Commonwealth Numbered Regulations

1994 No. 150 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 15

15.1 Paragraph 1 (b): After "Act", insert ", or are insulin preparations".

15.2 Paragraph 1 (c): Omit the paragraph, substitute:

"(c) in the case of other drugs:

        (i)    the quantity imported in one importation is not more than 3
               months supply at the maximum dose recommended by the
               manufacturer; and

        (ii)   the total quantity of the drug imported for use in the
               treatment of the importer or the importer's immediate family in
               the period of 12 months ending on the day on which the latest
               importation occurs does not exceed 15 months supply of the drug
               at the maximum dose recommended by the manufacturer; or the
               drugs have been approved, or are included in a class of drugs
               that has been approved, under regulation 5 of the Customs
               (Prohibited Imports) Regulations for importation into
               Australia; and".

15.3 Item 6: Omit the item, substitute:

"5 custom-made therapeutic devices that are produced for a particular person
for therapeutic application to that person, other than the following goods:

   (a)  therapeutic devices referred to in item 3 of Part 1 of Schedule 3;

   (b)  therapeutic devices referred to in an item in Part 2 of Schedule 3;

   (c)  electronic devices that must be programmed for each patient using
        those devices

"6 drugs that are dispensed, or extemporaneously compounded, for a particular
person for therapeutic application to that person".

15.4 Paragraph 7 (b): Add at the end of the item:

"(v) containers of a kind referred to in paragraph 7 (l) ; or".

15.5 Paragraph 7 (f): Omit the paragraph, substitute:

"(f) therapeutic devices for dental use that are:

        (i)    constructed externally to the mouth; and

        (ii)   fitted or fixed into the mouth on a temporary or permanent
               basis; and

        (iii)  intended for protection, or to correct an irregularity or
               deficiency; other than the following:

        (iv)   devices of human or animal origin;

        (v)    dental restorative materials;

        (vi)   devices that, when used, are implanted directly into bone or
               soft tissue;

        (vii)  therapeutic devices for dental use included in an item in
               Schedule 3 or 4; or

   (fa) therapeutic devices for dental use that are dental impression
        materials; or".

15.6 Paragraph 7 (l): Omit the paragraph, substitute:

"(l) containers other than:

        (i)    syringes; or

        (ii)   single use containers designed for the collection, directly
               from a person, of blood for diagnostic testing; or

        (iii)  containers designed for the collection of blood for
               transfusion; or

        (iv)   containers designed for the collection of blood for use in the
               manufacture of blood products; or

        (v)    containers designed for the storage of blood and blood
               components for parenteral administration; or

        (vi)   containers, not made of glass, designed for the storage and
               parenteral administration of therapeutic goods (commonly
               referred to as 'large volume parenteral infusion bags') ; or

        (vii)  bags designed for the collection of fluids drained from the
               body of a patient (commonly referred to as 'drainage bags') ;
               or".

15.7 Paragraph 8 (g): Omit the paragraph, substitute:

"(g) sunscreen preparations for dermal use that:

        (i)    are packaged in containers the labels of which include a
               statement that the preparations have a sun protection factor
               below 4 or the equivalent category description; and

        (ii)   when tested as described in Joint Standard AS/NZS 2604:1993,
               published by Standards Australia, as in force from time to
               time, are established to have a sun protection factor below 4
               or the equivalent category description".

15.8 Add at the end:

"12 allergens for skin patch testing on unbroken skin, whether or not the
allergen is also described in an item in Schedule 3 or 4".