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Therapeutic Goods Amendment Regulations 2010 (No. 4)

Authoritative Version
  • - F2010L02771
  • No longer in force
SLI 2010 No. 266 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to provide for the disposal of unused medical devices, allows for reduction of certain fees applying to in-vitro diagnostic medical devices and provides for other consequential changes.
Administered by: Health
Registered 28 Oct 2010
Tabling HistoryDate
Tabled HR15-Nov-2010
Tabled Senate15-Nov-2010
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2010 (No. 4)1

Select Legislative Instrument 2010 No. 266

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 27 October 2010



By Her Excellency’s Command


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2010 (No. 4).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.

4              Transitional

         (1)   This regulation applies if:

                 (a)     a person is given a notice under regulation 12AAA of the Therapeutic Goods Regulations 1990 before the day these Regulations commence (the commencement day); and

                (b)     the person has not complied with clause 1 of Schedule 5B of the Therapeutic Goods Regulations 1990 before the commencement day.

         (2)   Despite the repeal of regulation 12AAA and amendment of clause 1 by these Regulations, the person must comply with clause 1 as if it had not been amended by these Regulations.

Schedule 1        Amendments

(regulation 3)


[1]           Regulation 12AAA


[2]           Schedule 5B, clause 1


1              Early end of exemption — notice of goods held

         (1)   This clause applies if:

                (a)    the Minister makes an exemption under subsection 18A (1) of the Act in relation to specified therapeutic goods or therapeutic goods in a specified class; and

               (b)    a person is given a copy of a revocation or variation of the exemption under paragraph 18A (9B) (b) of the Act.

         (2)   The person must give the Secretary:

                (a)    notice, in writing, of the quantity and location of:

                          (i)    for a revocation — the goods over which the person has control that have not been used; or

                         (ii)    for a variation — the goods mentioned in the variation over which the person has control that have not been used; and

               (b)    a copy of any records about the goods that the person is required to keep under a condition of the exemption.

         (3)   The person must comply with subclause (2) in relation to the goods within 7 days after the day the exemption ends for the goods.

[3]           Schedule 5B, subclause 7 (2)




, in writing or by electronic communication,

[4]           Schedule 5B, after subclause 7 (3)


         (4)   In this clause:

electronic communication has the meaning given by subsection 5 (1) of the Electronic Transactions Act 1999.


1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.