Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
(8) Individually wrapped medicines(8) Individually wrapped medicines
Start here
Get a plain-English read of (8) Individually wrapped medicines
Turn the raw legal text into a practical explanation grounded in Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.
(8) Individually wrapped medicines
(a) Subject to paragraph (b), if:
(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
(ii) each dosage unit is enclosed in an individual wrapper or blister, whether sealed or unsealed; and
(iii) one or more dosage units are enclosed in a primary pack; and
(iv) the label on the primary pack complies with sections 8 and 9,
then, in relation to compliance of the label on each individual wrapper or blister with sections 8 and 9, it shall be sufficient if the following information is displayed:
(v) the name of the medicine; and
(vi) the name(s) of all active ingredients in the medicine; and
(vii) the quantity or proportion of all active ingredients in the medicine; and
(viii) the batch number of the medicine preceded by the batch number prefix; and
(ix) the expiry date of the medicine preceded by the expiry date prefix; and
(x) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.
(b) If:
(i) the medicine consists only of pastilles or lozenges; and
(ii) each dosage unit is enclosed in an unsealed individual wrapper; and
(iii) each dosage unit is, after being so wrapped, enclosed in a primary pack that complies with sections 8 and 9,
then, in relation to compliance of the label for each individual wrapper with sections 8 and 9, it shall be sufficient if the name of the medicine is displayed.
(c) Where:
(i) a medicine consists of dry herbs contained in individual bags and the bag is retained around the herbs during preparation; and
(ii) the bags are contained in a primary pack, the label of which complies with the requirements of this Order,
then the individual bag need not be labelled with the information referred to in sections 8 and 9.