Commonwealth Numbered Regulations Commonwealth Numbered RegulationsNote: See subregulation 9A(1A).
A consumer medicine information document about a medicine must:
(a) be written in English; and
(b) be clearly legible; and
(c) be written in language that will easily be understood by patients; and
(d) be consistent with product information about the product.
2 Specific requirements--document enclosed within packaging etc.
Also, if the consumer medicine information document about a medicine is enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine, it must set out all of the information required by the "TGA Consumer Medicine Information (Non-prescription Medicine) Template" (published by the Therapeutic Goods Administration on its website) but:
(a) it is not required to set out the information in the same order as the Template; and
(b) it is not required to include any Consumer Medicine Information (CMI) summary that forms part of that Template.
3 Specific requirements--document not enclosed within packaging etc.
Also, if the consumer medicine information document about a medicine is not enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine:
(a) it must set out all of the information required by the "TGA Consumer Medicine Information (Non-prescription Medicine) Template" (published by the Therapeutic Goods Administration on its website) in the same order as the Template; and
(b) if it is supplied in electronic form, it must be in the form of a PDF file or an HTML file.
Schedule 7 -- Handling and testing of samples
Therapeutic Goods Regulations 1990
1 Regulation 2 (definition of official analyst )
Repeal the definition.
2 Subregulation 23(1)
Insert:
"analyst " means a person appointed by the Secretary as an analyst (except an official analyst) under regulation 25.
"appropriately fastened and sealed " : see subregulation (2).
"official analyst " means a person appointed by the Secretary as an official analyst under regulation 25.
3 Subregulation 23(1) (definition of relevant test )
Repeal the definition.
4 Subregulation 23(1) (definition of responsible analyst )
After "means an", insert "analyst or".
5 Subregulation 23(2)
Repeal the subregulation, substitute:
(2) For the purposes of this Part, a sample of therapeutic goods is appropriately fastened and sealed if the sample is fastened and sealed:
(a) in a container or package that is marked with a unique identification number or with the name and address of:
(i) the person from whom the sample was taken; or
(ii) for a sample delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act--the sponsor of the goods; and
(b) so as to prevent the opening of the container or package, and the removal of the unique identification number or the name and address, without breaking the seal.
6 Regulation 25 (heading)
Repeal the heading, substitute:
25 Appointment of analysts and official analysts and powers of official analysts
7 Subregulation 25(1)
After "to be an", insert "analyst or an".
8 Subregulation 25(2)
Repeal the subregulation.
9 Paragraph 25(3)(c)
After "nominate an", insert "analyst or".
10 At the end of regulation 25
Add:
(4) The tests determined under paragraph (3)(b), by an official analyst, for the following matters must be tests covered by regulation 28:
(a) determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods;
(b) determining whether a particular kind of medical device complies with the applicable provisions of the essential principles.
(5) The tests determined under paragraph (3)(b), by an official analyst, for a matter not covered by subregulation (4), are the tests that the official analyst considers appropriate.
11 Paragraph 26(2)(a)
Omit "packaged,".
12 Paragraph 26A(1)(a)
Omit "packaged,".
13 Subparagraphs 26A(1)(b)(i) and (ii)
Omit "packaged," (wherever occurring).
14 Paragraphs 27(1)(a) and (b)
Omit "packaged,".
15 Paragraph 27(2)(a)
Omit "relevant tests to the extent the analyst considers necessary", substitute "performing the tests determined under paragraph 25(3)(b) in relation to the sample".
16 At the end of paragraph 27(2)(a)
Add:
(iii) for a sample of medicine listed under section 26A or 26AE of the Act--whether the medicine contains an ingredient that is not specified in a determination under paragraph 26BB(1)(a) of the Act or whether any of the requirements determined under paragraph 26BB(1)(b) of the Act have been contravened; and
17 Regulation 28 (heading)
Repeal the heading, substitute:
28 Tests for determining conformity with a standard or compliance with essential principles
18 Subregulation 28(1)
Omit "relevant".
19 Paragraph 28(1)(b)
After "British Pharmacopoeia", insert ", the European Pharmacopoeia or the United States Pharmacopeia-National Formulary".
