Medicines Regulations 1984

13 Labelling of medicines

(1)

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

(a)

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

(b)

the name of each active ingredient:

(c)

the appropriate quantitative particulars of each active ingredient:

(d)

a description of the medicine, including dose form, or presentation, that indicates the true nature of the medicine:

(e)

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

(f)

in the case of a prescription medicine,—

(i)

the words “PRESCRIPTION MEDICINE” or words of a similar meaning; or

(ii)

the words “PRESCRIPTION-ONLY MEDICINE” or words of a similar meaning; or

(iii)

the acronym “POM”:

(g)

in the case of a restricted medicine,—

(i)

the words “RESTRICTED MEDICINE”; or

(ii)

the words “PHARMACIST-ONLY MEDICINE”:

(h)

in the case of a pharmacy-only medicine,—

(i)

the words “PHARMACY-ONLY MEDICINE” or words of a similar meaning; or

(ii)

the words “PHARMACY MEDICINE” or words of a similar meaning:

(i)

any warning statement required by these regulations for the medicine:

(j)

in the case of a medicine other than a prescription medicine, a statement of the purpose for which the medicine is intended to be used:

(k)

in the case of a medicine 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:

(l)

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

(i)

the dose recommended; and

(ii)

the frequency of that dose:

(m)

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 medicine:

(n)

the words “Use by” or “Use before”, or words of a similar meaning, followed by the expiry date (being in no case later than 5 years after the date of manufacture of the medicine) appropriate to the stability of the medicine:

(o)

where appropriate, a statement of the recommended storage conditions:

(p)

the name and address of—

(i)

the manufacturer or seller of the medicine; 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)(p),—

(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 medicine 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.

(3)

In the case of a medicine intended for administration only in accordance with the directions of a practitioner, it is sufficient compliance with subclause (1)(l) to indicate the dose by a range if the container is accompanied by a more specific statement relating to each usage.

(4)

In the case of a prescription medicine, compliance with the requirements of subclause (1)(k) or (l) is required only at the time at which that medicine—

(a)

is sold by retail; or

(b)

is supplied in circumstances corresponding to retail sale; or

(c)

is supplied by way of gift or sample for the purpose of promoting a sale.

(5)

Subclause (1)(l) does not apply in the case of a medicine intended to be administered by or under the supervision of a practitioner, in circumstances where the dosage is to be dependent on concurrent skilled observation.

(6)

Every container of a medicine that is prepared for injection into the human body and that contains an antiseptic or preservative must be labelled with a statement of the nature and amount of the antiseptic or preservative.

(7)

Every container of a medicine that is a biochemical preparation must, in addition to the other requirements in this regulation, bear a label containing the following:

(a)

a statement of the potency of the preparation; and

(b)

a statement of the nature and amount of every antiseptic or preservative (if any) used in the medicine.

(8)

Where it is impractical to put all of the information required by this regulation on a label because the container is too small, it is sufficient compliance with this regulation to print the information required by subclause (1)(i), (j), and (o) on a separate information sheet, in the same manner as that information would be required by these regulations to be printed on a label, and to supply that sheet to the customer with the medicine.

(9)

This regulation is subject to regulations 15 and 23.

Regulation 13: substituted, on 1 August 2011, by regulation 8 of the Medicines Amendment Regulations 2011 (SR 2011/245).