Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument amends the Therapeutic Goods Regulations 1990 and Therapeutic Goods (Medical Devices) Regulations 2020 to support measures recently introduced into the Therapeutic Goods Act 1989 by the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020, and makes a number of other changes including to delay the commencement of certain medical device reforms.
Administered by: Health
Exempt from sunsetting by the Legislation (Exemptions and Other Matters) Regulation 2015 s12 item 63AA
Registered 23 Jul 2020
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 23 July 2020

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Medical device definitions and system or procedure packs                      2

Part 1—Medical device definitions                                                                                                  2

Therapeutic Goods (Medical Devices) Regulations 2002                                                             2

Part 2—System or procedure packs                                                                                                 3

Therapeutic Goods (Medical Devices) Regulations 2002                                                             3

Schedule 2—Exemption of hyperbaric oxygen therapy hoods                                            5

Therapeutic Goods (Medical Devices) Regulations 2002                                                             5

Schedule 3—Period for notifying adverse events                                                                         6

Therapeutic Goods (Medical Devices) Regulations 2002                                                             6

Schedule 4—Approving supply of therapeutic goods under authorised prescriber scheme       7

Therapeutic Goods Regulations 1990                                                                                               7

Schedule 5—Scientific advice about quality of medicine                                                       14

Therapeutic Goods Regulations 1990                                                                                             14

Schedule 6—Preliminary assessment of applications for variation of permissible ingredients determination                                                                                                                      15

Therapeutic Goods Regulations 1990                                                                                             15

Schedule 7—In‑house IVD medical devices                                                                                   18

Therapeutic Goods (Medical Devices) Regulations 2002                                                           18

Schedule 8—Changed commencement for reforms in the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019                                                            21

Part 1—Main changes                                                                                                                           21

Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019       21

Therapeutic Goods (Medical Devices) Regulations 2002                                                           21

Therapeutic Goods Regulations 1990                                                                                             22

Part 2—Other changes                                                                                                                          24

Therapeutic Goods (Medical Devices) Regulations 2002                                                           24

Schedule 9—Other amendments                                                                                                           25

Therapeutic Goods Regulations 1990                                                                                             25

Schedule 10—Application and transitional provisions                                                            28

Therapeutic Goods (Medical Devices) Regulations 2002                                                           28

Therapeutic Goods Regulations 1990                                                                                             28

 


1  Name

                   This instrument is the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

24 July 2020

2.  Schedule 1

At the same time as Part 1 of Schedule 1 to the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 commences.

25 August 2020

3.  Schedules 2 to 4

The day after this instrument is registered.

24 July 2020

4.  Schedule 5

At the same time as Schedule 2 to the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 commences.

23 July 2020

5.  Schedule 6

At the same time as Schedule 4 to the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 commences.

23 July 2020

6.  Schedule 7

The day after this instrument is registered.

24 July 2020

7.  Schedule 8, Part 1

The day after this instrument is registered.

24 July 2020

8.  Schedule 8, Part 2

25 November 2021.

25 November 2021

9.  Schedules 9 and 10

The day after this instrument is registered.

24 July 2020

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Medical device definitions and system or procedure packs

Part 1Medical device definitions

Therapeutic Goods (Medical Devices) Regulations 2002

1  Dictionary

Insert:

instructions for use, in relation to a medical device, includes information provided by the manufacturer of the device to inform a user of the device of the intended purpose of the device, of the proper use of the device and of any precautions to be taken in relation to the use of the device.

Note:          These Regulations contain requirements relating to instructions for use of a medical device. For example, clauses 13.1 to 13.4 of Schedule 1 (about essential principles) deal with information that must be included in instructions for the use of a medical device.

2  Dictionary (paragraph (b) of the definition of reusable surgical instrument)

After “appropriate procedures”, insert “(such as cleaning, disinfection and sterilisation)”.

3  Dictionary

Insert:

user of a medical device means any person (including a health professional) who uses the device.

Part 2System or procedure packs

Therapeutic Goods (Medical Devices) Regulations 2002

4  Paragraphs 3.10(1)(d) and (e)

Repeal the paragraphs, substitute:

                     (d)  a system or procedure pack to which subregulation (3) applies.

