Medicines Regulations 1984

  • not the latest version
  • This version was replaced on 7 November 2018 to make corrections to Schedule 1 Part 1 item 787 under section 25(1)(j)(ii) of the Legislation Act 2012.
14 Labelling of related products


Every container of a related product must, unless otherwise provided by these regulations, bear a label containing the following information:


the trade name of the related product or, if there is no trade name, the appropriate designation of the related product:


the name of each active ingredient:


the appropriate quantitative particulars of each active ingredient:


a description of the related product that indicates the true nature of the related product:


a statement of the net weight or volume or number of the contents of the container, as the case may require:


any warning statement required by these regulations for the related product:


in the case of a related product sold, or intended for sale, for external use,—


a statement of directions for use and frequency of use; and


the words “Caution: not to be taken”, or “For external use only”, or words of a similar meaning:


in the case of a related product sold, or intended for sale, for internal use,—


the dose recommended; and


the frequency of that dose:


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:


where appropriate, an expiry date:


the name and address of—


the manufacturer or seller of the related product; or


the owner of the rights of manufacture; or


the agent of any person who comes within subparagraph (i) or (ii).


For the purposes of subclause (1)(k),—


an address at a post office is not sufficient:


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:


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).