New Zealand Legislation: Acts

21 Decision on application

• (1) The Director-General must consider any application made under section 9 and must—

  • (a) Identify the risks and benefits likely to result from the manufacture and use of the trade name product, and any known practicable alternative methods of managing those risks; and

  • (b) Evaluate the likely risks and benefits of each alternative method identified in accordance with paragraph (a); and

  • (c) Decline the application if, in the opinion of the Director-General,—

    • (i) The risks likely to result from the use of that product cannot be sufficiently reduced by imposing conditions on the registration of the trade name product; or

    • (ii) Insufficient information is available to assess the risks likely to result from the use of the trade name product; or

  • (d) In every other case, register the trade name product without conditions, or with the conditions imposed in accordance with section 23 that the Director-General, after taking into account the costs of those conditions, considers will—

    • (i) Manage the risks from the use of the product; and

    • (ii) Impose the least cost on the public.

  (2) The decision to register a trade name product may provide—

  • (a) That the registration expires upon a fixed date; or

  • (b) That the registration expires when the purpose of the registration has been achieved.

  (3) Subject to the provisions of Part 6, the Director-General must give the decision in writing, with reasons, to the applicant and to every person who made a submission.

  (4) The Director-General must not register a trade name product under this section without the consent of the Director-General of Health if that product is a prescription medicine within the meaning of section 3 of the Medicines Act 1981.

  (5) Where a trade name product contains an agricultural compound that is also a hazardous substance or new organism, the Director-General must not register that product under this section, unless an approval for that substance or organism has been issued under the Hazardous Substances and New Organisms Act 1996.