21Applications for Minister's consent

1. Every application for the Minister's consent under section 20 shall—

3. 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:
4. be addressed to the Director-General:
5. be accompanied by the prescribed fee:
6. state, or be accompanied by a statement of, the particulars specified in subsection (2).

7. The following particulars are required:

8. the business address of the person in whose name the application is made:
9. the name under which the medicine will be distributed:
10. details of the method of manufacture of the medicine:
11. qualitative and quantitative particulars of all ingredients of the medicine named by the descriptive or non-proprietary names of the ingredients:
12. a description of the quality of the raw materials used in the manufacture of the medicine:
13. a description of the form or forms of the medicine, the dosage, and the method and route of administration:
14. the indications for which the medicine may be administered:
15. reports of toxicological, pharmacological, and clinical studies that support the application:
16. reports of any tests made to control or monitor the quality of the medicine, including any tests that relate to its stability:
17. a translation into English, authenticated in a manner required in writing by the Director-General, of any report referred to in paragraph (h) or (i) that is not in English:
18. 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:
19. an accurate copy of every label and other descriptive matter proposed to be used on or included in, or to accompany, packages or containers containing the medicine:
20. the name and address of the place or places where the manufacture, preparation, or packing is intended to be carried out.

21. 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.

22. 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—

23. such samples of the medicine; and
24. 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.

25. 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.