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whole of this instrument 12 May 2023. 12 May 2023 Note: This table relates only to the provisions of this instrument as originally made.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; (c) Secretary; (d) sponsor. In this instrument: Act means the Therapeutic Goods Act 1989. adverse event means an adverse event that occurs in relation to a person in Australia following the administration of a medicine or biological. Note: An adverse event may not necessarily have a causal relationship with the administration of the medicine or biological. AEMS means the Adverse Event Management System maintained by the Therapeutic Goods Administration. product name, for a medicine or biological, means either: (a) the commercial name: (i) given to the medicine or biological by the sponsor or manufacturer; and (ii) under which the medicine or biological is supplied; or (b) the name recorded in the AEMS for the medicine or biological by the Therapeutic Goods Administration. Therapeutic Goods Administration, or TGA, means the part of the Department known as the Therapeutic Goods Administration. therapeutic goods information has the meaning given by subsection 61(1) of the Act. 5 Release of therapeutic goods information For subsection 61(5AA) of the Act, in relation to each item in the table in Schedule 1, the kinds of therapeutic goods information specified in column 2 may be released to a person, body or authority (or kinds of persons, bodies or authorities) specified in column 3, for the purposes specified in column 4. Note: Under subsection 61(5AA) of the Act, the Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose. Schedule 1—Therapeutic goods information Note: See section 5. Therapeutic goods information that may be released Column 1 Column 2 Column 3 Column 4 Item Kinds of information Persons or bodies Purposes 1 de-identified information contained in an adverse event report in relation to a medicine or biological (the relevant goods) that is recorded in the AEMS, where the adverse event report includes the product name of the relevant goods the sponsor (and persons authorised to act on behalf of the sponsor) of the relevant goods to assist the sponsor in satisfying pharmacovigilance obligations under the Act, by facilitating access to, and effective analysis of, data relating to safety issues associated with the relevant goods, in order to ensure the safe use of those goods 2 de-identified information contained in an adverse event report in relation to a medicine or biological that is recorded in the AEMS, where the adverse event report: a sponsor (and persons authorised to act on behalf of a sponsor) of a medicine or biological that contains the relevant active ingredient to assist the sponsor in satisfying pharmacovigilance obligations under the Act, by facilitating access to, and effective analysis of, data relating to safety issues associated with a medicine or biological that contains the relevant active ingredient, in order to ensure the safe use of those goods (a) includes the active ingredient of the medicine or biological (the relevant active ingredient); and (b) does not include the product name of the medicine or biological