20 Paragraph 28(1)(c)
Repeal the paragraph.
21 Subregulation 28(2)
Omit "relevant".
22 Regulation 29 (heading)
Repeal the heading, substitute:
29 Certificate of responsible analyst
23 Subregulation 29(1)
Omit "send to the sponsor of the goods a certificate signed by the analyst", substitute "issue a certificate".
24 Subregulations 29(2) and (3)
Repeal the subregulations, substitute:
(2) Within a reasonable time of the completion of the analysis, the responsible analyst must send a copy of the certificate to:
(a) the sponsor of the goods; and
(b) if the sample was taken under paragraph 25(3)(a) and the person from whom the sample was taken is not the sponsor of the goods--the person from whom the sample was taken.
25 Subregulation 29(4)
Omit "the certificate, and the copy of it referred to in subregulation (2),", substitute "a copy of the certificate sent under subregulation (2)".
26 Paragraph 29(4A)(a)
Omit "certificate or copy is sent may ask for the results of the analysis referred to in the certificate", substitute "copy is sent may ask for the results of the analysis referred to in the copy".
27 Subregulation 29(5)
Omit "of an official analyst".
28 Paragraph 29(6)(a)
Omit "of an official analyst".
29 Subregulation 29(6)
Omit "and purporting to be signed by an official analyst".
30 Subregulation 29(6)
Omit "and to have been issued under subregulation (1) or (2), as the case requires".
31 Regulation 30 (heading)
Repeal the heading, substitute:
30 Review of results of examination and analysis
32 Paragraph 30(1)(a)
Repeal the paragraph, substitute:
(a) to whom a copy of a certificate, setting out the results of the examination and analysis of goods, is sent under subregulation 29(2); and
33 Subregulation 30(2)
Omit "certificate, or the copy of the certificate, as the case may be", substitute "copy of the certificate".
34 Subregulation 30(4)
Omit "an analyst", substitute "a person (the third party )".
35 Paragraph 30(4)(a)
Omit "analyst", substitute "third party".
36 Subregulation 30(5)
Omit "relevant tests in relation to the goods", substitute "tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued".
37 Subregulation 30(6)
Omit ", at the request of the sponsor of the goods,".
38 Paragraph 30(6)(a)
Omit "the official analyst", substitute "an official analyst".
39 Subregulation 30(6)
Omit "to an analyst agreed", substitute "to a person agreed (who may be an analyst or official analyst)".
40 Subregulation 30(6)
After "and the official analyst", insert "referred to in subregulation (5)".
41 Subregulation 30(6)
Omit "an analyst nominated", substitute "a person nominated (who may be an analyst or official analyst)".
42 Subregulation 30(7)
Omit "forwarded to an analyst referred to in subregulation (6), the analyst", substitute "sent to a person as mentioned in subregulation (6), the person".
43 Paragraph 30(7)(a)
Omit "any relevant tests", substitute "the tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued".
44 Paragraphs 30(7)(b) and (c)
Omit "analyst", substitute "person".
45 Paragraph 30(7)(c)
Omit "sponsor of the goods", substitute "person who requested the review".
46 Subregulation 30(9)
Omit "official analyst", substitute "responsible analyst".
47 Subregulation 30(9)
Omit "analyst referred to in", substitute "person to whom a sample is sent as mentioned in".
48 Subregulation 30(10)
Omit "of an analyst".
49 Paragraph 30(11)(a)
Omit "an analyst", substitute "a person".
50 Paragraph 30(11)(b)
Omit "analyst", substitute "person".
51 Subregulation 30(11)
Omit ", or a copy of the certificate, and to have been issued under that subregulation", substitute "or a copy of the certificate".
Schedule 8 -- Fee waivers for certain requests relating to prescription opioids
Therapeutic Goods Regulations 1990
1 After subregulation 45(6)
Insert:
Fee waivers for prescription opioids
(7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request ) that satisfies all of the following:
(a) it is made in relation to prescription opioids that are registered goods;
(b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2020;
(c) it is made under subsection 9D(2) or (3) of the Act;
(d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).
