Medicines Act 1981

21 Applications for Minister’s consent

(1)

Every application for the Minister’s consent under section 20 shall—

(a)
[Repealed]

(b)

be made in the true name of the manufacturer or importer or proprietor, or the proposed manufacturer or importer or proprietor, in New Zealand of the medicine, by that person or by his duly authorised agent:

(c)

be addressed to the Director-General:

(ca)

be accompanied by the prescribed fee:

(d)

state, or be accompanied by a statement of, the particulars specified in subsection (2).

(2)

The particulars required by subsection (1)(d) are the following:

(a)

the business address of the person in whose name the application is made, and, where that person is not the manufacturer of the medicine and of each of the principal ingredients of the medicine, the true name and business address of each such manufacturer:

(b)

the name under which the medicine will be distributed:

(c)

details of the method of manufacture of the medicine:

(d)

a full statement of the ingredients named by the descriptive or non-proprietary names of the medicine, including details of the quantities in which they are present:

(e)

a description of the quality of the raw materials used in the manufacture of the medicine:

(f)

a description of the form or forms of the medicine:

(g)

the proposed or recommended dosage and frequency of dose, and the manner in which the medicine will be recommended to be administered, applied, or otherwise used:

(h)

the purposes for which the medicine will be recommended to be used, and the claims or representations to be made in respect of its usefulness:

(i)

reports of any tests made to establish the safety of the medicine for the purposes for which and in the manner in which it is intended to be used:

(j)

reports of any tests made to control the strength, quality, purity, or safety of the medicine and of the method of testing:

(k)

any reports relating to the efficacy of the medicine:

(l)

a translation into English, authenticated in such manner as the Director-General may require, of any report referred to in paragraph (i) or paragraph (j) or paragraph (k) that is not in English:

(m)

any evidence to show that the distribution in any country other than New Zealand of the medicine in the form and for the purposes that it is proposed to be distributed in New Zealand has been approved or consented to by the appropriate authorities in that country:

(n)

the intended method of distribution of the medicine in New Zealand:

(o)

a coloured specimen of every label and other descriptive matter proposed to be used on or included in, or to accompany, packages or containers containing the medicine:

(p)

the name and address of the place or places where the manufacture, preparation, or packing is intended to be carried out.

(3)

Notwithstanding anything in subsection (1), in the case of a medicine to which section 20 applies by virtue of subsection (1) of that section, the notice deposited with the Director-General under section 24 shall, subject to subsections (4) and (5), be a sufficient application for the consent of the Minister under the said section 20.

(4)

At any time before the publication of a notice signifying the consent of the Minister to the distribution of a medicine in respect of which an application under section 20 has been made, the Director-General may, by notice in writing given to the person in whose name the application was made, require that person to supply—

(a)

such samples of the medicine; and

(b)

such further information or particulars concerning the medicine, or the manufacture, intended sale, distribution, or advertising of the medicine,—

as the Director-General may specify in his notice.

(5)

The Director-General may, if he thinks fit, require any person to verify by statutory declaration any statement in an application made, or in any further information or particulars supplied, under this section and signed by that person.

Compare: 1969 No 7 s 13

Section 21(1)(a): repealed (without coming into force), on 8 March 1985, by section 2 of the Medicines Amendment Act 1985 (1985 No 29).

Section 21(1)(ca): inserted, on 8 August 1990, by section 2 of the Medicines Amendment Act (No 2) 1990 (1990 No 97).

Section 21(4): amended, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).