Section 1 - Therapeutic Goods (Adverse Event Management System—Sponsors) (Information) Specification 2023 - Therapeutic Goods (Adverse Event Management System—Sponsors) (Information) Specification 2023

1Therapeutic Goods (Adverse Event Management System—Sponsors) (Information) Specification 2023

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Commonwealth Coat of Arms of Australia

Therapeutic Goods (Adverse Event Management System—Sponsors) (Information) Specification 2023

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

Dated 5 May 2023

Nicholas Henderson

Acting First Assistant Secretary

Medicines Regulation Division

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

Schedule 1—Therapeutic goods information

1 Name

This instrument is the Therapeutic Goods (Adverse Event Management System—Sponsors) (Information) Specification 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 12 May 2023. 12 May 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Note: This table relates only to the provisions of this instrument as originally made.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 subsection 61(5AB) 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) biological;

(b) medicine;