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

Schedule 1A Product information for medicine

   

Therapeutic Goods Act 1989

1  Subsection 3(1)

Insert:

product information , in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.

2  Subsection 3(1)

Insert:

restricted medicine means:

                     (a)  a medicine specified in an instrument under subsection (2A); or

                     (b)  a medicine included in a class of medicine specified in an instrument under subsection (2B).

3  After subsection 3(2)

Insert:

          (2A)  The Minister may, by legislative instrument, specify medicines for the purposes of paragraph (a) of the definition of restricted medicine in subsection (1).

          (2B)  The Minister may, by legislative instrument, specify classes of medicine for the purposes of paragraph (b) of the definition of restricted medicine in subsection (1).

4  After section 7C

Insert:

7D   Form for product information for medicine

             (1)  The Secretary may, by writing, approve a form for product information in relation to medicine.

             (2)  The Secretary may approve different forms for different medicines or different classes of medicine.

5  Subsection 9D(5)

Repeal the subsection (not including the note).

6  After paragraph 23(2)(b)

Insert:

                   (ba)  if the application is for the registration of restricted medicine—the application is accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and

7  After paragraph 25(1)(d)

Insert:

                   (da)  if:

                              (i)  the applicant is applying for the registration of restricted medicine; or

                             (ii)  the applicant is applying for the registration of medicine (other than restricted medicine) and the applicant has been given a notice in writing by the Secretary requiring the applicant to give to the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine;

                            the product information given by the applicant in relation to the medicine; and

8  After subparagraph 25(4)(d)(i)

Insert:

                            (ia)  if the goods are restricted medicine or the goods are medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph (1)(da)(ii)—notify the applicant in writing of the product information that is approved in relation to the medicine; and

9  After section 25

Insert:

25AA   Approved product information for medicine

             (1)  If:

                     (a)  the Secretary includes restricted medicine in the Register in relation to a person under subparagraph 25(4)(d)(ii); or

                     (b)  an applicant for the registration of medicine (other than restricted medicine) is given a notice of the kind referred to in subparagraph 25(1)(da)(ii) and the Secretary includes the medicine in the Register in relation to the applicant under subparagraph 25(4)(d)(ii);

the product information that is approved under this section in relation to the medicine is the product information referred to in subparagraph 25(4)(d)(ia).

Note:          Subsection (4) deals with variation of the product information.

Transitional

             (2)  If:

                     (a)  at the start of the day the first instrument made under subsection 3(2A) or (2B) takes effect, there is medicine included in the Register in relation to a person; and

                     (b)  before that day, the Secretary, in a notice given under subsection 25(4) to the person in relation to the registration of the medicine, specified the product information that was approved by the Secretary in relation to the medicine;

then that product information (including as varied before that day) is, on and after that day, the product information that is approved under this section in relation to the medicine.

Note:          Subsection (4) deals with variation of the product information.

             (3)  If:

                     (a)  before the day the first instrument made under subsection 3(2A) or (2B) takes effect, a person made an application to include medicine in the Register; and

                     (b)  before that day and in relation to that application, the Secretary, in a notice given under subsection 25(4) to the person, specified the product information that was approved by the Secretary in relation to the medicine; and

                     (c)  on or after that day and in relation to that application, the Secretary includes the medicine in the Register in relation to the person under subparagraph 25(4)(d)(ii);

then that product information (including as varied before that inclusion) is, on and after the day the registration of the medicine commences, the product information that is approved under this section in relation to the medicine.

Note:          Subsection (4) deals with variation of the product information.

Variations

             (4)  If:

                     (a)  there is medicine included in the Register in relation to a person and there is product information approved under this section in relation to the medicine; and

                     (b)  either:

                              (i)  under section 9D, the Secretary varies the entry in the Register in relation to the medicine; or

                             (ii)  there is a change in the conditions to which the inclusion of the medicine is subject; and

                     (c)  as a result of that variation or change, the Secretary is satisfied that a variation to that product information is required;

the Secretary may, by notice in writing given to the person, make any variations that the Secretary considers appropriate to the product information that is approved in relation to the medicine.

             (5)  To avoid doubt, if product information that is approved in relation to medicine is varied under this section, that product information, as varied, becomes the product information that is approved under this section in relation to the medicine.

10  Application

(1)       Paragraph 23(2)(ba) and subparagraph 25(1)(da)(i) of the Therapeutic Goods Act 1989 , as inserted by this Act, apply in relation to applications for registration of medicine that are made after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.

(2)       Subparagraph 25(1)(da)(ii) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies in relation to applications for registration of medicine that are made on or after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.

(3)       Subparagraph 25(4)(d)(ia) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies on and after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect (whether the application for registration was made before, on or after that day).

(4)       Subsection 25AA(1) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies in relation to medicine included in the Register on or after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect (where the notification (in relation to the medicine) referred to in subparagraph 25(4)(d)(ia) of that Act also occurred on or after that day).

Note:       Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.