5  Subregulation 3.10(1) (notes)

Repeal the notes, substitute:

Note 1:       An exempt device is a medical device of a kind that is exempted from the operation of Division 3 of Part 4‑11 of the Act by the regulations (see subsection 3(1) of the Act). Division 7.1 and Schedule 4 to these Regulations deal with exempt devices.

Note 2:       For a system or procedure pack to which paragraph (1)(d) applies and that contains an IVD medical device and a medical device that is not an IVD medical device:

(a)    the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and

(b)    the conformity assessment procedures that must be applied to the system or procedure pack are the procedures for medical devices used for a special purpose in clause 7.5 of Schedule 3.

Note 3:       For a system or procedure pack to which paragraph (1)(d) does not apply:

(a)    the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and

(b)    the conformity assessment procedures that must be applied to the system or procedure pack are the procedures that apply to the relevant classification.

6  Subregulation 3.10(1A)

Repeal the subregulation, substitute:

Exception

          (1A)  However, paragraphs (1)(a), (b) and (c) do not apply to a Class 1 in‑house IVD medical device, a Class 2 in‑house IVD medical device or a Class 3 in‑house IVD medical device.

Note:          The conformity assessment procedures that must be applied to Class 1 in‑house IVD medical devices, Class 2 in‑house IVD medical devices or Class 3 in‑house IVD medical devices are the procedures mentioned in Part 6A of Schedule 3.

7  Paragraph 3.10(3)(a)

Repeal the paragraph, substitute:

                     (a)  where each medical device included in the system or procedure pack is a medical device to which the relevant conformity assessment procedures have been applied; and

                    (aa)  if one or more medicines, biologicals or other therapeutic goods are included in the system or procedure pack—where each such medicine, biological or other therapeutic goods are entered on the Register; and

8  Subregulation 3.10(4) (note)

Omit “the package contains a medicine”, substitute “a medicine is included in the system or procedure pack”.

9  Paragraph 7.5(2)(c) of Schedule 3

Omit “or, if relevant, the contents of packaging”, substitute “or the contents of the system or procedure pack”.

10  Paragraph 7.5(2)(d) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

11  Subparagraphs 7.5(2)(e)(i) and (ii) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

12  Paragraph 7.5(2)(f) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

13  Paragraph 7.5(2)(g) of Schedule 3

Omit “package” (wherever occurring), substitute “system or procedure pack”.

14  Subparagraph 7.5(2)(h)(i) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

15  Paragraph 7.5(2)(i) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

16  Paragraph 7.5(2)(j) of Schedule 3

After “packaging”, insert “(if any)”.

17  Paragraph 7.5(2)(j) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

18  Paragraph 7.5(2)(k) of Schedule 3

Omit “package”, substitute “system or procedure pack”.

Schedule 2Exemption of hyperbaric oxygen therapy hoods

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Part 1 of Schedule 4 (after table item 1.3)

Insert:

1.3A

Medical device that is an oxygen administration hood for use in a hyperbaric chamber for hyperbaric oxygen therapy

Schedule 3Period for notifying adverse events

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Subregulation 5.7(1)

After “subsection 41MP(2)”, insert “or 41MPA(2)”.

2  At the end of subregulation 5.7(1)

Add:

            ; and (d)  in any other case—60 days after the person becomes aware of the information.

3  After regulation 10.4

Insert:

10.4AA  Civil penalty—period for notifying adverse events

                   For the purposes of paragraph 41MPA(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MPA(2) of the Act is the relevant period specified in regulation 5.7.

4  Subclause 1.4(3) of Schedule 3 (note)

Omit “section 41MP”, substitute “sections 41MP and 41MPA”.

5  Subclause 3.4(2) of Schedule 3 (note)

Omit “section 41MP”, substitute “sections 41MP and 41MPA”.

6  Subclause 4.4(3) of Schedule 3 (note)

Omit “section 41MP”, substitute “sections 41MP and 41MPA”.

