Commonwealth Coat of Arms of Australia

Therapeutic Goods (Charges) Amendment Act 2018

No. 8, 2018

An Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes

[Assented to 5 March 2018]

The Parliament of Australia enacts:

This Act is the Therapeutic Goods (Charges) Amendment Act 2018.

(1) Each provision of this Act 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. Sections 1 to 3 and anything in this Act not elsewhere covered by this table	The day this Act receives the Royal Assent.	5 March 2018
2. Schedule 1	At the same time as Schedule 5 to the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 commences. However, the provisions do not commence at all if that Schedule does not commence.	6 March 2018

Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.

(2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.

3 Schedules

Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1—Amendments

Therapeutic Goods (Charges) Act 1989

1 Title

Omit “and on the licensing of manufacturers of therapeutic goods”, substitute “, on the licensing of manufacturers of therapeutic goods and on the making of conformity assessment body determinations”.

2 At the end of subsection 3(1)

Add:

Note: Subsection (1) applies the interpretation provisions of the Therapeutic Goods Act 1989 (such as subsection 3(8) of that Act, which says a reference to the registration of therapeutic goods includes a reference to the provisional registration of a medicine).

3 At the end of section 3

Add:

(3) For the purposes of this Act, if a suspension of a conformity assessment body determination has effect under regulations made for the purposes of Part 4‑4A of the Therapeutic Goods Act 1989, the determination is taken to be in force for the period of the suspension.

4 At the end of subsection 4(1)

Add:

Note: The reference to registration of therapeutic goods includes a reference to the provisional registration of a medicine (see subsection 3(8) of the Therapeutic Goods Act 1989 as applied by subsection 3(1) of this Act).

5 After subsection 4(2)

Insert:

(2A) An annual charge of such amount as is prescribed is payable in respect of a conformity assessment body determination that is in force at any time during a financial year.

6 After subsection 4(3)

Insert:

(3A) If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as provisionally registered goods, this section has effect as if the goods had been registered under Part 3‑2 of that Act.

7 At the end of subsection 5(2)

Add:

; or (c) conformity assessment body determinations of different kinds.

8 Application provision

The amendments made by this Schedule apply in relation to the financial year in which this item commences and to each later financial year.

[Minister’s second reading speech made in—

House of Representatives on 14 September 2017

Senate on 4 December 2017]

(214/17)