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1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 12
12. Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)
12.1 Heading:
Omit "Regulation 12", substitute "Subregulation 12 (1)".
12.2 Item 5:
Omit the item.
12.3 Item 7, paragraph (c):
Omit the paragraph, substitute:
"(c) non-implantable, non-powered diagnostic tools that:
(i) are not supplied in a sterile state; and
(ii) are not intended to monitor a physiological process; and
(iii) are not referred to in paragraph (b)".
12.4 Item 10:
Omit the item.
12.5 Item 11:
Omit the item, substitute:
"11 therapeutic goods:
(a) in relation to the
importation of which a permission, licence or declaration under regulation 5A,
5B or 5C of the Customs (Pro-hibited Imports) Regulations granted or made
before the commencement of the Act is in force; and
(b) which are supplied in Australia for use in humans not more than 6
months after the commencement of the Act".
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