(8) For the purposes of subregulation (7), an opioid reform request is made for an opioid reform purpose if it is made:
(a) under subsection 9D(2) of the Act, to do either or both of the following:
(i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;
(ii) reduce the class of persons for whom the goods are suitable; or
(b) under subsection 9D(3) of the Act, to introduce a smaller pack size in relation to the goods.
(9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:
(a) the opioid reform request is made under subsection 9D(3) of the Act; and
(b) paragraphs 9D(3)(b) to (c) of the Act are satisfied in relation to the request; and
(c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.
Schedule 9 -- Other amendments
Part 1 -- Fee waiver for requests to vary product information for medicine
Therapeutic Goods Regulations 1990
1 At the end of regulation 45
Add:
Fee waiver for requests to vary product information for medicine
(13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:
(a) the request is in relation to therapeutic goods that are registered; and
(b) the therapeutic goods are medicine; and
(c) paragraphs 9D(3)(b) to (c) of the Act are satisfied in relation to the request; and
(d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and
(e) the request is made in the period beginning on 1 January 2020 and ending at the end of 31 December 2020.
Therapeutic Goods Regulations 1990
2 Regulation 2
Insert:
"Practice Guideline " has the meaning given by paragraph 12AB(2)(a).
3 Regulation 2 (definition of Practice Guidelines )
Repeal the definition.
4 Paragraph 12AB(2)(a)
Omit "the Guidelines for Good Clinical Practice (the Practice Guidelines )", substitute "the Guideline for Good Clinical Practice (the Practice Guideline )".
5 Paragraph 12AB(2)(a)
Omit "published jointly by the International Conference on Harmonisation on Technical Requirements for Registration of Pharmaceuticals for Human Use and the Committee for Medicinal Products", substitute "published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use".
6 Subregulation 12AC(1)
After "clinical trial mentioned in regulation 12AB", insert "or item 3 of the table in Schedule 5A".
7 Paragraph 12AD(a)
Omit "Practice Guidelines", substitute "Practice Guideline".
8 Schedule 5A (at the end of the cell at table item 3, column 3)
Add:
; and (i) the sponsor must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial); and
(j) if a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and
(k) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised officer to do the things mentioned in regulation 12AC
Therapeutic Goods Regulations 1990
9 Schedule 5 (after table item 8A)
Insert:
| 8B | unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action) |
10 Schedule 7 (after table item 11)
Insert:
|
11A | unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action) |
Therapeutic Goods Regulations 1990
11 Regulation 2 (note 2 to the definition of Australian Approved Names List )
Omit "TGA Approved Terminology for Medicines", substitute "TGA Approved Terminology for Therapeutic Goods".
Note: This item updates the title of a document.
12 Subparagraph 16M(1)(b)(i)
Omit "subregulation 16J(3)", substitute "subregulation 16J(4)".
Note: This item fixes an incorrect cross-reference.
13 Subparagraph 16M(1)(b)(ii)
Omit "subregulation 16J(4)", substitute "subregulation 16J(3)".
Note: This item fixes an incorrect cross-reference.
Schedule 10 -- Application, saving and transitional provisions
Therapeutic Goods (Medical Devices) Regulations 2002
1 In the appropriate position in Part 11
Insert:
In this Division:
"amending regulations " means the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 .
"finally determined " : an application is finally determined at the first time both the following conditions are met:
(a) a decision has been made whether or not to grant the application;
(b) there is no longer any possibility of a change in the outcome of the decision.
"unique product identifier " , in relation to a medical device, means the unique product identifier given to the device by its manufacturer to identify the device and any variants.
Subdivision B -- Reclassification of medical devices
In this Subdivision:
"inclusion day " for an entry of a kind of transitional medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
"pre-commencement entry " : an entry of a kind of transitional medical device in the Register is a pre-commencement entry if that kind of medical device is included in the Register because of an application made before 25 August 2020 (whether the inclusion day for the entry occurred before, on or after 25 August 2020).
"transitional AIMD device " means a transitional medical device of a kind mentioned in column 1 of item 2 of the table in the definition of transitional medical device .
