1Application and exemptions

1 Application and exemptions

1(1) This Order applies to those therapeutic goods that are medicines except goods:

(a) intended solely for use in animals;

(b) intended for use in the treatment of another person in accordance with paragraph 19(1)(a) of the Act or which are intended for other special access purposes specified in regulations 12A and 12B;

(c) intended for use solely for experimental purposes in humans;

(d) that fall within the description of Item 9(a) of Schedule 5 of the Regulations;

(e) that have not reached their final stage of manufacture;

(f) that are personal imports as described under Item 1 of Schedule 5 of the Regulations;

(g) that are medicinal gases;

(h) that are solely for export;

(i) made up or compounded in accordance with the individual prescription of a medical practitioner, dentist or veterinary surgeon by a pharmacist or by a person in the course of his or her employment by a pharmacist and under the actual personal supervision of that pharmacist;

(j) made up or compounded extemporaneously for a specific or individual case by a pharmacist in the lawful practice of his or her profession;

(k) supplied in the course of treating a patient or animal by a medical practitioner, dentist or veterinary surgeon in the lawful practice of his or her profession, other than professional starter packs;

(l) made up or compounded extemporaneously for a specific and individual case, in that person’s presence, by a complementary healthcare practitioner in the lawful practice of his or her profession.

1(2) Where transparent covering encloses or wraps a container or primary pack containing goods and the particulars which are required to be set out on the label of the container or on the primary pack are clearly visible through that transparent covering, the requirements of this Order do not apply to that transparent covering.