38Application for manufacture permit—information requirements

38 Application for manufacture permit—information requirements

(1) For the purposes of paragraph 12(2)(a) of the Act, the information specified in this section is prescribed in relation to an application by the holder of a manufacture licence (the applicant) for a manufacture permit. (2) The application must contain the following information: (a) the name of the applicant; (b) the licence number of the manufacture licence held by the applicant; (c) details of the narcotic drug proposed to be manufactured; (d) details of the proposed end use of the manufactured drugs;

Note: End use may, for example, include export, use in research, supply for clinical trials, manufacture of other drugs or supply to patients in accordance with State or Territory laws.

(e) details of the starting materials to be used, the source of the starting materials and the amounts of the starting materials required, to manufacture the narcotic drug;
(f) details of the maximum quantities of the narcotic drug that is to be manufactured;
(g) details of the maximum quantities of the narcotic drug that, in the opinion of the applicant, having regard to prevailing market conditions, it will be necessary for the applicant to have in the applicant’s possession or control at any time for the normal conduct of business;
(h) the period during which the narcotic drug is to be manufactured;
(i) the period for which the permit is proposed to be in force.