Therapeutic Goods Regulations 1990

An approval of a master file under clause 3 comes into effect on the day the approval is granted and remains in effect until the latest of the following:

15 months after the day the approval of the master file is granted;

if the Secretary approves an annual update of the master file—15 months after the day the approval of the annual update of the master file is granted;

if the sponsor makes a request under subclause (2) for an extension of the period for which the approval is in effect, either:

if the Secretary agrees to the request—the day specified under paragraph (2)(b); or

if the Secretary refuses to agree to the request—the day the sponsor is notified of the refusal.

A sponsor may request the Secretary to extend the period an approval is in effect. Such a request must:

be in writing; and

specify the day on which the period, as extended, is to end (subject to subclause (1)); and

be made at least 28 days before the day the approval would otherwise cease to be in effect under paragraph (1)(a) or (b).

On receiving a request under subclause (2), the Secretary must within 28 days either:

agree to the request; or

refuse to agree to the request.

In making a decision under subclause (3), the Secretary may, without limitation, have regard to:

whether the sponsor has made the request because of delays in receiving data from a third party; and

any effect the decision would have on the safety or quality of the therapeutic goods covered by the approval.

The Secretary must, in writing, notify a sponsor of a decision under subclause (3) as soon as practicable after the decision is made.