Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) Subject to subregulations (2), (2A) and (3), the importation into Australia of a therapeutic substance that is an antibiotic substance is prohibited unless a permission in writing to import the substance has been granted by the Secretary or an authorised person.
(2) Subregulation (1) does not apply to a substance:
(a) that is for the personal use of a passenger, or a relative of a passenger, on a ship or an aircraft; and
(b) that is brought to Australia on that ship or aircraft; and
(c) the amount of which does not exceed 3 months' supply for a person at the maximum dosage recommended by the manufacturer of the substance.
(2A) Subregulation (1) does not apply to a substance if:
(a) the substance is required for the use of an animal that is being imported and is under the care of a passenger on the same ship or aircraft; and
(b) the amount of the substance does not exceed 3 months supply of the substance at the maximum dosage recommended by the manufacturer of the substance.
(3) Subregulation (1) does not apply to a substance:
(a) imported by a member of a group of persons visiting Australia to participate in a national or international sporting event; and
(b) for use in the treatment of:
(i) a member or members of that group; or
(ii) an animal that is being imported and is under the care of the group.
(4) A permission under subregulation (1) in respect of a therapeutic substance shall be subject to such conditions imposing requirements or prohibitions on the person to whom the permission is granted with respect to:
(a) the custody, use, disposal or distribution of the therapeutic substance; or
(b) the keeping of records relating to the therapeutic substance;
as are necessary to ensure that the substance is not used otherwise than for the purposes for which the Secretary or authorised person grants the permission.
(5) Where a permission referred to in subregulation (4) is subject to a condition imposing requirements with respect to the keeping of records relating to a therapeutic substance, the permission shall be deemed to be granted subject to compliance by the person to whom it is granted with the following requirements with respect to any quantity of the therapeutic substance imported by him into Australia in accordance with the permission:
(a) the person shall, when required to do so by an authorised officer at any reasonable time of the day, produce the records kept by him in relation to the substance for examination by the authorised officer, and permit that officer to take extracts from or copies of the records; and
(b) the person shall produce to an authorised officer, at any reasonable time of the day, the quantity of the therapeutic substance, or of a substance or mixture in the preparation of which any of the therapeutic substance has been used, that is in his possession, and permit the officer to examine the substance, to weigh or otherwise ascertain the quantity of the substance and to take a sample of the substance for further examination and analysis.
(6) Where:
(a) a permission granted under subregulation (1) is subject to a condition to be complied with by a person; and
(b) the person fails to comply with the condition;
then the Secretary may revoke the permission whether or not the person is charged with an offence under subsection 50 (4) of the Act in respect of the failure to comply with the condition or requirement.
(8) In this regulation:
"authorised officer" means an officer authorised in writing by the Secretary to be an authorised officer for the purposes of subregulation (5).
"Authorised person" means a person authorised in writing by the Secretary to be an authorised person for the purposes of this regulation.
"relative" , in relation to a person, means:
(a) a spouse, child, parent or grandparent of the person; and
(b) a person living with the person as his or her spouse on a permanent domestic basis although not legally married to him or her.
"Secretary" means the Secretary to the Department administered by the Minister administering the Therapeutic Goods Act 1989 .
Note The
latest Administrative Arrangements Orders mentions
which Minister administers
the Therapeutic Goods Act 1989 .
A copy of the Orders can be found on the
internet at http://scaleplus.law.gov.au/home/docs/legtables/aao.htm .