Therapeutic Goods Act 1989

The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will:

allow an authorised person:

to enter, at any reasonable time, any premises (including premises outside Australia) at which that person or any other person deals with the biological, complies with record‑keeping conditions under paragraph 32EC(2)(c) or keeps documents that relate to the biological; and

while on those premises, to inspect those premises and any biological on those premises and to examine, take measurements of, conduct tests on or take samples of any biological on those premises or any thing on those premises that relates to any biological; and

while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

while on those premises, to inspect, and make copies of, any records kept in compliance with a condition under paragraph 32EC(2)(c); and

while on those premises, to inspect, and make copies of, any documents that relate to the biological; and

if requested to do so by an authorised person, produce to the person such documents relating to the biological included in the Register as the person requires and allow the person to copy the documents; and

if requested to do so by an authorised person, make any record kept in compliance with a condition under paragraph 32EC(2)(c) available to the authorised person for inspection:

if the authorised person requires the record to be made available immediately—immediately; and

if the authorised person requires the record to be made available at or before a time specified by the authorised person—at or before that time; and

in the form required by the authorised person.

An authorised person is not authorised to enter premises as mentioned in subsection (1) unless the person has shown his or her identity card issued under section 52 if required by the occupier of the premises. For the purposes of this subsection, occupier, in relation to premises, includes a person present at the premises who is in apparent control of the premises.

The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will deliver a reasonable number of samples of the biological if the Secretary so requests:

within the period, of not less than 14 days after the day the request is made, specified in the request; and

in accordance with any other requirements specified in the request.

The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will:

if a manufacturer who was not nominated as a manufacturer of the biological in the application for inclusion of the biological in the Register is to become a manufacturer of a step in the manufacture of the biological—inform the Secretary in writing of that fact and of the name and address of that manufacturer before that manufacturer begins to carry out that step; and

if premises that were not nominated in the application as premises to be used in the manufacture of the biological are to become premises used in a step in the manufacture of the biological—inform the Secretary in writing of that fact and of the name and address of the new premises before the premises are first so used.

The inclusion of a biological, other than a Class 1 biological, in the Register is subject to a condition that:

each step in the manufacture of the biological that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and

each step in the manufacture of the biological that is carried out outside Australia is the subject of a certification in force under subsection 32EB(2).

Subsection (5) does not apply if the biological is exempt from the operation of Part 3‑3.

Paragraph (5)(b) does not apply in relation to a step that was the subject of any evaluation under section 32DE. This subsection ceases to apply in relation to that step if either or both of the following occur:

that step begins to be carried out at premises that are different from the premises in respect of which that evaluation was conducted;

that step begins to be carried out by a manufacturer that is different from the manufacturer in respect of which that evaluation was conducted.

Paragraph (5)(b) does not apply in relation to a step that:

is the subject of a certification in force under subsection 32DCA(5); or

was not required to be the subject of a decision under that subsection because of subsection 32DCA(7).

Paragraph (7A)(a) ceases to apply in relation to that step if either or both of the following occur:

that step begins to be carried out at premises that are different from the premises in respect of which that certification was given;

that step begins to be carried out by a manufacturer that is different from the manufacturer in respect of which that certification was given.

The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will not supply a batch of the biological in Australia, or export a batch of the biological from Australia, after the expiry date for the biological.

The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will not, by any means, advertise the biological for an indication other than an indication accepted in relation to that inclusion.