Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16GG

Variation of certain entries in the Register--notification of effective requests and period within which decisions must be made

  (1)   For the purposes of paragraph   63(2)(df) of the Act, if the Secretary receives an RCMC1 (section   9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.

  (2)   If the Secretary receives a request of a kind mentioned in column 1 of an item in the following table:

  (a)   the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph   63(2)(de) of the Act, in column 2 of the item; and

  (b)   if the request is effective--a decision on the request must be made within the period specified, for the purposes of paragraph   63(2)(df) of the Act, in column 3 of the item.

 

Notification of effective requests and period within which decisions must be made

Item

Column 1

Kind of request

Column 2

Notification of effective requests

Column 3

Decision on request

1A

L(A)C1 (section   9D) request

Within 40 working days after the Secretary receives the request

Within 30 working days after the Secretary notifies the applicant that the request has been accepted

1B

L(A)C2 (section   9D) request

Within 40 working days after the Secretary receives the request

Within 120 working days after the Secretary notifies the applicant that the request has been accepted

1

RCMC2 (section   9D) request

Within 40 working days after the Secretary receives the request

Within 64 working days after the Secretary notifies the applicant that the request has been accepted

2

RCMC3 (section   9D) request

Within 40 working days after the Secretary receives the application

Within 120 working days after the Secretary notifies the applicant that the request has been accepted

3

RCMC4 (section   9D) request

Within 40 working days after the Secretary receives the application

Within 170 working days after the Secretary notifies the applicant that the request has been accepted

  (3)   A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.



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