Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025

I, Nicholas Henderson, as delegate of the Secretary of the Department of Health and Aged Care, make the following determination.

Dated 6 March 2025

Nicholas Henderson

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments

Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

1  Name

  This instrument is the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025.

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.

Note: This table relates only to the provisions of this instrument as originally made.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.

1.     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 23B(10) of the Therapeutic Goods Act 1989.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

1  Section 4 (definition of eCTD)

Repeal the definition, substitute:

  eCTD means the electronic Common Technical Document standard format, including:

 (a) Module 1 in accordance with eCTD AU module 1 and regional information v3.2, as in force or existing on 1 April 2025; and

 (b) Modules 2 to 5 in accordance with ICH eCTD Specification v3.2.2, as in force or existing on 1 April 2025.

Note: The eCTD AU module 1 and regulation information v3.2 is published by the TGA on the TGA website at www.tga.gov.au. The ICH eCTD Specification v3.2.2. is published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and is available at www.ich.org.

2  After section 6

Insert:

7  Application, savings and transitional provisions

  This instrument, as in force immediately before the amendments made by the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025, continues to apply to applications for registration made before 1 October 2025.