Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 7

                   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.