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Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010

Schedule 1 Exempting medical devices if substitutes are not widely available

   

Therapeutic Goods Act 1989

1  Section 41H

Omit “3 other”, substitute “4 other”.

2  At the end of section 41H

Add:

            ; (d)     medical devices exempted if substitutes are unavailable or in short supply.

3  At the end of Part 4-7

Add:

41HD   Approvals if substitutes for medical devices are unavailable or in short supply

             (1)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified medical device; or

                     (b)  the importation into Australia of a specified medical device and the supply in Australia of that device;

if the Secretary is satisfied that:

                     (c)  the kinds of medical devices included in the Register that could act as a substitute for the medical device are unavailable or are in short supply; and

                     (d)  either:

                              (i)  the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5); or

                             (ii)  an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device; and

                     (e)  the medical device is specified in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

Note:          For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003 .

             (2)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified medical device; or

                     (b)  the importation into Australia of a specified medical device and the supply in Australia of that device;

if the Secretary is satisfied that:

                     (c)  there are no kinds of medical devices that are included in the Register that could act as a substitute for the medical device; and

                     (d)  an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device; and

                     (e)  the medical device is specified in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

Note:          For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003 .

Application for approval

             (3)  An application for an approval must:

                     (a)  be made to the Secretary; and

                     (b)  be accompanied by such information relating to the medical device as is required by the Secretary.

Notification of Secretary’s decision

             (4)  If an application for an approval is made, the Secretary must, as soon as practicable after deciding the application, notify the applicant of:

                     (a)  the decision; and

                     (b)  if the decision is not to grant the approval—the reasons for the decision.

Determinations

             (5)  The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).

             (6)  The Secretary may, by legislative instrument, make a determination specifying medical devices that can be the subject of an approval under this section.

Conditions

             (7)  The Secretary may grant an approval subject to any conditions that are specified in the notice of approval.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

Period of approval

             (8)  The Secretary may grant an approval for such period as is specified in the notice of approval.

When approval lapses

             (9)  The approval lapses if:

                     (a)  the period specified in the notice of approval expires; or

                     (b)  a decision has been made on an application that has been made for inclusion in the Register of the kind of medical device that includes the medical device.

           (10)  The approval lapses if:

                     (a)  the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f), or paragraph (2)(c), (d), (e) or (f), as the case requires, no longer applies in relation to the medical device, or that a condition of the approval has been contravened; and

                     (b)  the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.

           (11)  The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the medical device before that lapsing. The other approval may be expressed to take effect on the expiry of that period.

Approval not a legislative instrument

           (12)  An approval under subsection (1) or (2) is not a legislative instrument.

4  After section 41JF

Insert:

41JFA   Secretary may require information relating to approvals under section 41HD

             (1)  The Secretary may give to a person who is granted an approval under subsection 41HD(1) or (2) in relation to a medical device a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of the medical device;

                     (b)  the handling of the medical device;

                     (c)  the monitoring of the supply of the medical device;

                     (d)  the results of the supply of the medical device;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to the kind of medical device that includes the medical device.

             (2)  The notice must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (3)  The notice may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

5  Paragraph 41JG(a)

Omit “or 41JF”, substitute “, 41JF or 41JFA”.

6  Section 41JG (note)

Omit “and 41JF”, substitute “, 41JF and 41JFA”.

7  Section 41JH

Omit “or 41JF”, substitute “, 41JF or 41JFA”.

8  Paragraph 41JI(1)(c)

Omit “or 41JF”, substitute “, 41JF or 41JFA”.

9  Subsection 41JJ(1)

Omit “or 41JF”, substitute “, 41JF or 41JFA”.

10  Subsection 41KA(1) (at the end of paragraph (c) of the cell at table item 3, column headed “Circumstance relating to a kind of medical device”)

Add “or”.

11  Subsection 41KA(1) (after paragraph (c) of the cell at table item 3, column headed “Circumstance relating to a kind of medical device”)

Insert:

(d) there is an approval under subsection 41HD(1) or (2) relating to devices of that kind;

12  Subsection 41KA(1) (at the end of paragraph (c) of the cell at table item 4, column headed “Circumstance relating to a kind of medical device”)

Add “or”.

13  Subsection 41KA(1) (after paragraph (c) of the cell at table item 4, column headed “Circumstance relating to a kind of medical device”)

Insert:

(d) there is an approval under subsection 41HD(1) or (2) relating to devices of that kind;

14  Subsection 41KA(1) (paragraph (d) of the cell at table item 5, column headed “Circumstance relating to a kind of medical device”)

Omit “kind.”, substitute “kind; and”.

15  Subsection 41KA(1) (at the end of the cell at table item 5, column headed “Circumstance relating to a kind of medical device”)

Add:

(e) there is not an approval under subsection 41HD(1) or (2) relating to devices of that kind.

16  Subparagraph 41MI(1)(b)(iii)

Omit “and”.

17  At the end of paragraph 41MI(1)(b)

Add:

                            (iv)  the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person; and

18  Subparagraph 41MI(2)(b)(iii)

Omit “and”.

19  At the end of paragraph 41MI(2)(b)

Add:

                            (iv)  the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person; and

20  At the end of paragraph 41MI(4)(b)

Add:

                          ; (iv)  the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person.

21  At the end of paragraph 41MIB(1)(b)

Add:

                          ; (iv)  the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person.

22  Subparagraph 41MK(b)(iii)

Omit “and”.

23  At the end of paragraph 41MK(b)

Add:

                            (iv)  the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person; and

24  At the end of subsection 41MLA(2)

Add:

                   ; (d)  representations that medical devices are the subject of an approval under subsection 41HD(1) or (2).

25  At the end of paragraph 41MN(9)(b)

Add:

                     ; or (iv)  a condition of an approval under subsection 41HD(1) or (2).

26  After subparagraph 46A(4)(a)(iia)

Insert:

                           (iib)  who has been granted an approval under subsection 41HD(1) or (2); or

27  After paragraph 56A(1)(ba)

Insert:

                   (bb)  there was no approval under subsection 41HD(1) or (2) granted to a particular person in relation to particular medical devices; or

28  After subsection 57(8)

Insert:

             (9)  The powers of the Secretary under section 41HD may be delegated only to either or both of the following persons:

                     (a)  the National Manager of the Therapeutic Goods Administration;

                     (b)  a person who holds, occupies or performs the duties of a position in the Therapeutic Goods Administration prescribed by the regulations for the purposes of this paragraph.