Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 21 June 2018

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

Part 1—Medical devices

Therapeutic Goods (Medical Devices) Regulations 2002

Part 2—Variation of entries in Register

Therapeutic Goods Regulations 1990

Part 3—Evaluation of prescription and other medicines

Therapeutic Goods Regulations 1990

Part 4—Homoeopathic preparations

Therapeutic Goods Regulations 1990

Part 5—Biologicals

Therapeutic Goods Regulations 1990

Part 6—Menstrual cups and tampons

Therapeutic Goods Regulations 1990

Part 7—Variation fees for OTC medicines

Therapeutic Goods Regulations 1990

1  Name

  This instrument is the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018.

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.

Note: This table relates only to the provisions of this instrument as originally made.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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1—Amendments

Part 1—Medical devices

Therapeutic Goods (Medical Devices) Regulations 2002

1  After Division 4.1B

Insert:

Division 4.1C—Conditions

4.3G  Conditions applying automatically—information about poisons

 (1) This regulation applies to a conformity assessment certificate that covers a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.

 (2) However, this regulation does not apply to the certificate if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device.

 (3) For the purposes of subsection 41EJ(5A) of the Act, the certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will not supply a medical device of that kind if the supply would contravene Part 2 of the current Poisons Standard.

2  At the end of Division 5.2

Add:

5.13  Conditions applying automatically—information about poisons (Act s 41FN)

 (1) This regulation applies in relation to a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.

 (2) However, this regulation does not apply in relation to that kind of medical device if, under Appendix A to the current Poisons Standard, the Standard does apply to poisons in that kind of medical device.

 (3) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must not supply the device in Australia if the supply would contravene Part 2 of the current Poisons Standard.

3  In the appropriate position in Part 11

Add:

Division 11.8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

11.35  Application—regulation 4.3G (conditions applying automatically to conformity assessment certificates)

  Regulation 4.3G applies to a conformity assessment certificate issued before, on or after 1 July 2018.

11.36  Application—regulation 5.13 (conditions applying automatically to medical devices included in the Register)

  Regulation 5.13 applies to a kind of medical device included in the Register before, on or after 1 July 2018.

Part 2—Variation of entries in Register

Therapeutic Goods Regulations 1990

4  Regulation 2 (definition of TGA notifications process guidance document)

Repeal the definition (including the note), substitute:

TGA notifications process guidance document means Version 3.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 1 July 2018).

Note: The TGA notifications process guidance document could in 2018 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).

5  Subregulation 10AAB(2) (table item 6)

Repeal the item.

Part 3—Evaluation of prescription and other medicines

Therapeutic Goods Regulations 1990

6  Subregulation 16DA(1)

Omit “16C(3)(b) and 16D(3)(b)”, substitute “16C(3)(a) and (b) and 16D(3)(a) and (b)”.

7  Paragraph 16DA(1)(b)

Repeal the paragraph.

8  Before paragraph 16DA(2)(a)

Insert:

 (aa) the approval for the acceptable foreign approved medicine:

 (i) is in force; and

 (ii) was given not more than 12 months before the date of the application in relation to the evaluation;

Part 4—Homoeopathic preparations

Therapeutic Goods Regulations 1990

9  Schedule 4 (items 4A and 5)

Omit “homeopathic”, substitute “homoeopathic”.

10  Schedule 14 (item 6)

Omit “homeopathic”, substitute “homoeopathic”.

Part 5—Biologicals

Therapeutic Goods Regulations 1990

11  Regulation 2 (definition of Class 2 biological)

Repeal the definition, substitute:

Class 2 biological means a biological:

 (a) that:

 (i) has been subjected to only minimal manipulation; and

 (ii) is only for homologous use; and

 (iii) is not mentioned in Schedule 16 as a Class 1, 3 or 4 biological; or

 (b) that is mentioned in Schedule 16 as a Class 2 biological.