"transitional medical device " means a medical device of a kind mentioned in column 1 of an item in the following table if:
(a) the medical device is, immediately before 25 August 2020, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or
(b) on 25 August 2020:
(i) the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and
(ii) the application had not been finally determined.
|
Transitional medical device | ||
| Column 1 | Column 2 | |
| Item | Kind of medical device | Class of medical device or application |
| 1 | a medical device of a kind described in subclause 3.4(4B) of Schedule 2 | Class IIb |
| 2 | an active implantable medical device | Class AIMD |
| 3 | a medical device of a kind described in subclause 3.1(2A) of Schedule 2 | Class I or Class IIa |
| 4 |
a medical device of a kind described in subclause 3.1(4) of Schedule 2 | Class I, Class IIa or Class IIb |
| 5 | a medical device of a kind described in subclause 4.2(4) of Schedule 2 |
Class IIa or Class IIb |
| 6 | a medical device of a kind described in subclause 3.2(3A) of Schedule 2 | Class IIa or Class IIb |
11.40 Transitional medical devices--application of amendments
Applications and entries other than for transitional medical devices
(1) The amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations apply on and after 25 August 2020 in relation to the following:
(a) an application for a kind of medical device to be included in the Register that is made on or after 25 August 2020;
(b) a kind of medical device that is included in the Register as a result of such an application.
Applications and entries for transitional medical devices
(2) Subject to subregulations (3) and (5), the amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations apply in relation to a transitional medical device on and after 1 November 2024.
(3) The amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations do not apply in relation to a transitional medical device before the day applicable under subregulation (4) if:
(a) a person applies under the Act:
(i) on or after the inclusion day for the entry of the transitional medical device; and
(ii) on or after 25 August 2020; and
(iii) before 1 November 2024;
to have a kind (the new kind ) of medical device included in the Register; and
(b) the person gives to the Secretary a notice under regulation 11.41 in relation to the transitional medical device; and
(c) the unique product identifier of the device of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice.
(4) For the purposes of subregulation (3), the day is the day after the day on which:
(a) the person withdraws the application mentioned in paragraph (3)(a); or
(b) that application lapses under section 41FK of the Act; or
(c) that application is finally determined.
(5) If:
(a) a person is required under regulation 11.41 to give a notice to the Secretary in relation to a transitional medical device; and
(b) the person fails to give the notice in accordance with that regulation before the later of:
(i) 25 February 2021; and
(ii) the day occurring 2 months after the inclusion day for the entry of the transitional medical device;
then the amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations apply in relation to the transitional medical device on and after the later of those days.
(1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the entry of that kind of medical device is a pre-commencement entry; and
(c) a medical device of that kind is a transitional medical device.
(2) The notice must:
(a) be in writing; and
(b) state:
(i) the unique device number assigned to that kind of device under section 41FL of the Act; and
(ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
(c) be given to the Secretary before the later of:
(i) 25 February 2021; and
(ii) the day occurring 2 months after the inclusion day for the entry of the transitional medical device.
11.42 Transitional medical devices--selecting applications for auditing
Subregulation 5.3(1) does not apply to an application for inclusion of a kind of medical device in the Register as a Class III medical device if the application is for a transitional AIMD device.
11.43 Waiver of certain application fees
(1) This regulation applies in relation to an application to include in the Register a transitional AIMD device as a Class III medical device.
(2) The Secretary must waive the fee set out in paragraph (b) of column 2 in item 1.5 of the table in Part 1 of Schedule 5 in relation to the application.
(3) This regulation ceases to have effect at the end of 24 August 2021.
Subdivision C -- Programmed or programmable medical device or software that is a medical device
In this Subdivision:
"inclusion day " for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
"transitional kind of medical device " means a kind of medical device included in the Register because of an application made before 25 August 2020 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day).
Applications and entries other than a transitional kind of medical device
(1) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply on and after 25 August 2020 in relation to the following:
(a) an application for a kind of medical device to be included in the Register that is made on or after 25 August 2020;
(b) a kind of medical device that is included in the Register as a result of such an application.
Transitional kind of medical device
(2) Subject to subregulations (3) and (5), clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply in relation to a transitional kind of medical device on and after 1 November 2024.
