Commonwealth Numbered Regulations

1992 No. 430 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 7

7.1 Add at the end:
                          SCHEDULE 12             Subregulation 9A (1)

PATIENT INFORMATION DOCUMENTS A patient information document about a medicinal
product must be:
. written in English
. clearly legible
. written in language that will easily be understood by patients
. consistent with product information (within the meaning of section 32 of the
Act) about the product. A patient information document must include the
following: 1. Identification The name of the medicinal product, which is the
name given to the product by the sponsor, including or followed by the
non-proprietary name(s) of the active ingredient(s) and the dosage form or
strength, or both, of the product. A statement of the active ingredients
expressed quantitatively and excipients expressed qualitatively, using their
common names, in the case of each presentation of the product. The
pharmaceutical form and the contents by weight, volume or number of doses of
the product, in the case of each presentation of the product, together with
its identifying Australian Register number. 2. What the product is used for
and how it works The therapeutic indications, unless a competent authority
determines that dissemination of such information may have serious
disadvantages for the patient. The pharmaco-therapeutic group, or type of
activity, if there is a term that is easily comprehensible for the patient. If
not, a simple description of what the medicinal product is for and how it
works, in 1 or 2 sentences. 3. Advice before using the medicinal product A
list of factors that are useful to consider before taking the medicinal
product, including, if appropriate:
. contraindications, including consideration of whether the patient has
experienced previous allergic reactions
. precautions for use, taking into account the particular condition of certain
categories of users, such as the elderly, children, infants, pregnant or
breastfeeding women, persons with specific pathological conditions
. potential effects of the medicinal product on the ability to drive vehicles
or to operate machinery
. interactions with other medicinal products or other forms of interaction
(for example with alcohol, tobacco, foodstuffs) which may affect the action of
the product
. special warnings, such as effects on sensitivity to sun exposure. 4. How to
use the medicinal product properly The necessary and usual instructions for
proper use of the medicinal product, in particular:
. the dosage, together with an indication that this may not always apply and
may be modified by the prescriber
. the method and, if necessary, route of administration
. the frequency of administration, specifying, if necessary, the appropriate
time at which the medicinal product should or must be used In addition,
depending upon the nature of the therapeutic goods:
. the duration of treatment, if it should be limited
. the expected effect of using the medicinal product
. what to do if 1 or more doses have not been taken
. the way the treatment should be stopped, if stopping the treatment may lead
to withdrawal or other adverse effects. 5. Further information For example,
habit forming potential, whether a doctor's prescription is required. 6.
Unwanted effects A description of the undesirable effects that can occur under
normal use of the medicinal product and, if necessary, the action to be taken
if experienced. The patient should be expressly invited to communicate any
undesirable effect, especially if it is not mentioned in the patient
information document, to his or her doctor or pharmacist. 7. In case of
overdose The action to be undertaken in the case of overdose (for example,
symptoms and emergency procedures). 8. Storage conditions An indication of the
appropriate storage conditions; a reference to the expiry date indicated on
the label, with a warning against using the medicinal product after this date;
if appropriate, a warning against visible signs of deterioration. 9. Where to
go for further information A direction to patients to discuss any aspect with
the doctor or pharmacist and, if appropriate, where further information may be
obtained. 10. Sponsor The name and address of the Australian sponsor of the
medicinal product. 11. Date of information The date on which the patient
information document was last revised.
Note 1: "Common name" is the international non-proprietary name recommended by
WHO or, if one does not exist, the usual common name. Note 2: The information
need not appear in the order outlined above. For example, the subsidiary
information under

"Identification" could appear at the end of the patient information document.