19Approvals or authorities for certain uses

#### 19 Approvals or authorities for certain uses (1) The Secretary may, by notice in writing, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods or listed goods: (a) for use in the treatment of another person; or (b) for use solely for experimental purposes in humans; and such an approval may be given subject to such conditions as are specified in the notice of approval. > Note: For variation of an approval for use of the kind referred to in paragraph (1)(b), see subsection (4B). (1AA) An approval for use of the kind referred to in paragraph (1)(a) must not be granted to a person unless the person is a health practitioner. (1A) An approval mentioned in paragraph (1)(a) or (b) is subject to the conditions (if any) specified in the regulations for the purposes of that paragraph. Those conditions (if any) are in addition to any conditions imposed on the approval under subsection (1). (2) An application for an approval must be made to the Secretary and must: (a) in the case of an application for use of the kind referred to in paragraph (1)(a)—be in a form (if any) approved, in writing, by the Secretary and be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and (b) in the case of an application for use of the kind referred to in paragraph (1)(b): (i) be in a form (if any) approved, in writing, by the Secretary; and (ii) be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and (iii) be accompanied by the prescribed evaluation fee. (3) Without limiting the conditions to which an approval under subsection (1) may be made subject, those conditions may include a condition relating to the charges that may be made for the therapeutic goods to which the approval relates. (4) Where an application for an approval is made, the Secretary must, after having considered the application and, in the case of an application for the use of therapeutic goods for experimental purposes in humans, after having evaluated the information submitted with the application, notify the applicant of the decision on the application within 28 days of making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision. (4A) The use by a person for experimental purposes in humans of specified therapeutic goods that are the subject of an approval granted to someone else under paragraph (1)(b) is subject to the conditions (if any) specified in the regulations relating to one or more of the following: (a) the preconditions on the use of the goods for those purposes; (b) the principles to be followed in the use of the goods for those purposes; (c) the monitoring of the use, and the results of the use, of the goods for those purposes; (d) the circumstances in which the person must cease the use of the goods for those purposes. (4B) If: (a) the Secretary grants an approval to a person under subsection (1) for use of the kind referred to in paragraph (1)(b); and (b) the person requests the Secretary to do either or both of the following: (i) vary the therapeutic goods specified in the approval; (ii) vary the conditions imposed under subsection (1) on the approval; and (c) the request is in a form (if any) approved, in writing, by the Secretary; and (d) the request is accompanied by such information relating to the therapeutic goods as is required by the Secretary; and (e) the request is accompanied by the fee prescribed by the regulations; the Secretary must, by notice in writing, vary or refuse to vary the approval. Any variation may be different than the variation requested and may involve imposing new conditions on the approval or varying or removing existing conditions. (4C) The Secretary must notify the person making the request under subsection (4B) of: (a) the Secretary’s decision on the request; and (b) for a decision to vary the approval in a way that is different than the variation requested or a decision to refuse to vary the approval—the reasons for the decision. (4D) A variation under subsection (4B) takes effect at the time the Secretary notifies the person under subsection (4C) of the variation. (5) The Secretary may, in writing, authorise a specified medical practitioner to supply: (a) specified therapeutic goods for use in the treatment of humans; or (b) a specified class of such goods; to the class or classes of recipients specified in the authority. (5AA) An application for an authority under subsection (5) must be in a form (if any) approved, in writing, by the Secretary. (5A) An authority may be given subject to the conditions (if any) specified in the authority. (5B) The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions). (6) An authority under subsection (5) 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 (aa) to a medical practitioner who has the approval of an ethics committee to supply the specified therapeutic goods or the specified class of such goods; and (b) in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph. Paragraph (aa) does not apply in the circumstances (if any) prescribed by the regulations for the purposes of this subsection. (7) The regulations may prescribe the circumstances in which therapeutic goods may be supplied under an authority under subsection (5). (7A) 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 therapeutic goods for use in the treatment of humans; or (b) a specified class of such goods; to the class or classes of recipients specified in those rules, so long as: (c) the goods are supplied in the circumstances specified in those rules; and (d) the conditions (if any) specified in those rules are satisfied. (7B) In making rules under subsection (7A), 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. (7C) If: (a) a person is authorised, by subsection (7A) rules, to supply therapeutic goods; and (b) the person supplies those goods 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. (7D) A notification under subsection (7C) 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. (7E) 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. (7F) A person commits an offence if: (a) the person is subject to a requirement under subsection (7C); and (b) the person omits to do an act; and (c) the omission breaches the requirement. Penalty: 10 penalty units. (7G) An offence against subsection (7F) is an offence of strict liability. > Note: For strict liability, see section 6.1 of the Criminal Code. (7GA) Subsection (7F) does not apply in relation to a person and a requirement to notify a supply of therapeutic goods 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 (7D). > Note: A defendant bears an evidential burden in relation to the matter in subsection (7GA): see subsection 13.3(3) of the Criminal Code. (7H) In recommending to the Governor‑General that regulations should be made for the purposes of paragraph (7D)(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 (7A). (8) The regulations may prescribe the circumstances in which an approval under paragraph (1)(a), or an authority under subsection (5), must not be given, including but not limited to, circumstances relating to the following: (a) therapeutic goods included in a specified class; (b) therapeutic goods when used in the treatment of a specified class of persons; (c) therapeutic goods when used for a particular indication.