(3) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, do not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4) if:
(a) the person applies under the Act:
(i) on or after the inclusion day for the entry of the transitional kind of medical device; and
(ii) on or after 25 August 2020; and
(iii) before 1 November 2024;
to have a kind (the new kind ) of medical device included in the Register; and
(b) the person gives to the Secretary a notice under regulation 11.46 in relation to the transitional kind of medical device; and
(c) the unique product identifier of the devices of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice.
(4) For the purposes of subregulation (3), the day is the day after the day on whichever of the following events occurs first:
(a) the person withdraws the application mentioned in paragraph (3)(a);
(b) that application lapses under section 41FK of the Act;
(c) that application is finally determined.
(5) If:
(a) a person is required under regulation 11.46 to give a notice to the Secretary in relation to a transitional kind of medical device; and
(b) the person fails to give the notice in accordance with that regulation before the later of:
(i) 25 February 2021; and
(ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device;
then clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply in relation to the transitional kind of medical device on and after the later of those days.
11.46 Secretary must be notified in relation to a transitional kind of medical device
(1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the kind of medical device so included is a transitional kind of medical device; and
(c) medical devices of that kind are programmed or programmable medical devices or software.
(2) The notice must:
(a) be in writing; and
(b) state:
(i) the unique device number assigned to that kind of device under section 41FL of the Act; and
(ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
(c) be given to the Secretary before the later of:
(i) 25 February 2021; and
(ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device.
(1) Clause 13B of Schedule 1, as inserted by Schedule 2 to the amending regulations, applies on and after 25 August 2020 in relation to the following:
(a) an application for a kind of medical device to be included in the Register that is made on or after 25 August 2020;
(b) a kind of medical device that is included in the Register as a result of such an application.
(2) Clause 13B of Schedule 1, as inserted by Schedule 2 to the amending regulations, applies in relation to a transitional kind of medical device on and after 1 November 2024.
Subdivision D -- Personalised medical devices
In this Subdivision:
"inclusion day " for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
"transitional kind of medical device " means a kind of medical device included in the Register because of an application made before 25 August 2020 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day).
11.49 Personalised medical devices--reports
(1) Subregulation 10.3A(1), as inserted by Schedule 3 to the amending regulations, applies in relation to a custom-made medical device that is manufactured on or after 25 August 2020.
(2) Subregulation 10.3A(2), as inserted by Schedule 3 to the amending regulations, applies in relation to a custom-made medical device that is imported into Australia on or after 25 August 2020.
11.50 Personalised medical devices--conformity assessment procedures
(1) The amendments of clause 7.2 of Schedule 3 made by Schedule 3 to the amending regulations apply in relation to a custom-made medical device that is manufactured on or after 25 August 2020.
(2) The repeal and substitution of subclause 7.6(2) of Schedule 3 made by Schedule 3 to the amending regulations applies in relation to a medical device that is manufactured on or after 25 August 2020.
11.51 Personalised medical devices--exemptions
(1) Item 1.5 of the table in Part 1 of Schedule 4, as in force immediately before 25 August 2020, continues to apply on and after that day in relation to the following:
(a) a custom-made medical device (within the meaning of these Regulations as in force immediately before that day) that is manufactured before that day;
(b) a custom-made medical device (within the meaning of these Regulations as in force immediately before that day) that is manufactured on or after that day, where the request from the health professional was made before that day.
(2) Items 2.12 and 2.13 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, apply in relation to a custom-made medical device that is manufactured on or after 25 August 2020, where the request from the health professional is made on or after that day.
(3) Item 2.14 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, applies in relation to a patient-matched medical device if:
(a) it is manufactured on or after 25 August 2020 and before 1 November 2024; and
(b) before 25 August 2020, information was given to the Secretary under regulation 10.3 and the patient-matched medical device is covered by the description of the kinds of medical devices referred to in paragraph 10.3(1)(b) or (2)(c).
11.52 Personalised medical devices--classification rules
Applications and entries other than a transitional kind of medical device
(1) Clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies on and after 25 August 2020 in relation to the following:
(a) an application for a kind of medical device to be included in the Register that is made on or after 25 August 2020;
(b) a kind of medical device that is included in the Register as a result of such an application.
