Therapeutic Goods Regulations 1990

This regulation applies in relation to a person who is liable to pay:

an annual registration charge for registered goods that are medicines; or

an annual charge for inclusion in the Register for a financial year of:

a biological; or

a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or

an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.

The person may apply to the Secretary, in writing, for the charge to be waived for a financial year.

An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:

be made:

if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and

in any other case—at any time during the relevant financial year; and

be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).

No application fee is payable.

A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:

to waive the charge for the financial year; or

to refuse to waive the charge for the financial year.

In considering the application, the Secretary:

must take into account the information referred to in paragraph (3)(b); and

must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.

Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.

The Secretary may decide to waive the charge for a financial year only if the Secretary is satisfied that:

the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and

it is in the interest of public health for the entry in relation to the goods to remain on the Register; and

it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.

For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:

the population who use the goods;

the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;

any health risks to the population who use the goods that may be associated with:

obtaining the goods through alternative means; or

the use of alternative goods;

the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.

The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).

As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.

If the decision is to refuse to waive the charge for the financial year, the notice under subregulation (10) must:

set out the reasons for the decision; and

specify the date on which the charge for the financial year becomes payable.

If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.

If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.