Scientific advice about aspects of quality, safety or efficacy of medicine
22G Scientific advice about aspects of quality, safety or efficacy of medicine
Requests about aspects of the quality of medicine
A person may request the Secretary for advice about whether, if the person were to make an application under section 23 for registration of a medicine, a prescribed aspect of the quality of the medicine, for the purposes identified by the person as purposes for which the medicine may be used, has been satisfactorily established.
Each request under subsection (1) must relate only to one aspect of the quality of the medicine.
Requests about aspects of the safety of medicine
A person may request the Secretary for advice about whether, if the person were to make an application under section 23 for registration of a medicine, a prescribed aspect of the safety of the medicine, for the purposes identified by the person as purposes for which the medicine may be used, has been satisfactorily established.
Each request under subsection (3) must relate only to one aspect of the safety of the medicine.
Requests about aspects of the efficacy of medicine
A person may request the Secretary for advice about whether, if the person were to make an application under section 23 for registration of a medicine, a prescribed aspect of the efficacy of the medicine, for the purposes identified by the person as purposes for which the medicine may be used, has been satisfactorily established.
Each request under subsection (5) must relate only to one aspect of the efficacy of the medicine.
Secretary must give advice
The Secretary must give advice in response to a request under this section that is made in accordance with this section.
How request is to be made
A request under this section:
must be made in accordance with a form approved, in writing, by the Secretary; and
must be accompanied by the fee prescribed by the regulations; and
may be accompanied by any information or documents the person making the request considers appropriate.
An approval of a form may require or permit a request, information or a document to be given in accordance with specified software requirements:
on a specified kind of data processing device; or
by way of a specified kind of electronic transmission.
This provision refers to the regulations (prescribed by the regulations
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
This Act’s bill:Second reading speech
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