Transitional kind of medical device
(2) Subject to subregulations (3) and (5), clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies in relation to a transitional kind of medical device on and after 1 November 2024.
(3) Clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, does not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4) if:
(a) the person applies under the Act:
(i) on or after the inclusion day for the entry of the transitional kind of medical device; and
(ii) on or after 25 August 2020; and
(iii) before 1 November 2024;
to have a kind (the new kind ) of medical device included in the Register; and
(b) the person gives to the Secretary a notice under regulation 11.53 in relation to the transitional kind of medical device; and
(c) the unique product identifier of the devices of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice.
(4) For the purposes of subregulation (3), the day is the day after the day on whichever of the following events occurs first:
(a) the person withdraws the application mentioned in paragraph (3)(a);
(b) that application lapses under section 41FK of the Act;
(c) that application is finally determined.
(5) If:
(a) a person is required under regulation 11.53 to give a notice to the Secretary in relation to a transitional kind of medical device; and
(b) the person fails to give the notice in accordance with that regulation before the later of:
(i) 25 February 2021; and
(ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device;
then clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies in relation to the transitional kind of medical device on and after the later of those days.
11.53 Secretary must be notified in relation to a transitional kind of medical device
(1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (5) if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the kind of medical device so included is a transitional kind of medical device; and
(c) medical devices of that kind are medical devices that are covered by subregulation (2), (3) or (4).
(2) This subregulation covers a medical device that is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following:
(a) the diagnosis or monitoring of a disease, injury or disability;
(b) the investigation of the anatomy or of a physiological process;
where the images are to be acquired through a method that relies on energy outside the visible spectrum.
(3) This subregulation covers a medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following:
(a) the diagnosis or monitoring of a disease, injury or disability;
(b) the investigation of the anatomy or of a physiological process.
(4) This subregulation covers a programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following:
(a) the diagnosis or monitoring of a disease, injury or disability;
(b) the investigation of the anatomy or of a physiological process.
(5) The notice must:
(a) be in writing; and
(b) state:
(i) the unique device number assigned to that kind of device under section 41FL of the Act; and
(ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
(c) be given to the Secretary before the later of:
(i) 25 February 2021; and
(ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device.
Subdivision E -- IVD companion diagnostics
11.54 IVD companion diagnostics
Applications required to be audited
(1) The amendment of paragraph 5.3(1)(j) by Schedule 4 to the amending regulations applies to applications made on or after 1 February 2020.
Classification and kind of medical device
(2) Despite the amendments made by Schedule 4 to the amending regulations on 1 February 2020, until 1 July 2022 those amendments:
(a) do not affect the classification of a device covered by subregulation (3), (4) or (5); and
(b) do not affect whether such a device is of the same kind as another device.
(3) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was either a Class 4 in-house IVD medical device or an IVD medical device other than an in-house IVD medical device, and:
(a) was included in the Register; or
(b) was the subject of an application for inclusion in the Register that had not been finally determined.
(4) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was either a Class 4 in-house IVD medical device or an IVD medical device other than an in-house IVD medical device, that:
(a) was not included in the Register but was covered by a conformity assessment certificate having effect; or
(b) was proposed to be covered by a conformity assessment certificate for which an application had been made but not finally determined.
(5) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was:
(a) a Class 1 in-house IVD medical device; or
(b) a Class 2 in-house IVD medical device; or
(c) a Class 3 in-house IVD medical device.
(6) Subregulation (2) does not prevent the making and determination on or after 1 February 2020 and before 1 July 2022 of an application for inclusion in the Register of a device covered by subregulation (3), (4) or (5) in accordance with these Regulations as amended by Schedule 4 to the amending regulations.
(7) Paragraph (h) of item 1.5 of the table in Part 1 of Schedule 5 does not apply to an application described in subregulation (6) of this regulation (made within the period described in that subregulation).
Note: This means that an application described in subregulation (6) can pass the preliminary assessment without payment of any fee.
