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THERAPEUTIC GOODS ACT 1989 - SECT 41HC

Authorities for health practitioners

             (1)  The Secretary may authorise, in writing, a specified medical practitioner to supply specified kinds of medical devices for use in the treatment of humans to a specified class of recipients.

          (1A)  An application for an authority under subsection (1) must be in a form (if any) approved, in writing, by the Secretary.

             (2)  An authority under subsection (1) may be given subject to conditions specified in the authority.

             (3)  The Secretary may impose conditions (or further conditions) on the authority given to a person under subsection (1) by giving the person written notice of the conditions.

             (4)  An authority under subsection (1) may only be given:

                     (a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

                     (b)  to a medical practitioner who has the approval of an ethics committee to supply the specified kinds of medical devices or the specified class of such devices; and

                     (c)  in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.

However, the regulations may prescribe circumstances in which paragraph (b) does not apply.

             (5)  The regulations may prescribe circumstances in which medical devices may be supplied under an authority under subsection (1).

             (6)  The Minister may, by legislative instrument, make rules authorising any health practitioner who is included in a specified class of health practitioners to supply a specified kind of medical device, for use in the treatment of humans, to the class or classes of recipients specified in those rules, so long as:

                     (a)  that kind of medical device is supplied in the circumstances specified in those rules; and

                     (b)  the conditions (if any) specified in those rules are satisfied.

          (6A)  In making rules under subsection (6), the Minister must comply with:

                     (a)  such requirements (if any) as are prescribed by the regulations; and

                     (b)  such restrictions (if any) as are prescribed by the regulations; and

                     (c)  such limitations (if any) as are prescribed by the regulations.

          (6B)  If:

                     (a)  a person is authorised, by subsection (6) rules, to supply a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind in accordance with those rules;

the person must:

                     (c)  notify the supply to the Secretary; and

                     (d)  do so within 28 days after the supply.

          (6C)  A notification under subsection (6B) must:

                     (a)  be in accordance with a form that is approved, in writing, by the Secretary; and

                     (b)  contain such information as is prescribed by the regulations.

          (6D)  An approval of a form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

          (6E)  A person commits an offence if:

                     (a)  the person is subject to a requirement under subsection (6B); and

                     (b)  the person omits to do an act; and

                     (c)  the omission breaches the requirement.

Penalty:  10 penalty units.

           (6F)  An offence against subsection (6E) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

        (6FA)  Subsection (6E) does not apply in relation to a person and a requirement to notify a supply of a medical device if a health practitioner, on behalf of the person, does the following:

                     (a)  notifies the supply to the Secretary within 28 days after the supply;

                     (b)  makes the notification in accordance with the requirements referred to in subsection (6C).

Note:          A defendant bears an evidential burden in relation to the matter in subsection (6FA): see subsection 13.3(3) of the Criminal Code .

          (6G)  In recommending to the Governor-General that regulations should be made for the purposes of paragraph (6C)(b), the Minister must have regard to the principle that information should only be prescribed for the purposes of that paragraph if the information is reasonably required for the responsible scrutiny by the Secretary of the operation of the scheme embodied in subsection (6).

             (7)  In this section:

"medical practitioner" means a person who is registered, in a State or internal Territory, as a medical practitioner.



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