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GENE TECHNOLOGY REGULATIONS 2001 2001 No. 106 - REG 7

Application for licence — prescribed information

(1) For paragraph 40 (2) (a) of the Act, the following information must be contained in an application for a licence:

(a)
for an application to which Division 3 of Part 5 of the Act applies — the information specified in Part 1 of Schedule 4;

(b)
for an application to which Division 4 of Part 5 of the Act applies — the information specified in Part 2 of Schedule 4.

(2)
In preparing that information, an applicant must take account of risks that the proposed dealing, or dealings, with a GMO may incur in relation to the health and safety of people and the environment.

(3)
The information to be given in the application must be:

(a)
as comprehensive as existing scientific knowledge, when the application is made, permits; and

(b)
supported by whatever relevant data and references are available to the applicant.

(4)
To the extent that compliance with paragraph (3) (b) does not provide relevant data and references, the applicant must include in the application:

(a)
a statement that specified information is incomplete or unavailable, as the case may be; and

(b)
an indication of the significance of the incomplete or unavailable information to the evaluation of the possible risks of the proposal in relation to the health and safety of people and the environment; and

(c)
a summary of known existing scientific evidence relevant to such evaluation; and

(d)
applying that summary — an evaluation of the possible risks based on theoretical approaches, and research methods, that are generally accepted in the scientific community.

Note 1    Additional information, specified in writing by the Regulator, may also be required.
Note 2
At the commencement of the Regulations, there is no fee payable for an application for a GMO licence



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