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Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

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2013-2014

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

 

 

 

(1)     Page 40 (after line 12) , after Schedule 15 , insert:

Schedule 15A Public notification and recovery

   

Therapeutic Goods Act 1989

1  After paragraph 30EA(2)(b)

Insert:

                   (ba)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

                              (i)  therapeutic goods;

                             (ii)  the circumstances referred to in paragraph (1)(a) in relation to therapeutic goods;

2  At the end of subsection 30EA(2)

Add:

                   ; (d)  to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom therapeutic goods have been supplied.

3  After paragraph 32HA(2)(b)

Insert:

                   (ba)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

                              (i)  the biological;

                             (ii)  the circumstances referred to in paragraph (1)(a);

4  At the end of subsection 32HA(2)

Add:

                   ; (d)  to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom the biological has been supplied.

5  Subsection 41KA(2)

Omit “one or both”, substitute “one or more”.

6  At the end of subsection 41KA(2)

Add:

                   ; (c)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

                              (i)  medical devices of that kind;

                             (ii)  the circumstances referred to in paragraph (1)(a);

                     (d)  to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of medical devices of that kind;

                     (e)  to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom medical devices of that kind have been supplied.

7  Application of amendments

Therapeutic goods

(1)       The amendments of section 30EA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item, whether the therapeutic goods to which the requirement relates are registered or listed before or after that commencement.

Biologicals

(2)       The amendments of section 32HA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item, whether the biological to which the requirement relates is included in the Register before or after that commencement.

Medical devices

(3)       The amendments of section 41KA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item, whether the kind of medical device to which the requirement relates is included in the Register before or after that commencement.

[schedule 15A]