Document ID: chunk:federal_register_of_legislation:C2004A04631:body:0:p12
Version: federal_register_of_legislation:C2004A04631
Segment Type: other
Provision Reference: 
Character Range: 28668–31592

provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 4 of this Act.";

     (c) by omitting from subsection (3) "include the goods in the list" and substituting "list the goods";

     (d) by omitting from subsection (4) "the therapeutic goods in respect of which the application" and substituting "therapeutic goods in respect of which an application".

Conditions of registration or listing

39. Section 28 of the Principal Act is amended by omitting subsection (6).

Secretary may require information

40. Section 31 of the Principal Act is amended by adding at the end the following subsections:

"(4) A person in relation to whom therapeutic goods are registered or listed must not, without reasonable excuse, fail to comply with a notice given to the person under this section.

Penalty: 60 penalty units.

"(5) A person in relation to whom therapeutic goods are registered or listed must not, in purported compliance with a notice under this section, knowingly or recklessly provide information that is false or misleading in a material particular.

Penalty: 60 penalty units.".

Inspection and variation of entries in Register

  41.(1) Section 32 of the Principal Act is amended:

  (a) by omitting subsection (2);

  (b) by omitting subsection (5) and substituting the following subsection:

      "(5) Where:

        (a) the person in relation to whom therapeutic goods are registered or listed has asked the Secretary to vary information included in the entry in the Register that relates to the goods; and

      (b) subsection (4) does not apply to the request; and

        (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;

     the Secretary may vary the entry in accordance with the request.".

(2) Regulations in force for the purposes of subsection 32(2) of the Principal Act immediately before the commencement of this section have effect, after that commencement, as if they had been made under section 63 of the Principal Act as amended by this Act.

Application for licence

42. Section 37 of the Principal Act is amended by omitting from paragraph (1)(c) "premises" and substituting "manufacturing premises".

Grant of licence

43. Section 38 of the Principal Act is amended by omitting from paragraph (1)(a) "premises" and substituting "manufacturing premises".

Conditions of licences

44. Section 40 of the Principal Act is amended by omitting from subparagraph (4)(b)(i) "premises" and substituting "manufacturing premises".

Publication of list of manufacturers etc.

45. Section 42 of the Principal Act is amended by omitting "premises" and substituting "manufacturing premises".

Entry and search of premises—evidence of offences

46. Section 47 of