Commonwealth Numbered Regulations Commonwealth Numbered Regulations
Therapeutic Goods (Medical Devices) Regulations 2002
1 Regulation 7.7
Omit "section 41HC", substitute "subsection 41HC(1)".
2 At the end of Division 7.3 of Part 7
Add:
7.8 Information to be notified in relation to supply of certain medical devices
For the purposes of paragraph 41HC(6C)(b) of the Act, the information that must be contained in a notification under subsection 41HC(6B) of the Act in relation to the supply by a health practitioner of a medical device to a person is as follows:
(a) the person's initials, date of birth and gender;
(b) each medical condition in relation to which the device was supplied;
(c) each intended use of the device in relation to which the device was supplied;
(d) the product name of the device;
(e) the name of the manufacturer of the device;
(f) a brief description of the device including whether the device is a variant;
(g) the practitioner's name, AHPRA number and contact details;
(h) the health profession in which the practitioner is registered or licensed to practise;
(i) the address of the practitioner's principal place of practice.
3 Subregulation 8.2(2)
Omit "20 working days after signing it", substitute "28 days after the use of the exempt device to which the statement relates".
4 Subclause 8(3) of Schedule 3A (paragraph (c) of the definition of authorised person )
Omit "section 41HC", substitute "subsection 41HC(1)".
5 Subclause 8(3) of Schedule 3A (at the end of the definition of authorised person )
Add:
; or (d) for an authority given by rules made under subsection 41HC(6) of the Act--a health practitioner included in the class of health practitioners specified in the rules.
6 Dictionary
Insert:
"AHPRA number " , of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
Therapeutic Goods Regulations 1990
7 Regulation 2
Insert:
"AHPRA number " , of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
8 Subregulation 12A(3)
After "subparagraph (2)(a)(iii)", insert "in relation to a medicine or biological to be given to a person".
9 Subregulation 12A(3)
Omit "4 weeks of signing it", substitute "28 days after the medicine or biological is given to the person".
10 Regulation 12B (heading)
Repeal the heading, substitute:
12B Exemptions for certain uses--medicines and therapeutic devices
11 At the end of regulation 12B
Add:
(5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.
(6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:
(a) the person's initials, date of birth and gender;
(b) each medical condition in relation to which the medicine was supplied;
(c) each indication of the medicine in relation to which the medicine was supplied;
(d) each active ingredient of the medicine;
(e) the dosage form of the medicine;
(f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine--information about the release mechanism;
(g) if the route of administration of the medicine was clinically relevant to the supply of the medicine--information about the route of administration;
(h) the practitioner's name, AHPRA number and contact details;
(i) the health profession in which the practitioner is registered or licensed to practise;
(j) the address of the practitioner's principal place of practice.
12 Regulation 12C (heading)
Repeal the heading, substitute:
12C Exemptions for health practitioners--biologicals
13 At the end of regulation 12C
Add:
(5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:
(a) the person's initials, date of birth and gender;
(b) each medical condition in relation to which the biological was supplied;
(c) each indication of the biological in relation to which the biological was supplied;
(d) a description of the biological, including the following:
(i) the product name of the biological;
(ii) each active ingredient of the biological;
(iii) the route of administration of the biological;
(e) the practitioner's name, AHPRA number and contact details;
(f) the health profession in which the practitioner is registered or licensed to practise;
(g) the address of the practitioner's principal place of practice.
14 Paragraph 47B(1)(c)
Omit "a person (a sponsor ) to whom", substitute "a sponsor of therapeutic goods in relation to which".
15 Paragraph 47B(5)(b)
Omit "medical", substitute "health".
16 At the end of paragraph 47B(5)(b)
Add:
; and (v) to which rules made under subsection 19(7A), 32CM(7A) or 41HC(6) of the Act apply.
17 Schedule 5A (table item 1, column 2, after paragraph (c))
Insert:
(ca) authorised for supply under rules made under subsection 19(7A) or 32CM(7A) of the Act; or
18 Subclause 8(3) of Schedule 5B (paragraph (b) of the definition of authorised person )
Omit "or authority under section 19, 32CK or 32CM of the Act", substitute "under subsection 19(1) or section 32CK of the Act, or the authority under subsection 19(5) or 32CM(1) of the Act,".
19 Subclause 8(3) of Schedule 5B (after paragraph (b) of the definition of authorised person )
Insert:
(ba) who is included in a class of health practitioners specified in rules made under subsection 19(7A) or 32CM(7A) of the Act; or