7  Subclause 5.4(3) of Schedule 3 (note)

Omit “section 41MP”, substitute “sections 41MP and 41MPA”.

8  Subclause 6.5(2) of Schedule 3 (note)

Omit “section 41MP”, substitute “sections 41MP and 41MPA”.

9  Subclause 7.5(4) of Schedule 3 (note)

Omit “section 41MP”, substitute “sections 41MP and 41MPA”.

Schedule 4Approving supply of therapeutic goods under authorised prescriber scheme

  

Therapeutic Goods Regulations 1990

1  After subregulation 12B(1A)

Insert:

          (1B)  For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:

                     (a)  the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and

                     (b)  the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and

                     (c)  the medicine is in the dosage form specified in column 3 of that item; and

                     (d)  the medicine is to be administered by the route specified in column 4 of that item; and

                     (e)  the supply is for the indication specified in column 5 of that item.

 

Specified therapeutic goods

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Active ingredient

Dosage form

Route of administration

Indication

1

aciclovir

eye

ointment

ophthalmic

treatment of herpes simplex keratitis

2

allergens—multiple, various (including control solutions)

drops

intradermal

confirmation of suspected allergic reactions

3

allergens – multiple, various (including control solutions)

drops

skin prick

confirmation of suspected allergic reactions

4

amifampridine (3,4‑diaminopyridine)

tablet

oral

treatment of Lambert‑Eaton Myasthenic Syndrome

5

betaxolol 0.25% (preservative free)

eye drops

ophthalmic

treatment of elevated intraocular pressure where other treatments are inappropriate

6

bismuth subcitrate

tablet

oral

treatment of resistant Helicobacter Pylori infection

7

buspirone

tablet

oral

treatment of generalised anxiety disorders

8

calcitriol

liquid

oral

prevention of hypophosphatemic rickets in children; or

treatment of hypoparathyroidism (with severe hypocalcaemia)

9

carbidopa

tablet

oral

premedication for F‑18 DOPA imaging

10

cholecalciferol

capsule

oral

treatment of severe vitamin D deficiency and prevention of osteoporosis

11

cholecalciferol

injection

intramuscular

treatment of severe vitamin D deficiency and prevention of osteoporosis

12

cinnarizine

tablet

oral

treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).

13

clobetasol propionate 0.05%

cream

topical

treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed

14

clobetasol propionate 0.05%

lotion

topical

treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed

15

clobetasol propionate 0.05%

ointment

topical

treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed

16

clofazimine

capsule

oral

treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed mycobacterium avium paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non‑tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist

17

cyclopentolate, 0.2%, and phenylephrine, 1%

eye drops

ophthalmic

production of mydriasis

18

cyclosporin, 0.05%

eye drops, emulsion

ophthalmic

treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)

19

deflazacort

tablet

oral

treatment of Duchenne muscular dystrophy

20

dehydrated ethanol (alcohol) 96% ‑ 100%

ampoule

topical

treatment of progressive keratoconus and intra‑operative use in superficial keratectomy (single use per procedure)

21

dexamethasone (preservative free)

eye drops

ophthalmic

treatment of inflammatory conditions of the eye that are non‑infected and steroid responsive in patients sensitive to preservative‑containing formulations

22

diazoxide

tablet

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma

23

diazoxide

capsule

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma

24

diazoxide

suspension

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma

25

diflunisal

tablet

oral

treatment of amyloidosis

26

dimethyl sulfoxide (DMSO)

solution

intravesical

symptomatic relief of interstitial cystitis

27

doxycycline

injection

intralesional

sclerotherapy of lymphatic malformations

28

F‑18 DCFPyl (PSMA)

injection

intravenous

prostate cancer imaging study

29

F‑18 myocardial perfusion tracer (18F flurpiridaz)

injection

intravenous

myocardial perfusion study

30

F‑18 NaF (sodium fluoride)

