Medicines Regulations 1984

  • 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

(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:

(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:

(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).