THERAPEUTIC GOODS ACT 1989 - SECT 28 Conditions of registration or listing
THERAPEUTIC GOODS ACT 1989 - SECT 28
Conditions of registration or listing(1) The registration or listing of therapeutic goods is subject to the conditions set out in a determination under subsection (2).
(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1), being conditions that relate to:
(a) the manufacture of the goods; or
(b) the custody, use, supply, disposal or destruction of the goods; or
(c) the keeping of records relating to the goods; or
(d) matters dealt with in, or matters additional to matters dealt with in, standards applicable to the goods; or
(e) such other matters relating to the goods as the Minister thinks appropriate.
(2A) Without limiting subsection (2), different conditions may be specified for:
(a) the registration of therapeutic goods; and
(aa) the provisional registration of medicine; and
(b) the listing of therapeutic goods; and
(c) different classes of therapeutic goods.
(2AA) Despite subsection 14(2) of the Legislation Act 2003 , a determination under subsection (2) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
(2B) If the Secretary includes therapeutic goods in the Register in relation to a person, the Secretary may, by notice in writing given to the person, impose conditions on the registration or listing of those goods.
(3) The Secretary may, by notice in writing given to the person in relation to whom therapeutic goods are registered or listed, impose new conditions on the registration or listing or vary or remove conditions imposed under subsection (2B) or this subsection.
(3A) The Secretary's power under subsection (3) may be exercised at the request of the person concerned or of the Secretary's own motion. A request must be accompanied by the prescribed fee.
(4) The imposition or variation or removal of a condition under subsection (3) takes effect:
(a) if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury--on the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or
(b) in any other case--on the day specified for the purpose in the notice, being a day not earlier than 28 days after the notice is given to the person.
(4A) For the purposes of paragraphs (4)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.
(5) In addition to any conditions imposed under subsection (1), (2B) or (3), the registration or listing of therapeutic goods (the subject goods ) is subject to the conditions that the person in relation to whom the subject goods are registered or listed will:
(i) the person proposes to make a change to the information included in the entry in the Register that relates to the subject goods; and
(ii) the information proposed to be changed is of a kind that relates to one or more of the matters referred to in paragraphs 25(1)(c) to (ja), 26(1)(c) to (n), 26A(2)(a) to (ja) or 26AB(2)(a) to (p) (as appropriate); and
(iii) the Secretary would be required, under section 9D, to vary that entry, or to consider whether to vary that entry, in relation to the information proposed to be changed if the person made a request under that section for a variation of that entry;
make that request and not make the change unless the Secretary varies that entry in accordance with that request; and
(aa) not supply a batch of the subject goods in Australia, or export a batch of the subject goods from Australia, after the expiry date for the goods; and
(ab) not, by any means, advertise the subject goods for an indication other than those accepted in relation to the inclusion of the goods in the Register; and
(a) allow an authorised person:
(i) to enter, at any reasonable time, premises at which the person deals with the subject goods, complies with record - keeping requirements covered by paragraph (c) or (ca), or keeps documents that relate to the subject goods; and
(ii) while on those premises, to inspect those premises and any therapeutic goods on those premises and to examine, take measurements of, conduct tests on or take samples of any therapeutic goods on those premises or any thing on those premises that relates to any therapeutic goods; and
(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and
(iv) while on those premises, to inspect, and make copies of, any records kept in compliance with paragraph (c) or (ca); and
(v) while on those premises, to inspect, and make copies of, any documents that relate to the subject goods; and
(b) if requested to do so by an authorised person, produce to the person such documents relating to the subject goods as the person requires and allow the person to copy the documents; and
(c) in relation to each batch of the subject goods--keep a record, at least until the end of the period of 12 months after the expiry date for the goods, of all of the manufacturers involved in the manufacture of that batch; and
(ca) comply, in relation to the subject goods, with any record - keeping requirements that are prescribed; and
(d) if requested to do so by an authorised person, make any record kept in compliance with paragraph (c) or (ca) available to the authorised person for inspection:
(i) at or before the time the authorised person requests, or (if the authorised person requests) immediately; and
(ii) either in electronic form or in paper form, as the authorised person requests; and
(e) comply, in relation to the subject goods, with any reporting requirements that are prescribed; and
(f) if a manufacturer who was not nominated as a manufacturer of the subject goods in the application for the registration or listing of the goods becomes a manufacturer of the goods--inform the Secretary in writing of that fact, no later than 10 working days after the manufacturer becomes a manufacturer of the goods; and
(g) if premises that were not nominated as premises to be used in the manufacture of the subject goods in the application become premises used in the manufacture of the goods--inform the Secretary in writing of that fact, no later than 10 working days after the premises are first used for that purpose; and
(h) deliver a reasonable number of samples of the subject goods if the Secretary so requests:
(i) within the period specified in the request (which must include at least 10 working days); and
(ii) in accordance with any other requirements specified in the request; and
(i) comply, in relation to the subject goods, with a notice given to the person under subsection 25AA(1B).
(5B) The listing of a medicine under section 26A or 26AE is subject to a condition that:
(a) each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3 - 3 in relation to that step; and
(b) each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3), 26AB(4) or 28A(2).
(5C) Subsection (5B) does not apply if the medicine is exempt from the operation of Part 3 - 3.
(6) If in, or in connection with, an application for the listing of therapeutic goods, a claim (other than a claim that is an indication) is made by the applicant in relation to the goods, the listing of the goods is subject to the following conditions:
(a) a condition that the sponsor of the goods had, at the time when the claim was made, information or evidence that supported the claim and complied with the requirements (if any) specified in a determination made under subsection 26A(2B);
(b) a condition that the sponsor retains the information or evidence at all times while the goods remain listed;
(c) a condition that, at any time while the goods remain listed, the sponsor will, if asked to do so by the Secretary, give the information or evidence to the Secretary.
(a) a medicine is listed under section 26A; and
(b) an indication is accepted in relation to the inclusion of the medicine in the Register;
the listing of the medicine is subject to the following conditions:
(c) a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication and complies with the requirements (if any) specified in a determination under subsection 26A(2B);
(d) a condition that, at any time while the medicine remains listed, the person will, if asked to do so by the Secretary, give the information or evidence to the Secretary.
(a) a medicine is listed under section 26AE; and
(b) an indication is accepted in relation to the inclusion of the medicine in the Register;
the listing of the medicine is subject to the following conditions:
(c) a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication;
(d) a condition that, at any time while the medicine remains
listed, the person will, if asked to do so by the Secretary, give the
information or evidence to the Secretary.