Commonwealth Consolidated Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS REGULATIONS 1990 - REG 48

Review of decisions

Definitions

  (1)   In this regulation:

"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975 .

"eligible person" , in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.

 

Eligible persons in relation to initial decisions

Item

Column 1

Initial decision

Column 2

Eligible person

1

initial decision not covered by another item of this table

a person whose interests are affected by the initial decision

2

decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination

the person who applied for the determination

3

decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination

the priority applicant specified in the determination

4

decision under regulation   10JE or 10JF to refuse to approve an application for approval

the person who applied for the approval

5

decision under regulation   10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury

the person specified in the approval

6

decision covered by subregulation (1AB)

the sponsor concerned

"initial decision" means a decision of the Secretary under any of the following provisions:

  (ca)   subregulation   10C(3), (5) or (6);

  (e)   subparagraph   16J(1)(b)(ii);

  (ea)   paragraph   16L(3)(b);

  (eb)   paragraph   16M(1)(b);

  (ec)   subparagraph   16R(1)(b)(ii);

  (ed)   subregulation   16T(1);

  (ee)   subparagraph   16W(1)(b)(ii);

  (ef)   subregulation   16Y(1);

  (f)   subregulation   22(8);

  (fa)   paragraph   43AAH(4)(b);

  (g)   regulation   45;

  (h)   regulation   45AA.

Note:   See also subregulations (1AA) and (1AB) of this regulation.

"reviewable decision" means a decision of the Minister under subregulation   (3).

  (1AA)   Each of the following decisions of the Secretary under regulation   10JE or 10JF (about importing or exporting mercury) is an initial decision :

  (a)   a decision to refuse to approve an application for approval;

  (b)   a decision to revoke or vary an approval.

  (1AB)   Each of the following decisions of the Secretary is an initial decision :

  (a)   a decision to refuse to agree to a notification covered by paragraph   (a) of column 3 of item   3 of the table in Schedule   5A being given before the end of a period nominated by the sponsor concerned;

  (b)   a decision to refuse to agree to a notification covered by paragraph   (ha) of column 3 of item   3 of the table in Schedule   5A being given before the end of a period nominated by the sponsor concerned;

  (c)   a decision to make goods the subject of a determination as referred to in paragraph   (e) of column 3 of item   15 of the table in Schedule   5A.

Delegation

  (1A)   The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.

Requests for reconsideration of initial decisions

  (2)   An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person's notice.

  (2A)   A request under subregulation   (2) may be accompanied by information in support of the request.

Reconsideration of initial decisions

  (3)   The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation   (2), and may:

  (a)   confirm the initial decision; or

  (b)   revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.

  (3A)   In reconsidering the initial decision:

  (a)   the Minister must take into account any information referred to in subregulation   (2A); and

  (b)   the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.

  (3B)   Paragraph   (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.

  (3C)   If, under paragraph   (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:

  (a)   is taken to be a decision of the Secretary (except for the purpose of any review of the substituted decision); and

  (b)   has effect, or is taken to have had effect, on and from the date determined by the Minister.

  (4)   If a person who has made a request under subregulation   (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.

  (5)   After reconsideration of an initial decision, the inister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection   28(4) of the Administrative Appeals Tribunal Act   1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal for review of that decision.

Notices about right to seek reconsideration of initial decisions

  (6)   If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:

  (a)   seek a reconsideration of the decision under this regulation; and

  (b)   subject to the Administrative Appeals Tribunal Act 1975 , if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.

Failure to comply with subregulations (5) and (6) does not affect decisions

  (7)   Any failure to comply with the requirements of subregulation   (5) or (6) in relation to a decision does not affect the validity of the decision.

Applications for review of reviewable decisions

  (8)   An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.


AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback