Commonwealth Numbered Regulations
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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:
- for an application to
which Division 3 of Part 5 of the Act applies the information
specified in Part 1 of Schedule 4;
- for an application to which Division 4 of Part 5 of the Act
applies the information specified in Part 2 of Schedule 4.
- 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.
- The information to be given in the application must be:
comprehensive as existing scientific knowledge, when the application is made,
- supported by whatever relevant data and references are available to the
- To the extent that compliance with paragraph (3) (b) does not provide
relevant data and references, the applicant must include in the application:
- a statement that specified information is incomplete or unavailable, as
the case may be; and
- 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
- a summary of known existing scientific evidence relevant to such
- 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.
At the commencement of the
Regulations, there is no fee payable for an application for a GMO licence
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