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;
(h) the conformity of the goods to a requirement relating to advertising applicable under Part 5-1 or under 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;
(j) the regulatory history of the goods in another country;
(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 23(1)(a); 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 medicine--the matters covered by a certification by the person under paragraph 26A(2)(j) in relation to the medicine;
(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, or to a requirement relating to advertising applicable to the goods under Part 5-1 or under 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;
(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.
Penalty: 500 penalty units.
(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 .
(5) An offence under subsection (4) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
(5A) A person commits an offence if:
(a) a medicine is listed under section 26A in relation to the person; and
(b) the person provides information in purported compliance with a notice under section 31 relating to the medicine; and
(c) the information is false or misleading in a material particular; and
(d) either:
(i) the use of the medicine has resulted in, or will result in, harm or injury to any person; or
(ii) the use of the medicine, if the medicine were used, would result in harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: 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.
(5B) A person commits an offence if:
(a) a medicine is listed under section 26A in relation to the person; and
(b) the person provides information in purported compliance with a notice under section 31 relating to the medicine; and
(c) the information is false or misleading in a material particular; and
(d) the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
(5C) Subsection (5B) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
(6) A person in relation to whom a medicine is listed under section 26A must not, in purported compliance with a notice under this section relating to the medicine, provide information that is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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