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Determinations/Other as made
This instrument specifies the foreign countries in which registration or approval for general marketing of specified therapeutic goods is required for the purposes of subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989.
Administered by: Health
Registered 07 Apr 2016
Tabling HistoryDate
Tabled HR18-Apr-2016
Tabled Senate18-Apr-2016

I, ANTHONY GILL, a delegate of the Secretary of the Department of Health, make the following determination.

Dated 6th April 2016

(Signed by)


Delegate of the Secretary of the Department of Health


1            Name of determination

              This determination is the Therapeutic Goods (Foreign Countries) Determination 2016.

2            Commencement

       (1)   Each provision of this determination 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




1.  The whole of this determination

The day after this determination is registered.


Note:          This table relates only to the provisions of this determination as originally made.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

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

3            Authority

              This determination is made under subsection 19A(3) of the Therapeutic Goods Act 1989.

4            Repeal

              This determination repeals each instrument mentioned in Schedule 1.

5            Definitions

              In this determination:

              Act means Therapeutic Goods Act 1989.


Note      A number of expressions used in this determination are defined in the Act, including the following:

(a)        supply; and

(b)     therapeutic goods.

6            Foreign countries

              In relation to an application for approval under subsection 19A(1) of the Act to import into Australia, or supply in Australia, specified therapeutic goods, each of the following countries is specified for the purposes of subparagraph 19A(1)(b)(i):

(a)        Canada;

(b)        France;

(c)        Germany;

(d)        New Zealand;

(e)        Sweden;

(f)         Switzerland;

(g)        The Netherlands;

(h)        United Kingdom; and

(i)          United States of America.


Schedule 1        Repeal

(section 4)


Repeal of instruments


Instrument name and date of making

Register ID


Therapeutic Goods Act 1989 – Determination under Subsection 19A(3) (made on 5 May 2004)



Therapeutic Goods Act 1989 – Subsection 19A(3) Determination (made on 26 August 1997)




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