Document ID: chunk:federal_register_of_legislation:F2021L01087:clause:1_4
Version: federal_register_of_legislation:F2021L01087
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 1605–3867

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) current Poisons Standard;
(b) health practitioner;
(c) indications;
(d) Secretary.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
authorised prescriber application means an application for an authority under subsection 19(5) of the Act.
Note: Subsection 19(5) of the Act provides that the Secretary may authorise a medical practitioner to supply specified therapeutic goods for use in the treatment of humans, or a specified class of such goods, to a class or classes of recipients specified in the authority.
authorised prescriber report means a report provided to the Secretary in accordance with regulation 47B of the Regulations by a person authorised under subsection 19(5) of the Act.
medical practitioner has the same meaning as in subsection 19(9) of the Act.
medicinal cannabis products has the same meaning as in the Regulations.
Regulations means the Therapeutic Goods Regulations 1990.
relevant product means a medicinal cannabis product that is the subject of one of the following:
 (a) an authorised prescriber application;
 (b) an authorised prescriber report;
 (c) a SAS A notification;
 (d) a SAS B application.
SAS A notification means a statement referred to in subparagraph 12A(2)(a)(iii) of the Regulations that is sent to the Secretary in accordance with subregulation 12A(3) of the Regulations.
Note: Regulation 12A is made for the purposes of subsection 18(1) of the Act, and exempts certain medicines for use in life-threatening cases from the operation of Part 3-2A of the Act.
SAS B application means an application made in accordance with subsection 19(2) of the Act for an approval under paragraph 19(1)(a) of the Act.
Note: Paragraph 19(1)(a) of the Act provides that the Secretary may grant an approval for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods, listed goods or exempt goods for use in the treatment of another person.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.