injection

intravenous

bone study

31

flunarizine

tablet

oral

treatment of vestibular disorders or prophylactic treatment of migraine

32

flunarizine

capsule

oral

treatment of vestibular disorders or prophylactic treatment of migraine

33

furazolidone

tablet

oral

treatment of resistant Helicobacter Pylori infection

34

Gallium‑68
(Ga‑68) Galligas

aerosol

inhalation

lung ventilation study

35

Gallium‑68
(Ga‑68) ‑ MAA

injection

intravenous

lung perfusion study

36

Gallium‑68 prostate specific membrane antigen (PSMA)

injection

intravenous

prostate cancer imaging study

37

glycopyrronium bromide

tablet

oral

treatment of excessive salivation in patients with neurological conditions

38

hyoscine hydrobromide

patch

transdermal

treatment of excessive salivation

39

hypertonic sodium chloride, 5 %

eye ointment

ophthalmic

temporary relief of corneal oedema (hypertonicity)

40

hypertonic sodium chloride, 5%

eye drops

ophthalmic

temporary relief of corneal oedema (hypertonicity)

41

indigo carmine

injection

intravenous

intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures

42

indocyanine green dye

injection

intravenous

intra‑operative diagnostic use

43

levofloxacin

tablet

oral

treatment of resistant Helicobacter Pylori infection or drug resistant tuberculosis

44

levomepromazine

tablet

oral

treatment of nausea and vomiting or agitation

45

levomepromazine

injection

subcutaneous

treatment of nausea and vomiting or agitation

46

lorazepam

injection

parenteral

treatment of acute severe behavioural episodes in the hospital setting

47

ketotifen

tablet

oral

treatment of allergic conditions

48

melatonin

syrup

oral

treatment of sleep disorders

49

melatonin

capsule

oral

treatment of sleep disorders

50

melatonin

immediate release tablet

oral

treatment of sleep disorders

51

melatonin

lozenge

oral

treatment of sleep disorders

52

mexiletine

tablet

oral

treatment of ventricular arrhythmia or myotonic disorders

53

mexiletine

capsule

oral

treatment of ventricular arrhythmia or myotonic disorders

54

moxifloxacin 0.5%

eye drops

ophthalmic

treatment of refractory bacterial conjunctivitis

55

nadolol

tablet

oral

treatment of ventricular tachycardia or long QT Syndrome

56

natamycin 5%

eye drops

ophthalmic

treatment of refractory fungal blepharitis, conjunctivitis or keratitis

57

neomycin

tablet

oral

sepsis prevention for colorectal operation

58

nicotine in solution, salt or base form

liquid or solid

inhalation

smoking cessation

59

nitazoxanide

tablet

oral

treatment of giardiasis, cryptosporidiosis or blastocystis

60

nitazoxanide

suspension

oral

treatment of giardiasis, cryptosporidiosis or blastocystis

61

paromomycin

capsule

oral

antiprotozoal treatment of any of the following amoebic infections:

(a) blastocystis hominis;

(b) dientomoeba fragilis;

(c) entamoeba histolytica;

(d) parasite infection

62

pimozide

tablet

oral

treatment of schizophrenia, chronic psychosis or Tourette syndrome

63

pristinamycin

tablet

oral

treatment of confirmed methicillin‑resistant Staphylococcus aureus or vancomycin‑resistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or

treatment of refractory or resistant mycoplasma genitalium infections; or

treatment of other infections as prescribed by an infectious disease specialist

64

pyrazinamide

tablet

oral

treatment of tuberculosis

65

riboflavin, 0.1% in 20% dextran

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

66

riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

67

riboflavin, 0.1% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

68

riboflavin, 0.22% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

69

ripasudil 0.4%

eye drops

ophthalmic

treatment of refractory corneal oedema or refractory glaucoma

70

sodium benzoate

tablet

oral

treatment of urea cycle disorders

71

tacrolimus 0.03%

ointment

topical

treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in children

72

tacrolimus 0.1%

ointment

topical

treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in adults

73

tizanidine

capsule

oral

treatment of spasticity where other treatments have failed

74

tizanidine

tablet

oral

treatment of spasticity where other treatments have failed

75

tetracycline

capsule

oral

treatment of resistant Helicobacter Pylori infection

76

tetracycline

tablet

oral

treatment of resistant Helicobacter Pylori infection

77

tick‑borne encephalitis vaccine

injection

intramuscular

prevention of tick‑borne encephalitis

78

tinidazole

tablet

oral

treatment of trichomonas vaginalis infections of the genito‑urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or

treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or

prevention of infection of the surgical site

79

triamcinolone acetonide

suspension for injection

ophthalmic

treatment of non‑infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post‑operative macular oedema (cataract surgery)

