Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:
(a) it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death, serious illness or serious injury; or
(b) the goods become exempt goods; or
(c) the person requests in writing the cancellation of the registration or listing; or
(d) the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901 ; or
(da) the person has refused or failed to comply with the condition to which the inclusion of the goods is subject under paragraph 28(5)(d):
(i) if the person was requested under that paragraph to make the record in question available at or before a requested time--before the end of the period of 24 hours after that time; or
(ii) if the person was requested under that paragraph to make the record in question available immediately--within 24 hours after the request was made; or
(e) in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(a), (ca), (cb), (e), (fba), (fd), (fe) or (g) are incorrect or (if applicable) the requirements under subsection 26A(3) or (4A) are not fulfilled; or
(ea) in the case of a medicine listed under section 26AE, it appears to the Secretary that any of the certifications under paragraph 26AB(2)(a), (d), (e), (h) or (n) are incorrect or (if applicable) the requirements under subsection 26AB(4) or (6) are not fulfilled; or
(f) the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the goods and the Secretary is satisfied that the contravention is significant; or
(fa) if the person is a body corporate--a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the goods and the Secretary is satisfied that the contravention is significant; or
(fb) there is a breach, involving the goods, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under Part 5 - 1 or under the regulations, and the Secretary is satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the goods is misleading to a significant extent; or
(g) the Secretary is satisfied that a statement made in, or in connection with, the application for registration or listing of the goods was false or misleading in a material particular; or
(h) the annual registration or listing charge is not paid within 28 days after it becomes payable.
(1AA) Paragraph (1)(fb) does not apply to medicines that are manufactured in Australia for export only, or are imported into Australia for export only.
(1A) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A or 26AE, cancel the listing of the medicine if:
(a) the medicine is not eligible for listing; or
(1C) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:
(a) the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and
(b) the notice is given for the purposes of ascertaining whether any of the certifications by the person under subsection 26A(2) or (2A) in relation to the medicine are incorrect; and
(c) the person fails to comply with the notice within 20 working days after the notice is given.
(1D) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26AE, cancel the listing of the medicine if:
(a) the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and
(b) the notice is given for the purposes of ascertaining whether any of the certifications by the person under subsection 26AB(2) or (3) in relation to the medicine are incorrect; and
(c) the person fails to comply with the notice within 20 working days after the notice is given.
(2) Subject to subsection (3), the Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:
(a) it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable; or
(aa) it appears to the Secretary that the presentation of the goods:
(i) in the case of registered goods--is not acceptable; or
(ii) in the case of listed goods--is unacceptable; or
(b) the goods have changed so that they have become separate and distinct from the goods as so included; or
(ba) in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(b), (c), (d), (da), (f), (fa), (fb), (fc), (h), (i), (j), (ja) or (k) or subsection 26A(2A) are incorrect; or
(bab) in the case of a medicine listed under section 26AE, it appears to the Secretary that any of the certifications under paragraph 26AB(2)(b), (c), (f), (g), (i), (j), (k), (l), (m), (o), (p) or (q) or subsection 26AB(3) are incorrect; or
(c) the sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (other than the condition under paragraph 28(5)(d)); or
(caa) all of the following subparagraphs apply:
(i) the Secretary gives the person a notice under section 31 that requires the person to give to the Secretary information, or to produce to the Secretary documents, relating to the goods;
(ii) subsection (1C) of this section does not apply to the notice;
(iii) the person fails to comply with that notice within a further 14 days after the end of the period specified in that notice; or
(ca) the person has contravened subsection 29A(1) or 29AA(1) in relation to the goods; or
(d) the goods become required to be included in the other part of the Register; or
(e) the goods do not conform to a standard applicable to the goods; or
(eaa) the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the goods; or
(eab) if the person is a body corporate--a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the goods; or
(ea) either of the following has not been complied with in relation to the goods:
(i) an applicable provision of the Therapeutic Goods Advertising Code;
(ii) any other requirement relating to advertising applicable under Part 5 - 1 or the regulations.
(3) Where the Secretary proposes to cancel the registration or listing of goods in relation to a person under subsection (2), the Secretary must:
(a) inform the person in writing that the Secretary proposes to cancel that registration or listing and set out the reasons for that proposed action; and
(b) give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed action.
(4) Where a person makes submissions in accordance with paragraph (3)(b), the Secretary is not to make a decision relating to the cancellation until the Secretary has taken the submissions into account.
(4A) The Secretary must, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration of the goods if the Secretary becomes aware that protected information was used when evaluating the goods for registration.
(4B) The Secretary must, by notice in writing given to a person in relation to whom a medicine is listed under section 26AE, cancel the listing of the medicine if the Secretary becomes aware that restricted information was used when evaluating the medicine for listing.
(4C) The Secretary must, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if the Secretary is satisfied that:
(a) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--imports into Australia, exports from Australia or supplies in Australia of the goods would contravene one or more of those prohibitions; or
(b) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--imports into Australia, exports from Australia or supplies in Australia of the goods would contravene one or more of those conditions.
(5) Where the Secretary cancels the registration or listing of goods in relation to a person, the goods cease to be registered or listed:
(a) if the cancellation is effected under subsection (1), (1A), (1C), (1D) or (4C)--on the day on which the notice of cancellation is given to the person; or
(b) in any other case--on the day specified in the notice, which
must be at least 20 working days after the notice is given to the person.