Commonwealth Numbered Regulations Commonwealth Numbered RegulationsPart 1 -- Procedure for amending the current Poisons Standard
Therapeutic Goods Regulations 1990
1 Regulation 42ZCZI (definition of second closing date )
Omit "paragraph 42ZCZP(c)", substitute "paragraph 42ZCZP(1)(c)".
2 Regulation 42ZCZP
Omit "As soon", substitute "(1) As soon".
3 Paragraph 42ZCZP(c)
Repeal the paragraph, substitute:
(c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date ); and
4 At the end of regulation 42ZCZP
Add:
(2) The second closing date must be at least 10 business days after publication of the notice.
Part 2 -- Delegation under the Act
Therapeutic Goods (Medical Devices) Regulations 2002
5 Paragraph 10.6A(c)
Repeal the paragraph, substitute:
(c) Chief Medical Adviser, Health Products Regulation Group;
(d) each position classified as Medical Officer Class 5, Health Products Regulation Group.
Therapeutic Goods Regulations 1990
6 Paragraph 46A(2)(c)
Repeal the paragraph, substitute:
(c) Chief Medical Adviser, Health Products Regulation Group;
(d) each position classified as Medical Officer Class 5, Health Products Regulation Group.
Part 3 -- Supply of unapproved therapeutic goods
Therapeutic Goods (Medical Devices) Regulations 2002
7 Subparagraph 7.2(1)(b)(ii)
Repeal the subparagraph, substitute:
(ii) a statement in relation to the person is completed in accordance with subregulation (1A);
8 After subregulation 7.2(1)
Insert:
(1A) For the purposes of subparagraph (1)(b)(ii), a statement in relation to the use of an exempt device in or on a person who is a Category A patient must:
(a) be completed by:
(i) the medical practitioner by whom, or at whose direction, the device is used; or
(ii) by a health practitioner acting on behalf of that medical practitioner; and
(b) be in the form approved by the Secretary for the purposes of this paragraph; and
(c) include the following:
(i) the initial letters of the person's given name and surname, and the person's date of birth and sex;
(ii) the diagnosis of the person's condition;
(iii) the expected duration of the treatment;
(iv) a description of the exempt device;
(v) the supplier of the exempt device;
(vi) the number of units of the exempt device to be supplied;
(vii) the treating medical practitioner's name, practising address and other contact details; and
(d) include a statement to the effect that:
(i) the person is a Category A patient; and
(ii) the person, or the person's guardian, has given informed consent to the use of the device in or on the person.
(1B) An approval of a form referred to in paragraph (1A)(b) may require information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(1C) A person commits an offence of strict liability if the person:
(a) completes a statement referred to in subparagraph (1)(b)(ii); and
(b) does not send a copy of the statement to the Secretary within 28 days after the use of the exempt device to which the statement relates.
Penalty: 10 penalty units.
9 Regulation 8.2
Repeal the regulation.
10 In the appropriate position in Part 11
Insert:
In this Division:
"Amendment Regulations " means the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 .
"commencement day " means the day on which Part 3 of Schedule 4 to the Amendment Regulations commences.
11.33 Application--statements in relation to exempt devices
The amendments of regulations 7.2 and 8.2 of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to the use of a medical device in or on a person on or after the commencement day.
Therapeutic Goods Regulations 1990
11 Subparagraph 12A(2)(a)(iii)
Repeal the subparagraph, substitute:
(iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and
12 After subregulation 12A(2)
Insert:
(2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
13 Subregulation 12A(3)
Omit "signs a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological to be", substitute "completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is".
14 In the appropriate position in Part 9
Insert:
In this Division:
"Amendment Regulations " means the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 .
"commencement day " means the day on which Part 3 of Schedule 4 to the Amendment Regulations commences.
58 Application--statements in relation to unapproved medicines and biologicals
The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.
59 Transitional--approval of form for statements
(1) This regulation applies to the approval of a form if:
(a) the approval was made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations; and
(b) the approval was in force immediately before the commencement day.
(2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.
Therapeutic Goods Regulations 1990
15 Schedule 5 (table item 6)
Repeal the item, substitute:
6 | medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person, other than medicines that are used for gene therapy |
16 Schedule 5A (table item 5, column 2, paragraph (a))
Repeal the paragraph, substitute:
(a) the goods are not:
(i) biologicals; or
(ii) goods referred to in item 3; and
17 Schedule 8 (table item 2, column 3, paragraph (a))
Repeal the paragraph, substitute:
(a) the goods are not biologicals; and