80

verteporfin

powder for injection

intravenous infusion

photosensitisation for photodynamic therapy

81

yttrium‑90 (Y‑90) Citrate

injection

intraarticular

radiosynovectomy treatment

Schedule 5Scientific advice about quality of medicine

  

Therapeutic Goods Regulations 1990

1  After Part 2D

Insert:

Part 2EScientific advice about aspects of quality, safety or efficacy of medicine

  

10M  Scientific advice about aspects of quality, safety or efficacy of medicine

                   For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.

2  Clause 3 of Schedule 9 (after table item 1AB)

Insert:

1ABA

Fee for the purposes of paragraph 22G(8)(b) of the Act for a request under section 22G of the Act

8,570

Schedule 6Preliminary assessment of applications for variation of permissible ingredients determination

  

Therapeutic Goods Regulations 1990

1  Regulation 2 (definition of IN1 application)

Omit “subsection 26BE(1)”, substitute “subsection 26BD(1)”.

2  Regulation 2 (definition of IN2 application)

Omit “subsection 26BE(1)”, substitute “subsection 26BD(1)”.

3  Regulation 2 (definition of IN3 application)

Omit “subsection 26BE(1)”, substitute “subsection 26BD(1)”.

4  Regulation 2 (definition of IN4 application)

Omit “subsection 26BE(1)”, substitute “subsection 26BD(1)”.

5  Regulation 16GI (heading)

Repeal the heading, substitute:

16GI  Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made

6  Paragraph 16GI(1)(a)

Omit “been accepted or rejected”, substitute “passed preliminary assessment”.

7  Paragraph 16GI(1)(b)

Omit “if the application is accepted—”, substitute “if the application passes preliminary assessment—subject to subregulation (1A),”.

8  Subregulation 16GI(1) (table)

Repeal the table, substitute:

 

Notification of preliminary assessment of applications and period within which decisions on recommendations must be made

Item

Column 1

Kind of application

Column 2

Notification of preliminary assessment

Column 3

Decision on recommendation

1

IN1 application

Within 40 working days after the Secretary receives the application

The period of 70 working days beginning on the later of the following days:

(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;

(b) the day the evaluation fee is paid for the application

2

IN2 application

Within 40 working days after the Secretary receives the application

The period of 120 working days beginning on the later of the following days:

(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;

(b) the day the evaluation fee is paid for the application

3

IN3 application

Within 40 working days after the Secretary receives the application

The period of 150 working days beginning on the later of the following days:

(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;

(b) the day the evaluation fee is paid for the application

4

IN4 application

Within 40 working days after the Secretary receives the application

The period of 180 working days beginning on the later of the following days:

(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;

(b) the day the evaluation fee is paid for the application

9  After subregulation 16GI(1)

Insert:

          (1A)  If:

                     (a)  an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and

                     (b)  the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and

                     (c)  at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and

                     (d)  at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:

                              (i)  have already been made under subsection 26BD(1) of the Act in relation to that ingredient; and

                             (ii)  have already been the subject of notices given under subsection 26BD(5) of the Act; and

                            (iii)  have not been finally determined;

then a decision on whether to make a recommendation on the current application must be made within the period of:

                     (e)  if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or

                      (f)  if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or

                     (g)  if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or

                     (h)  if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.

          (1B)  For the purposes of this regulation, the start day is:

                     (a)  the day after all the related applications have been finally determined, unless paragraph (b) applies; or

                     (b)  if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.

          (1C)  For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.

10  Subregulation 16GI(2)

Omit “A failure to decide an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item”, substitute “A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation”.

