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Schedule 2—Other amendments

Schedule 2 Other amendments

Part 1 Amendments commencing day after Royal Assent

Therapeutic Goods Act 1989

1  After subsection 9D(2C)

Insert:

          (2D)  Subsection (2C), to the extent that it relates to therapeutic goods that are registered, applies despite subsection 16(1).

2  At the end of section 10

Add:

             (4)  Despite subsection 14(2) of the Legislation Act 2003 , an order under subsection (1) of this section, or a variation of such an order, may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

3  After subsection 19(7G)

Insert:

       (7GA)  Subsection (7F) does not apply in relation to a person and a requirement to notify a supply of therapeutic goods if a health practitioner, on behalf of the person, does the following:

                     (a)  notifies the supply to the Secretary within 28 days after the supply;

                     (b)  makes the notification in accordance with the requirements referred to in subsection (7D).

Note:          A defendant bears an evidential burden in relation to the matter in subsection (7GA): see subsection 13.3(3) of the Criminal Code .

4  At the end of subsection 25AAA(3)

Add:

                   ; (e)  empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

5  After subsection 32CM(7G)

Insert:

       (7GA)  Subsection (7F) does not apply in relation to a person and a requirement to notify a supply of a biological if a health practitioner, on behalf of the person, does the following:

                     (a)  notifies the supply to the Secretary within 28 days after the supply;

                     (b)  makes the notification in accordance with the requirements referred to in subsection (7D).

Note:          A defendant bears an evidential burden in relation to the matter in subsection (7GA): see subsection 13.3(3) of the Criminal Code .

6  At the end of subsection 32DEA(3)

Add:

                   ; (e)  empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

7  At the end of subsection 41ECA(3)

Add:

                   ; (e)  empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

8  At the end of subsection 41FKA(3)

Add:

                   ; (e)  empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

9  Subsection 41FN(1)

After “kind of device is included in the Register”, insert “will”.

10  After subsection 41HC(6F)

Insert:

        (6FA)  Subsection (6E) does not apply in relation to a person and a requirement to notify a supply of a medical device if a health practitioner, on behalf of the person, does the following:

                     (a)  notifies the supply to the Secretary within 28 days after the supply;

                     (b)  makes the notification in accordance with the requirements referred to in subsection (6C).

Note:          A defendant bears an evidential burden in relation to the matter in subsection (6FA): see subsection 13.3(3) of the Criminal Code .

11  Section 42BAA

Before “The”, insert “(1)”.

12  At the end of section 42BAA

Add:

             (2)  Despite subsection 14(2) of the Legislation Act 2003 , an instrument under subsection (1) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

13  Application and transitional provisions

(1)       The amendment of section 19 of the Therapeutic Goods Act 1989 made by this Part applies in relation to the supply of therapeutic goods on or after the commencement of this item.

(2)       The amendment of section 32CM of the Therapeutic Goods Act 1989 made by this Part applies in relation to the supply of a biological on or after the commencement of this item.

(3)       The amendment of section 41HC of the Therapeutic Goods Act 1989 made by this Part applies in relation to the supply of a medical device on or after the commencement of this item.

(4)       An instrument in force under section 42BAA of the Therapeutic Goods Act 1989 immediately before the commencement of this item continues in force on and after that commencement as if it were an instrument in force under subsection 42BAA(1) of that Act.

Part 2 Amendments commencing 28th day after Royal Assent

Therapeutic Goods Act 1989

14  Section 42DE

Repeal the section, substitute:

42DE   Applications for approval of use of restricted representation

             (1)  An application for approval of the use of a restricted representation must be made to the Secretary in accordance with a form approved, in writing, by the Secretary.

             (2)  An approval of a form may require or permit an application 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.

15  Application provision

The repeal and substitution of section 42DE of the Therapeutic Goods Act 1989 made by this Part applies in relation to applications made on or after the commencement of this item.

(143/18)