Section 7C instruments

The following instruments are made under section 7C of the Therapeutic Goods Act 1989.

• Therapeutic Goods (Database of Adverse Event Notifications) (Arrangement for Computer Programs) Instrument 2023
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under subsection 61(5C) of the Act to release information of a kind specified in an instrument made under subsection 61(5D) relating to the Database of Adverse Event Notifications (DAEN).
• Therapeutic Goods (Adverse Event Management System - Sponsors) (Arrangement for Computer Programs) Instrument 2023
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to release de-identified adverse event information to sponsors relevant to their therapeutic goods.
• Therapeutic Goods (System for Australian Recall Actions) (Arrangement for Computer Programs) Instrument 2023
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under subsection 61(5C) of the Act to release information of a kind specified in an instrument made under subsection 61(5D) relating to the System for Australian Recall Actions (SARA).
• Therapeutic Goods (Adverse Events Management System - Adverse Events Following Immunisation) (Arrangement for Computer Programs) Instrument 2022
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act.
• Therapeutic Goods (Medical Devices - Arrangement for Computer Programs) Instrument 2020
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 41FDB, 41FF and 41FH of the Act.

• Instrument of arrangement: Use of computer program to make decisions, July 2018
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 (the Act) for the use of computer programs to make decisions under the Act and the Therapeutic Goods Regulations 1990 relating to the cancellation of entries on the Australian Register of Therapeutic Goods (ARTG), the revocation of cancelled ARTG entries, and the transfer or assignment of business.

• Instrument of arrangement: Use of computer program to make decisions, November 2017
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under paragraph 61(2)(a)(iii) of the Act to release information from the Adverse Event Management System to the World Health Organization.
• Instrument of arrangement: Use of computer programs to make decisions, July 2017
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for the use of computer program to make decisions under subsection 9D(2C) and paragraph 9D(1)(b).
• Instrument of arrangement: Use of computer programs to make decisions, September 2016
  Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for the use of computer program to make decisions in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.