11  Clause 5 of Schedule 9 (table items 28, 30, 32 and 34)

Omit “paragraph 26BE(2)(d)”, substitute “paragraph 26BD(3)(c)”.

Schedule 7In‑house IVD medical devices

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  At the end of clause 6B.1 of Schedule 3

Add:

                    ; (f)  notify the Secretary of the manufacture of certain Class 4 in‑house IVD medical devices.

2  At the end of Part 6B of Schedule 3

Add:

6B.8  Notification of certain Class 4 in‑house IVD medical devices being manufactured

             (1)  The manufacturer of a kind of Class 4 in‑house IVD medical device that the manufacturer intends to be used to detect the presence of, or exposure to, transmissible agents in blood, stool or other specimens from a person’s body in order to assess the suitability of the person to be a donor of human stool for use in the manufacture of a faecal microbiota transplant product must notify the Secretary, in accordance with subclauses (2) and (3), about that kind.

             (2)  A notification under subclause (1) must:

                     (a)  be in a form approved in writing by the Secretary; and

                     (b)  contain the information required by the form.

             (3)  A notification under subclause (1) must be given to the Secretary:

                     (a)  if the manufacturer manufactures such a kind of Class 4 in‑house IVD medical device on or after the commencement of this clause and before 1 July 2021—no later than 20 working days after 1 July 2021; and

                     (b)  if, on or after 1 July 2021, the manufacturer manufactures such a kind of Class 4 in‑house IVD medical device—no later than 20 working days after the manufacture.

             (4)  Only one notification is required under this clause in relation to each kind of Class 4 in‑house IVD medical device manufactured by a manufacturer.

3  Part 2 of Schedule 4 (table item 2.10, column headed “Conditions”, paragraph (c))

Repeal the paragraph.

4  Part 2 of Schedule 4 (table item 2.10, column headed “Conditions”, subparagraph (e)(ii))

Omit “, the product range,”.

5  Part 2 of Schedule 4 (table item 2.10, column headed “Conditions”, subparagraph (f)(ii))

Omit “, require tests to be conducted on or take samples of”, substitute “or require tests to be conducted on”.

6  Part 2 of Schedule 4 (after table item 2.10)

Insert:

2.10A

Medical device that is a Class 4 in‑house IVD medical device and that is intended by its manufacturer to be used to detect the presence of, or exposure to, transmissible agents in blood, stool or other specimens from a person’s body in order to assess the suitability of the person to be a donor of human stool for use in the manufacture of a faecal microbiota transplant product

(a) The device must comply with the essential principles.

(b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.

(c) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:

(i) whether the device complies with the essential principles;

(ii) whether the conformity assessment procedures have been applied to the device;

(iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part 5‑1 of the Act or the Therapeutic Goods Regulations 1990.

(d) The manufacturer of the device must, at all times, have available:

(i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or

(ii) information relating to changes to the device and quality management system.

(e) The manufacturer of the device must allow an authorised person to do any of the following:

(i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;

(ii) inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;

(iii) make any still or moving image or any recording of those premises or anything on those premises.

(f) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.

(g) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.

7  Dictionary

Insert:

faecal microbiota transplant product means a thing that:

                     (a)  comprises, contains or is derived from human stool; and

                     (b)  is for introduction into a person for a therapeutic use.

Schedule 8Changed commencement for reforms in the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

Part 1Main changes

Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

1  Subsection 2(1) (table item 2)

Repeal the item, substitute:

2.  Schedule 1

25 November 2021.

25 November 2021

2A.  Schedules 2 and 3

25 February 2021.

25 February 2021

Therapeutic Goods (Medical Devices) Regulations 2002

2  Regulation 11.39 (definition of pre‑commencement entry)

Omit “25 August 2020” (wherever occurring), substitute “25 November 2021”.

3  Regulation 11.39 (paragraphs (a) and (b) of the definition of transitional medical device)

Omit “25 August 2020”, substitute “25 November 2021”.

4  Subregulation 11.40(1)

Omit “25 August 2020” (wherever occurring), substitute “25 November 2021”.

5  Subparagraph 11.40(3)(a)(ii)

Omit “25 August 2020”, substitute “25 November 2021”.

