Federal Register of Legislation
Therapeutic Goods Legislation Amendment (Copyright) Act 2011
No. 39, 2011
An Act to amend the Copyright Act 1968, and for related purposes
Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Amendments Copyright Act 1968
Therapeutic Goods Legislation Amendment (Copyright) Act 2011 No. 39, 2011
An Act to amend the Copyright Act 1968, and for related purposes
[Assented to 27 May 2011]
The Parliament of Australia enacts:
1 Short title This Act may be cited as the Therapeutic Goods Legislation Amendment (Copyright) Act 2011.
2 Commencement This Act commences on the day after this Act receives the Royal Assent.
3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
Schedule 1—Amendments
Copyright Act 1968
1 After section 44B Insert:
44BA Acts done in relation to certain medicine (1) The following acts are not an infringement of any copyright subsisting under this Part in a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine: (a) an act that is done under that Act and that is in respect of product information in relation to: (i) restricted medicine; or (ii) medicine in respect of which the applicant for the registration of that medicine under that Act has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii) of that Act; or (iii) medicine in respect of which subsection 25AA(2) or (3) of that Act applies; (b) an act that is ancillary or incidental to an act referred to in paragraph (a). (2) The following acts are not an infringement of any copyright subsisting under this Part in a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine: (a) supplying, in Australia, some or all of any product information that is approved under that section in relation to medicine; (b) reproducing, in Australia, some or all of the information referred to in paragraph (a); (c) publishing, in Australia, some or all of the information referred to in paragraph (a); (d) communicating, in Australia, some or all of the information referred to in paragraph (a); (e) adapting, in Australia, some or all of the information referred to in paragraph (a); to the extent that the supply, reproduction, publication, communication or adaptation is for a purpose related to the safe and effective use of the medicine referred to in paragraph (a). (3) An act done in Australia that is ancillary or incidental to a supply, reproduction, publication, communication or adaptation referred to in subsection (2) is not an infringement of any copyright subsisting under this Part in the work referred to in subsection (2). (4) For the purposes of this section, medicine, product information and restricted medicine have the same meanings as in the Therapeutic Goods Act 1989.
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