Therapeutic Goods (Charges) Act 1989

Act No. 22 of 1990 as amended

This compilation was prepared on 31 May 2011
taking into account amendments up to Act No. 53 of 2010

The text of any of those amendments not in force
on that date is appended in the Notes section

The operation of amendments that have been incorporated may be
affected by application provisions that are set out in the Notes section

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Contents

1............ Short title [see Note 1]........................................................................ 1

2............ Commencement................................................................................... 1

3............ Incorporation....................................................................................... 1

4............ Charges............................................................................................... 1

5............ Regulations......................................................................................... 3

Notes                                                                                                                                               5

An Act to impose an annual charge on the registration, listing and inclusion in the Register of therapeutic goods, and on the licensing of manufacturers of therapeutic goods

1  Short title [see Note 1]

                   This Act may be cited as the Therapeutic Goods (Charges) Act 1989.

2  Commencement

                   This Act commences on 1 July 1990.

3  Incorporation

             (1)  The Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with this Act.

          (1A)  For the purposes of this Act, if a suspension of the registration or listing of therapeutic goods has effect under Part 3‑2 of the Therapeutic Goods Act 1989, the goods are taken to be included in the Register under that Part.

          (1B)  For the purposes of this Act, if a suspension of a biological from the Register has effect under Part 3‑2A of the Therapeutic Goods Act 1989, the biological is taken to be included in the Register under that Part.

             (2)  For the purposes of this Act, if a suspension of a kind of medical device, or any medical devices of a particular kind, has effect under Chapter 4 of the Therapeutic Goods Act 1989, that kind of medical device is taken to be included in the Register under that Chapter.

4  Charges

             (1)  Annual charges of such amounts as are prescribed are payable in respect of the registration or listing of therapeutic goods, other than grouped therapeutic goods, that is in force at any time during a financial year.

          (1A)  If the registration or listing of one or more grouped therapeutic goods, being goods covered by a single registration or listing number, is in force at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the registrations or listings concerned.

       (1AA)  An annual charge of such amount as is prescribed is payable in respect of the inclusion of a biological in the Register under Part 3‑2A of the Therapeutic Goods Act that has effect at any time during a financial year.

          (1B)  Annual charges of such amounts as are prescribed are payable in respect of the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act that has effect at any time during a financial year.

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

Corresponding State laws

             (3)  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 registered goods, this section has effect as if the goods had been registered under Part 3‑2 of that Act.

             (4)  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 listed goods, this section has effect as if the goods had been listed under Part 3‑2 of that Act.

          (4A)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, a biological is included in the part of the Register for biologicals included under Part 3‑2A, this section has effect as if the biological had been included in the Register under Part 3‑2A of that Act.

             (5)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for medical devices included under Chapter 4, this section has effect as if the goods had been included in the Register under Chapter 4 of that Act.

             (6)  If:

                     (a)  because of the operation of section 6AAA, 6AAB or 6AAC of the Therapeutic Goods Act, the Secretary issues a licence; and

                     (b)  the licence is issued for the purposes of provisions of a corresponding State law that correspond to Part 3‑3 of the Therapeutic Goods Act;

this section has effect as if the licence had been issued under Part 3‑3 of that Act.

Definitions

             (7)  In this section:

amount includes a nil amount.

Therapeutic Goods Act means the Therapeutic Goods Act 1989.

5  Regulations

             (1)  The Governor‑General may make regulations, not inconsistent with this Act, prescribing the amounts of charges.

             (2)  The regulations may prescribe different charges in relation to:

                     (a)  different classes of goods (including medical devices); or

                     (b)  in the case of annual licensing charges—different steps in the manufacture of goods.

Notes to the Therapeutic Goods (Charges) Act 1989

Note 1

The Therapeutic Goods (Charges) Act 1989 as shown in this compilation comprises Act No. 22, 1990 amended as indicated in the Tables below.

All relevant information pertaining to application, saving or transitional provisions prior to 3 October 2008 is not included in this compilation. For subsequent information see Table A.

Table of Acts

Table of Amendments

Table A

Application, saving or transitional provisions

Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 (No. 96, 2008)

Schedule 1

6  Saving

Despite the repeal of subsection 5(3) of the Therapeutic Goods (Charges) Act 1989 made by this Act, that subsection continues to apply after the commencement of this item in relation to working out whether the annual charges mentioned in that subsection are payable by persons for the financial year beginning on 1 July 2008 and all earlier financial years.