12  Regulation 2 (definition of Class 3 biological)

Repeal the definition, substitute:

Class 3 biological means a biological:

 (a) that is not a Class 1, 2 or 4 biological; or

 (b) that is mentioned in Schedule 16 as a Class 3 biological.

13  Regulation 2 (definition of Class 4 biological)

Repeal the definition, substitute:

Class 4 biological means a biological that is mentioned in Schedule 16 as a Class 4 biological.

14  Regulation 2 (definition of homologous use)

Repeal the definition, substitute:

homologous use: see regulation 3B.

15  Regulation 2 (definition of minimal manipulation)

Repeal the definition, substitute:

minimal manipulation: see regulation 3B.

16  Regulation 2

Insert:

original cells or tissues: see regulation 3B.

17  At the end of Part 1

Add:

3B  Definitions relating to goods comprising etc. human cells and tissues

 (1) This regulation applies to goods that comprise, contain, or are derived from human cells or tissues.

 (2) The human cells or tissues are the original cells or tissues.

 (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.

 (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.

18  Regulation 16AB

After “of the Act”, insert “and item 14 of the table in Schedule 5A to these Regulations”.

19  Paragraphs 16AB(b) and (c)

Omit “biological”, substitute “relevant biological or other goods”.

20  In the appropriate position in Part 9

Add:

Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

64  Definitions

  In this Division:

Amendment Regulations means the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018.

finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.

transitional goods means goods:

 (a) to which paragraph 4(q) of the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 applied on 30 June 2018; and

 (b) of a kind supplied in Australia on or before 30 June 2018; and

 (c) to which column 2 of item 14 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.

65  Transitional provisions—exemptions from Parts 3‑2 and 3‑2A of the Act

Exemptions

 (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:

 (a) Part 3‑2 (except sections 30EA, 31A and 31C to 31F);

 (b) Division 4 of Part 3‑2A.

 (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods 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 exemptions cease

 (3) Subregulation (1) ceases to have effect on 1 July 2019, subject to subregulations (4) and (5).

 (4) If:

 (i) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and

 (ii) the application passes preliminary assessment on or before 30 June 2019;

subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.

 (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.

Advertising offence and civil penalty

 (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.

66  Transitional provisions—exemptions from Part 3‑3 of the Act

 (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.

 (2) Subregulation (1) ceases to have effect on 1 July 2019, subject to subregulation (3).

 (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods 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 July 2019.

21  Schedule 5A (at the end of the table)

Add:

22  Schedule 7 (at the end of the table)

Add:

23  Schedule 16

Repeal the Schedule, substitute:

Schedule 16—Classes of biologicals

Note: See regulation 2.

1  Class 4 biologicals

  For the purposes of the definition of Class 4 biological in regulation 2, the following biologicals are Class 4 biologicals:

 (a) biologicals that comprise or contain:

 (i) live animal cells; or

 (ii) live animal tissues; or

 (iii) live animal organs;

 (b) biologicals to which both of the following paragraphs apply:

 (i) the biologicals comprise, contain or are derived from human cells or human tissues that have been modified to artificially introduce a function or functions of the cells or tissues;

 (ii) the artificially introduced function or functions were not intrinsic to the cells or tissues when they were collected from the donor;

 (c) pluripotent stem cells;

 (d) biologicals derived from pluripotent stem cells.

Part 6—Menstrual cups and tampons

Therapeutic Goods Regulations 1990

24  Schedule 5 (at the end of the table)

Add:

25  Schedule 5A (at the end of the table)

Add:

26  Schedule 8 (at the end of the table)

Add:

Part 7—Variation fees for OTC medicines

Therapeutic Goods Regulations 1990

27  Clause 3 of Schedule 9 (table item 2CB)

Repeal the item, substitute:

28  Clause 3 of Schedule 9 (table item 2CD)

Repeal the item, substitute:

29  Clause 4 of Schedule 9 (table items 5 and 6)

Repeal the items, substitute: