Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 7

Prescribed goods for advertising offence and civil penalty

    For the purposes of subsections   42DL(12) and 42DLB(9) of the Act, the therapeutic goods are the following:

  (a)   therapeutic goods that are the subject of an approval or authority under section   19 of the Act;

  (b)   a medical device, or a kind of medical device, that is the subject of an approval under section   41HB of the Act or an authority under section   41HC of the Act;

  (c)   medicines covered by an exemption under subregulation   12A(1);

  (d)   therapeutic goods specified in item   1 of Schedule   5;

  (e)   therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule   5A;

  (f)   a kind of medical device mentioned in item   1.1 in Part   1 of Schedule   4 to the Therapeutic Goods (Medical Devices) Regulations   2002 ;

  (g)   a kind of medical device mentioned in column 2 of an item in Part   2 of Schedule   4 to the Therapeutic Goods (Medical Devices) Regulations   2002 (except items   2.12, 2.13, 2.14 and 2.15 of that Part);

  (h)   a kind of medical device covered by an exemption under regulation   7.2 of the Therapeutic Goods (Medical Devices) Regulations   2002 ;

  (i)   therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;

  (j)   therapeutic goods that:

  (i)   are, or contain, a substance that is included in Schedule   3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and

  (ii)   are extemporaneously compounded for a particular person for therapeutic application to that person.


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