(1) Every container of a related product must, unless otherwise provided by these regulations, bear a label containing the following information:
(a) the trade name of the related product or, if there is no trade name, the appropriate designation of the related product:
(b) the name of each active ingredient:
(c) the appropriate quantitative particulars of each active ingredient:
(d) a description of the related product that indicates the true nature of the related product:
(e) a statement of the net weight or volume or number of the contents of the container, as the case may require:
(f) any warning statement required by these regulations for the related product:
(g) in the case of a related product sold, or intended for sale, for external use,—
(i) a statement of directions for use and frequency of use; and
(ii) the words “Caution: not to be taken”, or “For external use only”, or words of a similar meaning:
“Caution: not to be taken”
“For external use only”
(h) in the case of a related product sold, or intended for sale, for internal use,—
(i) the dose recommended; and
(ii) the frequency of that dose:
(i) the words “Batch Number” or “Lot Number”, or the word “Batch” or “Lot”, or the letter “B” (either alone or inside a circle) followed by the batch or lot number of the related product:
“Batch Number”
“Lot Number”
“Batch”
“Lot”
“B”
(j) where appropriate, an expiry date:
(k) the name and address of—
(i) the manufacturer or seller of the related product; or
(ii) the owner of the rights of manufacture; or
(iii) the agent of any person who comes within subparagraph (i) or (ii).
(2) For the purposes of subclause (1)(k),—
(a) an address at a post office is not sufficient:
(b) the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the related product is wholly manufactured and packed outside New Zealand:
(c) in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is sufficient.
Regulation 14: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).