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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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