Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021 (Cth)

Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021

I, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following specification.

Dated 4 August 2021

Adjunct Professor John Skerritt Deputy Secretary Health Products Regulation Group Department of Health

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Release of therapeutic goods information Schedule 1—Specified kinds of therapeutic goods information

1 Name This instrument is the Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021.

2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument The day after this instrument is registered.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.

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.