Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023 (Cth)

Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023

I, Anthony Lawler, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated 25 September 2023

Professor Anthony Lawler Deputy Secretary Health Products Regulation Group Department of Health and Aged Care

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Release of therapeutic goods information 6 Repeals Schedule 1—Therapeutic goods information Part 1—DAEN – Medical Devices Part 2—DAEN – Medicines Schedule 2—Repeals Therapeutic Goods (Database of Adverse Event Notifications) (Information) Specification 2022 Therapeutic Goods Information (Adverse Event Notifications – Medical Devices) Specification 2013 Therapeutic Goods Information (Joint Recalls Portal) Specification 2013

1 Name This instrument is the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023.

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 30 September 2023. 30 September 2023

Note: This table relates only to the provisions of this instrument as originally made.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 section 61(5D) of the Therapeutic Goods Act 1989.