Therapeutic Goods (Prescription Medicines—Transparency Measures) Specification 2020 (Cth)

Therapeutic Goods (Prescription Medicines—Transparency Measures) Specification 2020

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

Dated 17 December 2020

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 (Prescription Medicines—Transparency Measures) Specification 2020.

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 1 January 2021. 1 January 2021

Note: This table relates only to the provisions of this instrument as originally made.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) indications; (b) medicine; (c) passed preliminary assessment; (d) registered goods; (e) Secretary; and (f) therapeutic goods. In this instrument: Act means the Therapeutic Goods Act 1989. new indications medicine has the same meaning as in the Regulations. new prescription medicine has the same meaning as in the Regulations. registered medicine means a medicine that is a registered good. Regulations means the Therapeutic Goods Regulations 1990. relevant medicine means a new prescription medicine or a new indications medicine, which is the subject of an application for registration under section 23 of the Act that has passed preliminary assessment, but does not include a medicine that is a biosimilar in relation to a registered medicine. therapeutic goods information has the meaning given by subsection 61(1) of the Act.