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.
15 Exemptions from regulations 13 and 14

(1)

Nothing in regulation 13 (except subclause (1)(a), (b), (c), (m), and (n)) and nothing in regulation 14 (except subclause (1)(a), (b), (c), (i), and (j)) applies to—

(a)

a container that—

(i)

contains a single dose of a medicine or related product; and

(ii)

is made of sheet material; and

(iii)

is not attached to another container; and

(iv)

is contained in a package that complies with regulation 13 or 14 (as the case requires); and

(v)

is not intended for sale other than in that package:

(b)

a container that—

(i)

contains a single dose of a medicine or related product; and

(ii)

is not made of sheet material; and

(iii)

has a volume of 20 millilitres or less; and

(iv)

is contained in a package that complies with regulation 13 or 14 (as the case requires); and

(v)

is not intended for sale other than in that package:

(c)

a container (other than an aerosol container) that—

(i)

contains a medicine or related product that is a gas; and

(ii)

is of a kind commonly used for storing or transporting gases in compressed, liquefied, or dissolved form; and

(iii)

has a capacity not exceeding 250 litres water capacity:

(d)

a container of a remedy that is, or is described as, homeopathic.

(2)

Nothing in regulation 13 or 14 applies to a strip of containers that—

(a)

is made of sheet material; and

(b)

bears the information required by—

(i)

regulation 13(1)(m) and (n) or regulation 14(1)(i) and (j) (as the case requires) at least once on the strip; and

(ii)

regulation 13(1)(a), (b), and (c) or regulation 14(1)(a), (b), and (c) (as the case requires)—

(A)

at least once in relation to every 2 containers, if the containers are easily detached from the strip; and

(B)

at least once on the strip in any other case; and

(c)

is contained in a package that complies with regulation 13 or 14 (as the case requires); and

(d)

is not intended for sale other than in that package.

(3)

In this regulation, strip of containers means a series of containers that each contain a single dose of a medicine or related product and that together form a strip.

(4)

Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a manufacturer or wholesaler, for the period of 3 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the manufacturer or wholesaler.

(5)

Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a retailer, for the period of 6 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the retailer.

(6)

For the purposes of subclauses (4) and (5), any goods purchased before the date on which a substance becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) for importation into New Zealand are deemed to be part of the purchaser’s stock-in-trade in New Zealand.

(7)

In any proceedings for an offence against section 44 of the Act in respect of any container that does not comply with regulation 13(1)(f), (g), or (h), the onus is on the defendant to prove that the relevant paragraph does not apply by virtue of subclause (4) or (5) of this regulation.

Regulation 15: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).