(9) Strip, blister and dial dispenser pa(9) Strip, blister and dial dispenser packs

(9) Strip, blister and dial dispenser packs

(a) Subject to paragraph (b), if:

(i) a medicine consists of individual dosage units such as tablets, capsules, pills, pastilles, cachets, lozenges, pessaries, suppositories or single doses of powder; and

(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

(iii) the strip, blister or dial dispenser pack is enclosed in a primary pack, the label of which complies with sections 8 and 9,

then, in relation to compliance of the label on the strip, blister or dial dispenser pack with sections 8 and 9, it shall be sufficient if the following information is displayed:

(iv) the name of the medicine; and

(v) the name(s) of all active ingredients in the medicine; and

(vi) the quantity or proportion of all active ingredients in the medicine; and

(vii) the batch number of the medicine preceded by the batch number prefix; and

(viii) the expiry date of the medicine preceded by the expiry date prefix; and

(ix) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.

(b) If, in relation to a medicine referred to in (a) there are:

(i) four or more active ingredients in the medicine and the medicine is intended to be, or is, registered goods; or

(ii) two or more active ingredients in the medicine and the medicine is intended to be, or is, listed goods,

then, in relation to compliance of the label on the strip, blister or dial dispenser pack with sections 8 and 9, it shall be sufficient if the following information is displayed:

(iii) the name of the medicine; and

(iv) the batch number of the medicine preceded by the batch number prefix; and

(v) the expiry date of the medicine preceded by the expiry date prefix; and

(vi) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.

(c) In addition to the requirements referred to in paragraphs 10(9)(a) and (b) as relevant, if each dosage unit is enclosed in the strip or blister such that an individual segment containing the dosage unit can be readily detached, then the following information must appear on the label of the strip or blister at least once in relation to every two dosage units:

(i) for a medicine to which paragraph 10(9)(a) applies – the name of the medicine, the name(s) of all active ingredients in the medicine and the quantity or proportion of all active ingredients in the medicine; and