Document ID: chunk:federal_register_of_legislation:C2016A00012:clause:1_11k
Version: federal_register_of_legislation:C2016A00012
Segment Type: clause
Provision Reference: sch 1 cl 11K
Character Range: 80034–82216

11K  Particular rules about manufacture licences involving cannabis etc.

Application of section
 (1) This section applies to an application for a manufacture licence that will authorise the manufacture of a drug that includes, or is from, any part of the cannabis plant.

Particular circumstances in which Secretary must refuse to grant a manufacture licence
 (2) The Secretary must refuse to grant the licence if the Secretary is not satisfied on reasonable grounds of one of the following:
 (a) in the case of any such drug (including, but not limited to, a drug that is a medicinal cannabis product)—that the drug is for the purposes of research in relation to medicinal cannabis products, and the applicant:
 (i) has the appropriate financial resources, other resources and expertise that are necessary to carry out such research; or
 (ii) is included in a class of persons prescribed by the regulations;
 (b) that the drug is a medicinal cannabis product that will be:
 (i) supplied for the purposes of use in a clinical trial that is, or is likely to be, approved under the Therapeutic Goods Act 1989 or notified to the Secretary under that Act; or
 (ii) otherwise supplied in accordance with an approval or authority under the Therapeutic Goods Act 1989; or
 (iii) supplied in circumstances prescribed by the regulations;
 (c) that the drug is a medicinal cannabis product that is registered goods within the meaning of the Therapeutic Goods Act 1989.

Special rule in exceptional circumstances
 (3) Paragraph 11J(1)(b) does not prevent the Secretary from granting the licence if the Secretary is satisfied that:
 (a) the conduct referred to in that paragraph:
 (i) constitutes a serious offence solely because it involves the cultivation or obtaining of the cannabis plant, or the production or supply of cannabis or cannabis resin or of products containing cannabis or cannabis resin; and
 (ii) was fully disclosed in the application; and
 (b) if the licence were granted, the applicant could comply with all the requirements of the licence and this Act.
However, this subsection does not require the Secretary to grant the licence even if the Secretary is so satisfied.