THERAPEUTIC GOODS ACT 1989 - SECT 26BE Evaluation of whether to make recommendation for variation of a section 26BB determination

THERAPEUTIC GOODS ACT 1989 - SECT 26BE

Decision by Secretary whether to make recommendation

  (3)   If:

  (a)   an application is made under subsection   26BD(1) for a recommendation by the Secretary that the Minister vary a section   26BB determination; and

  (aa)   the application has passed preliminary assessment; and

  (b)   any applicable prescribed evaluation fee has been paid; and

  (c)   if further information is required to be given under subsection   (3A) within a specified period--the information is given within that period;

the Secretary must carry out an evaluation of whether to make the recommendation.

  (3A)   The Secretary may, by written notice given to a person who has made an application under subsection   26BD(1), require the person to:

  (a)   give the Secretary such further information in connection with the application as is specified in the notice; and

  (b)   do so within such reasonable period as is specified in the notice.

  (4)   After carrying out the evaluation, the Secretary must:

  (a)   make the recommendation; or

  (b)   refuse to make the recommendation.

  (5)   In deciding whether to make the recommendation, the Secretary must have regard to:

  (a)   the quality and safety of the ingredients concerned; and

  (b)   such other matters (if any) as the Secretary considers relevant.

  (5A)   If the Secretary refuses to make the recommendation, the Secretary must:

  (a)   notify the applicant in writing of his or her decision; and

  (b)   state in the notice the reasons for the decision.

Partial refund of evaluation fee in certain circumstances

  (5B)   If:

  (a)   an evaluation fee is prescribed for the purposes of paragraph   (3)(b); and

  (b)   regulations made for the purposes of paragraph   63(2)(daaa) prescribe a period within which a decision under paragraph   (4)(a) or (b) must be made; and

  (c)   the Secretary makes a decision under paragraph   (4)(a) or (b) in relation to an application under subsection   26BD(1), but not within that period;

then 25% of the evaluation fee must be refunded to the applicant.

Deemed refusal of applications in certain circumstances

  (5C)   If:

  (a)   regulations made for the purposes of paragraph   63(2)(daaa) prescribe a period within which a decision under paragraph   (4)(a) or (b) must be made; and

  (b)   at the end of that period, the Secretary has not made a decision under paragraph   (4)(a) or (b) in relation to an application under subsection   26BD(1);

the applicant may give the Secretary written notice that the applicant wishes to treat the application as having been refused.

  (5D)   A notice under subsection   (5C) may be given at any time before a decision under paragraph   (4)(a) or (b) in relation to the application is made.

  (5E)   If a notice has been given under subsection   (5C), this Act (except subsection   60(5)) has effect as if:

  (a)   the Secretary had decided not to make a recommendation under this section; and

  (b)   the Minister had made a decision under subsection   60(3) confirming the decision of the Secretary; and

  (c)   the Minister's decision had been made on the day on which notice was given to the Secretary under subsection   (5C).

Minister may vary determination

  (6)   If the Secretary makes a recommendation under paragraph   (4)(a), the Minister must:

  (a)   by legislative instrument, vary the section   26BB determination; or

  (b)   refuse to vary the section   26BB determination.

  (7)   In making a decision under subsection   (6), the Minister must have regard to:

  (a)   the recommendation made under paragraph   (4)(a); and

  (b)   such other matters (if any) as the Minister considers relevant.

Information may be given electronically

  (9)   A notice mentioned in subsection   (3A) may require or permit information 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.