Therapeutic Goods Regulations 1990

For the purposes of items 18 and 19 of the table in clause 1, a sponsor may apply to the Secretary for approval of one of the following for therapeutic goods of a kind mentioned in those items:

a technical master file;

a plasma master file.

A sponsor may apply to the Secretary for approval of the following in relation to a master file that has been approved under subclause (1):

in the period starting on the day the master file is approved and ending 3 months before the approval would (but for the application under this subclause) cease to be in effect under clause 4—an annual update of the master file;

at any time after the master file is approved—a significant update of the master file.

An annual update extends the time the approval of the master file is in effect.

A significant update may be required for an approval to apply to a master file as amended (see clause 5).

An application made under subclause (1) or (2) must:

be in the form approved by the Secretary for the purposes of this paragraph; and

include the information required by the form; and

if the application is for approval of a master file or an annual update of a master file—be accompanied by the fee mentioned in item 9B of the table in clause 3 of Schedule 9 for the application.

An application is taken not to have been made if the application does not comply with the requirements referred to in subclause (3).

The Secretary may approve a form for the purposes of paragraph (3)(a).