4Charges

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.

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).

(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. (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. 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. (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. (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: