Agricultural Compounds and Veterinary Medicines Act 1997

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)

refuse to grant 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, grant the application and 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 grant an application 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 grant an application without the consent of the Director-General of Health if the trade name product to which it relates is a prescription medicine within the meaning of section 3 of the Medicines Act 1981.

(5)

The Director-General must not grant an application if—

(a)

the trade name product to which it relates contains an agricultural compound that is also a hazardous substance or new organism; and

(b)

an approval for that substance or organism has not been issued under the Hazardous Substances and New Organisms Act 1996.

Section 21(1)(c): amended, on 8 November 2016, by section 10 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).

Section 21(1)(d): amended, on 8 November 2016, by section 10 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).

Section 21(2): amended, on 8 November 2016, by section 10 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).

Section 21(4): replaced, on 8 November 2016, by section 10 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).

Section 21(5): replaced, on 8 November 2016, by section 10 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).