6  Subparagraph 11.40(5)(b)(i)

Omit “25 February 2021”, substitute “25 May 2022”.

7  Subparagraph 11.41(2)(c)(i)

Omit “25 February 2021”, substitute “25 May 2022”.

8  Subregulation 11.43(3)

Omit “24 August 2021”, substitute “24 November 2022”.

9  Regulation 11.44 (definition of transitional kind of medical device)

Omit “25 August 2020”, substitute “25 February 2021”.

10  Subregulation 11.45(1)

Omit “25 August 2020” (wherever occurring), substitute “25 February 2021”.

11  Subparagraph 11.45(3)(a)(ii)

Omit “25 August 2020”, substitute “25 February 2021”.

12  Subparagraph 11.45(5)(b)(i)

Omit “25 February 2021”, substitute “25 August 2021”.

13  Subparagraph 11.46(2)(c)(i)

Omit “25 February 2021”, substitute “25 August 2021”.

14  Subregulation 11.47(1)

Omit “25 August 2020” (wherever occurring), substitute “25 February 2021”.

15  Regulation 11.48 (definition of transitional kind of medical device)

Omit “25 August 2020”, substitute “25 February 2021”.

16  Subregulations 11.49(1) and (2)

Omit “25 August 2020”, substitute “25 February 2021”.

17  Subregulations 11.50(1) and (2)

Omit “25 August 2020”, substitute “25 February 2021”.

18  Subregulations 11.51(1) and (2)

Omit “25 August 2020”, substitute “25 February 2021”.

19  Paragraphs 11.51(3)(a) and (b)

Omit “25 August 2020”, substitute “25 February 2021”.

20  Subregulation 11.52(1)

Omit “25 August 2020” (wherever occurring), substitute “25 February 2021”.

21  Subparagraph 11.52(3)(a)(ii)

Omit “25 August 2020”, substitute “25 February 2021”.

22  Subparagraph 11.52(5)(b)(i)

Omit “25 February 2021”, substitute “25 August 2021”.

23  Subparagraph 11.53(5)(c)(i)

Omit “25 February 2021”, substitute “25 August 2021”.

Therapeutic Goods Regulations 1990

24  Subregulation 70(3)

Omit “1 January 2021”, substitute “1 July 2021”.

25  Subregulation 70(4)

Omit “31 December 2020”, substitute “30 June 2021”.

26  Subregulation 70(4)

Omit “1 January 2021”, substitute “1 July 2021”.

27  Subregulation 70(5)

Omit “31 December 2020”, substitute “30 June 2021”.

28  Subregulation 70(5)

Omit “1 January 2021”, substitute “1 July 2021”.

29  Subregulation 71(3)

Omit “1 January 2021”, substitute “1 July 2021”.

30  Subregulation 71(4)

Omit “31 December 2020”, substitute “30 June 2021”.

31  Subregulation 71(4)

Omit “1 January 2021”, substitute “1 July 2021”.

Part 2Other changes

Therapeutic Goods (Medical Devices) Regulations 2002

32  At the end of regulation 5.11

Add:

             (5)  If:

                     (a)  on a day on or after 25 November 2021 medical devices of a kind (the current kind of medical device) referred to in a particular paragraph of subregulation (1) are included in the Register because of the amendments made by the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019; and

                     (b)  immediately before that day, those devices were of a kind (the previous kind of medical device) referred to in a different paragraph of subregulation (1) and were included in the Register;

then subparagraph (4)(a)(i) applies in relation to the current kind of medical device as if the day when the current kind of medical device is included in the Register were the day when the previous kind of medical device was included in the Register.

Schedule 9Other amendments

  

Therapeutic Goods Regulations 1990

1  Regulation 2 (paragraph (a) of the definition of designated therapeutic goods)

Repeal the paragraph.

2  Subregulation 10C(4)

Repeal the subregulation.

3  Regulation 12B (heading)

Omit “and therapeutic devices”.

4  Subregulation 12B(4)

Repeal the subregulation.

5  Paragraph 15(1)(a)

Repeal the paragraph.

