per gram
Tilactase
CU
Cellulase unit
Cellulase
CU/g
Cellulase unit per gram
Cellulase
DUAA
Alpha-amylase dextrinising unit
Amylase
DU/g
Dextrinising unit per gram
Amylase
HUT
Haemoglobin units on the tyrosine basis
Protease
HUT/g
Haemoglobin unit on the tyrosine basis per
gram
Protease
LipU
Lipase units
Lipase
LipU/g
Lipase unit per gram
Lipase
thousand ALU
Thousand Acid lactase unit
Tilactase
thousand ALU/g
Thousand Acid lactase units per gram
Tilactase
thousand CU
Thousand cellulase unit
Cellulase
thousand CU/g
Thousand cellulase unit per gram
Cellulase
thousand DUAA Thousand alpha-amylase dextrinising unit
Amylase
thousand
DUAA/g
Thousand alpha-amylase dextrinising unit
per gram
Amylase
Thousand HUT
Thousand haemoglobin units on the tyrosine Protease
basis
Thousand
HUT/g
Thousand haemoglobin units on the tyrosine Protease
basis per gram
thousand LipU
Thousand lipase unit
Lipase
thousand LipU/g Thousand lipase units per gram
Lipase
USP Unit
Caricain (of Carica
papaya)
Page 42 of 42
United States Pharmacopoeial Unit