30 Exemption for clinical trial

(1)

Notwithstanding section 20 or section 24, but subject to the succeeding provisions of this section, the importer or manufacturer in New Zealand of any medicine may distribute it for the sole purpose of obtaining clinical and scientific information with respect to its safety and efficacy, if the clinical trial, and the persons (in this section called the investigators) who will conduct the trial, have been approved by the Director-General on the recommendation of the Health Research Council of New Zealand.

(2)

An application for the approval of the Director-General in respect of this section shall be made by the importer, manufacturer, or packer, or the intending manufacturer, packer, seller, or supplier, in New Zealand of the medicine, and shall—

(a)

be made in the prescribed manner (if any); and

(b)

be addressed to the Director-General; and

(c)

set out the true name of the applicant; and

(ca)

be accompanied by the prescribed fee; and

(d)

state, or be accompanied by a statement of, the particulars set out in subsection (3).

(3)

The particulars required by subsection (2)(d) are the following:

(a)

the nature of the medicine, its identifying name or mark, and its chemical formula:

(b)

the purpose of the trial:

(c)

the names and qualifications of the investigators who will conduct the trial, and their curricula vitae:

(d)

a written consent to nomination from each of the investigators:

(e)

a copy of the information supplied to the investigators, particularly in relation to the safe use of the medicine:

(f)

a protocol of the trial, setting out—

(i)

the number of patients to be involved; and

(ii)

the form that the trial is to take, and the nature of the records to be kept; and

(iii)

the persons or classes of persons (if any) who are to be specially excluded from the trial; and

(iv)

any special measures proposed to be taken to ensure the safety of the patients:

(g)

the names and addresses of the institutions or laboratories where the medicines will be used by approved persons, and a description of the facilities that will be available to those persons.

(4)

The Director-General shall determine every application for his approval under this section within 45 days after the receipt of the application, and shall notify the applicant of his decision and (where he declines the application) the reasons for his decision.

(5)

At any time after a clinical trial has been approved by the Director-General, the applicant may apply to the Director-General for the approval of an investigator, notwithstanding that the name of that person did not appear in the application for approval of the clinical trial; and paragraphs (a) to (c) of subsection (2), and paragraphs (c), (d), and (g) of subsection (3), shall apply in respect of every such application.

(6)

The Director-General may at any time, by notice in writing given to an applicant, require the applicant to supply such further information and particulars as he thinks fit relating to a clinical trial or to the identity and qualifications of an investigator.

(7)

The distribution of any medicine under this section shall be subject to the following conditions:

(a)

the Director-General shall be informed, before the medicine is so distributed, of the identifying name or mark by which it may be recognised:

(b)

every label on every package or container of the medicine shall bear the words “To be used by qualified investigators only”:

(c)

the importer or manufacturer shall, before so distributing the medicine, take all reasonable steps to ensure that every person to whom it is supplied is approved under this section as a person qualified to carry out, and has available the necessary facilities for, the trial to be conducted by him, and the medicine shall be used solely by that person or under his direction for the purposes of the trial:

(d)

the importer or manufacturer shall—

(i)

keep complete and accurate records of all quantities of the medicine supplied under this section:

(ii)

keep the Director-General informed of the progress of the trial by 6-monthly reports:

(iii)

supply to the Director-General a copy of the results of the trial on its completion.

(8)

The Director-General may at any time, by notice in writing to the applicant, revoke or suspend his approval of a clinical trial.

Compare: 1969 No 7 s 15

Section 30(1): amended, on 1 October 1990, by section 57 of the Health Research Council Act 1990 (1990 No 68).

Section 30(2)(ca): inserted, on 8 August 1990, by section 5 of the Medicines Amendment Act (No 2) 1990 (1990 No 97).