Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Secretary may, by notice in writing given to a person:
(aa) who is an applicant for the registration of therapeutic goods; or
(ab) in relation to whom therapeutic goods are registered; or
(ac) in relation to whom therapeutic goods were, at any time during the previous 5 years, registered;
require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(d) the quality of the goods;
(e) the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;
(f) the presentation of the goods;
(g) the safety and efficacy of the goods for the purposes for which they are to be used;
(ga) whether the goods comply with conditions (if any) on the registration of the goods;
(gb) the conformity of the goods to a standard applicable to the goods;
(h) whether 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 5 - 1A or the regulations;
(ha) if the goods are registered in relation to the person--whether the goods are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(hb) if the goods are registered in relation to the person and there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--whether any supplies in Australia, any imports into Australia or any exports from Australia of the goods contravene those prohibitions;
(hc) if the goods are registered in relation to the person and there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--whether any supplies in Australia, any imports into Australia or any exports from Australia of the goods contravene those conditions;
(j) the regulatory history of the goods in another country;
(ja) if the goods are a reportable medicine and the medicine is registered in relation to the person:
(i) whether or not there is a shortage of the medicine in Australia; or
(ii) if there is a shortage of the medicine in Australia--the shortage; or
(iii) any decision of the person to permanently discontinue the supply of the medicine in Australia;
(k) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.
(1A) If a notice is given under subsection (1) to a person covered by paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were registered.
(1B) If:
(a) a person makes an application under section 23 for the registration of therapeutic goods in accordance with a form referred to in paragraph 23B(2)(a); and
(aa) the application has passed preliminary assessment; and
(b) the form is described as a pre - submission planning form; and
(c) the person chooses a number of days specified in the form for the purposes of giving information or documents to the Secretary in the event that the person is given a notice under subsection (1) of this section in relation to the application;
then that number of days must be specified in any such notice as the time within which the person must give the required information or documents to the Secretary. The number of days so specified is taken to be a reasonable time for the purposes of subsection (1).
(1C) If:
(a) the person in relation to whom therapeutic goods are registered makes a request under subsection 9D(3) in accordance with a form referred to in subsection 9D(6); and
(b) the form is described as a pre - submission planning form; and
(c) the person chooses a number of days specified in the form for the purposes of giving information or documents to the Secretary in the event that the person is given a notice under subsection (1) of this section in relation to the request;
then that number of days must be specified in any such notice as the time within which the person must give the required information or documents to the Secretary. The number of days so specified is taken to be a reasonable time for the purposes of subsection (1).
(2) The Secretary may, by notice in writing given to a person:
(aa) who is an applicant for the listing of therapeutic goods; or
(ab) in relation to whom therapeutic goods are listed; or
(ac) in relation to whom therapeutic goods were, at any time during the previous 5 years, listed;
require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(ca) the quality of the goods;
(d) the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;
(e) the presentation of the goods;
(f) the safety of the goods for the purposes for which they are to be used;
(fa) if the goods are listed under section 26A--any of the matters covered by a certification by the person under subsection 26A(2) or (2A) in relation to the medicine;
(fab) if the goods are or were listed under section 26AE--any of the matters covered by a certification by the person under subsection 26AB(2) or (3) in relation to the medicine;
(fac) if the goods are or were listed under section 26AE--the efficacy of the goods in relation to the purposes for which they are to be used;
(fb) whether the goods comply with conditions (if any) on the listing of the goods;
(g) the conformity of the goods to a standard applicable to the goods;
(gaa) whether 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 5 - 1A or the regulations;
(ga) if the goods are listed in relation to the person--whether the goods are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(gb) if the goods are listed in relation to the person and there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--whether any supplies in Australia, any imports into Australia or any exports from Australia of the goods contravene those prohibitions;
(gc) if the goods are listed in relation to the person and there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--whether any supplies in Australia, any imports into Australia or any exports from Australia of the goods contravene those conditions;
(h) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.
(2A) If a notice is given under subsection (2) to a person covered by paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were listed.
(3) 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.
(4) A person commits an offence if:
(a) either:
(i) the person is given a notice under subsection (1) and the person is covered by paragraph (1)(ab) or (ac); or
(ii) the person is given a notice under subsection (2) and the person is covered by paragraph (2)(ab) or (ac); and
(b) the person fails to comply with the notice.
(4A) Subsection (4) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4A). See subsection 13.3(3) of the Criminal Code .
(4B) A person commits an offence if:
(a) either:
(i) the person is given a notice under subsection (1) and the person is covered by paragraph (1)(ab) or (ac); or
(ii) the person is given a notice under subsection (2) and the person is covered by paragraph (2)(ab) or (ac); and
(b) the person fails to comply with the notice.
(5) An offence against subsection (4B) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
(5AA) Subsection (4B) does not apply if the person has a reasonable excuse.
Note: A defendant bears an evidential burden in relation to the matter in subsection (5AA): see subsection 13.3(3) of the Criminal Code .
(5A) A person commits an offence if:
(a) the person is given a notice under this section in relation to therapeutic goods; and
(b) the person gives information or a document in compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a material particular; and
(d) either:
(i) the use of the therapeutic goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
(ii) the use of the therapeutic goods, if the therapeutic goods were used, would result in, or would be likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (6) instead: see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(6) A person commits an offence if:
(a) the person is given a notice under this section in relation to therapeutic goods; and
(b) the person gives information or a document in compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(7) A person commits an offence if:
(a) the person is given a notice under this section in relation to therapeutic goods; and
(b) the person gives information or a document in compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a material particular.
(8) An offence against subsection (7) is an offence of strict liability.