6  Regulation 16

Repeal the regulation.

7  Subregulation 48(1) (paragraph (ca) of the definition of initial decision)

Omit “(4),”.

8  Part 1 of Schedule 3 (heading)

Repeal the heading, substitute:

Part 1Medicines

9  Part 1 of Schedule 3 (table item 3)

Repeal the item.

10  Schedule 4 (table items 2 and 11)

Repeal the items.

11  Schedule 5A (table item 1A, column 3, subparagraph (b)(i))

Omit “therapeutic devices and”.

12  Schedule 5A (table item 1A, column 3, subparagraph (b)(ii))

Repeal the subparagraph, substitute:

(ii) in the case of biologicals—the biologicals must be destroyed or returned to the consignor of the biologicals within 1 month of the decision not to include the biologicals

13  Schedule 5A (table item 4, column 3, subparagraph (g)(ii))

Omit “therapeutic device or”.

14  Schedule 5A (table item 8, column 3, subparagraph (f)(ii))

Omit “therapeutic device or”.

15  Schedule 5A (table item 10, column 3, subparagraph (h)(ii))

Omit “therapeutic device or”.

16  Schedule 5A (table item 11, column 3, subparagraph (g)(ii))

Omit “therapeutic device or”.

17  Schedule 5A (table item 12, column 3, subparagraph (g)(ii))

Omit “therapeutic device or”.

18  Schedule 6

Repeal the Schedule.

19  Schedule 7 (table item 2, column 2, paragraph (b))

Omit “licensed manufacturers”, substitute “a licensed manufacturer’.

20  Schedule 7 (table item 3)

Repeal the item.

21  Schedule 7 (table item 22, column 2)

Omit “radiopharmaceuticals if”, substitute “radiopharmaceuticals that are”.

22  Schedule 7 (table item 22, column 2, paragraphs (a) and (b))

Omit “the radiopharmaceuticals are”.

23  Schedule 7 (table item 23, column 2)

Omit “radiopharmaceutical active ingredients if”, substitute “radiopharmaceutical active ingredients that are”.

24  Schedule 7 (table item 23, column 2, paragraphs (a) and (b))

Omit “the ingredients are”.

25  Schedule 8 (cell at table item 1, column 3)

Repeal the cell, substitute:

the manufacture of a medicine by a medical practitioner or a dentist specifically for a patient under the medical practitioner’s or dentist’s care

26  Clause 3 of Schedule 9 (table item 2A)

After:

 

(b) a listed medicine

440

insert:

 

(ba) a disinfectant

470

27  Clause 3 of Schedule 9 (table item 3, column 2, paragraph (a))

Omit “device”, substitute “disinfectant”.

28  Clause 3 of Schedule 9 (table item 6B, column 2)

Omit “and diagnostic goods for in vitro use”.

29  Part 1 of Schedule 10 (table item 13)

Omit “, unless coated on a therapeutic device”.

30  Part 3 of Schedule 10 (table item 3)

Omit “, except a therapeutic device,”.

Schedule 10Application and transitional provisions

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  In the appropriate position in Part 11

Insert:

Division 11.11Application provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

11.55  System or procedure packs

                   The amendments made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to a system or procedure pack that is manufactured on or after the commencement of that Part.

11.56  Period for notifying adverse events

                   Paragraph 5.7(1)(d), as inserted by Schedule 3 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to information that a person becomes aware of on or after the commencement of that Schedule.

11.57  Class 4 in‑house IVD medical devices

                   Item 2.10A of the table in Part 2 of Schedule 4, as inserted by Schedule 7 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to the following:

                     (a)  a Class 4 in‑house IVD medical device that is manufactured on or after the commencement of this regulation;

                     (b)  a Class 4 in‑house IVD medical device that is manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement.

Therapeutic Goods Regulations 1990

2  In the appropriate position in Part 9

Insert:

Division 13Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

76  Approving supply of therapeutic goods under authorised prescriber scheme

                   Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.

77  Preliminary assessment of applications for variation of permissible ingredients determination

             (1)  The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.

             (2)  Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.