Therapeutic Goods Regulations 1990
2 In the appropriate position in Part 9
Insert:
In this Division:
"amending regulations " means the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 .
"finally determined " : an application is finally determined at the first time both the following conditions are met:
(a) a decision has been made whether or not to grant the application;
(b) there is no longer any possibility of a change in the outcome of the decision.
Subdivision B -- Faecal microbiota transplant products
70 Faecal microbiota transplant products--Division 4 of Part 3-2A of the Act
Exemption
(1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3-2A of the Act.
(2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.
When exemption ceases
(3) Subregulation (1) ceases to have effect on 1 January 2021, subject to subregulations (4) and (5).
(4) If a sponsor of faecal microbiota transplant products applies, on or before 31 December 2020, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 January 2021.
(5) If a sponsor of faecal microbiota transplant products applies, on or before 31 December 2020, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 January 2021.
71 Faecal microbiota transplant products--Part 3-3 of the Act
(1) For the purposes of this regulation, a biological is a transitional biological if it is:
(a) a faecal microbiota transplant product; and
(b) a biological other than a Class 1 biological.
Exemption
(2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3-3 of the Act.
When exemption ceases
(3) Subregulation (2) ceases to have effect on 1 January 2021, subject to subregulation (4).
(4) If, on or before 31 December 2020, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 January 2021.
Subdivision C -- Consumer medicine information documents
72 Consumer medicine information documents
(1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.
Transitional medicines
(2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine ) that immediately before 1 January 2021 was:
(a) a registered good; or
(b) an exempt good under section 18 of the Act; or
(c) an exempt good under section 18A of the Act; or
(d) the subject of an approval or authority under section 19 of the Act; or
(e) the subject of an approval under section 19A of the Act.
(3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.
Medicines where applications not finally determined
(4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine ) while either of the following applies to the transitional application medicine:
(a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;
(b) it is included in the Register as a result of such an application.
(5) The amendments made to regulations 9A and 9B, and Schedules 12 and 13 by Schedule 6 to the amending regulations apply in relation to a supply of a transitional application medicine:
(a) if at a time before 1 January 2026 subregulation (4) ceases to apply in relation to the transitional application medicine--at that time; or
(b) in any other case--on and after 1 January 2026.
Subdivision D -- Handling and testing of samples
73 Handling and testing of samples
The repeal and substitution of subregulation 23(2) made by Schedule 7 to the amending regulations, the amendment of paragraph 25(3)(c) made by that Schedule, subregulations 25(4) and (5) as added by that Schedule and the amendments of paragraph 27(2)(a) and of regulations 28, 29 and 30 made by that Schedule apply in relation to samples taken or delivered on or after 1 January 2020.
Subdivision E -- Fee waivers and refunds for certain requests relating to prescription opioids
74 Fee waivers and refunds for certain requests relating to prescription opioids
(1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.
(2) If, on or after 31 August 2019 and before the commencement of subregulations 45(7) to (9):
(a) a person made a request (an opioid reform request ) that:
(i) was made in relation to prescription opioids that were registered goods; and
(ii) was made under subsection 9D(2) or (3) of the Act; and
(iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and
(b) the person paid the fee prescribed in Schedule 9 to these Regulations in relation to the request;
the Secretary must, on behalf of the Commonwealth, refund to the person an amount equal to the fee paid.
(3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:
(a) under subsection 9D(2) of the Act, to do either or both of the following:
(i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;
(ii) reduce the class of persons for whom the goods were suitable; or
(b) under subsection 9D(3) of the Act, to introduce a smaller pack size in relation to the goods.
(4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:
(a) the opioid reform request was made under subsection 9D(3) of the Act; and
(b) paragraphs 9D(3)(b) to (c) of the Act were satisfied in relation to the request; and
(c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.
Subdivision F -- Clinical trials
(1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.
(2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.
(3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.
(4) The amendment of Schedule 5A made by Part 2 of Schedule 9 to the amending regulations applies in relation to:
(a) requests made on or after 1 January 2020 to give information acquired before, on or after 1 January 2020; and
(b) things mentioned in regulation 12AC done on or after 1 January 2020;
in relation to a clinical trial that began before, on or after 1 January 2020.