Document ID: chunk:federal_register_of_legislation:F2025C00211:reg:5:p1
Version: federal_register_of_legislation:F2025C00211
Segment Type: reg
Provision Reference: reg 5 (pt 1/9)
Character Range: 91989–94634

5  Importation of drugs
 (1) Subject to subregulations (2) and (2A), the importation into Australia of a drug is prohibited unless:
 (a) the person importing the drug is the holder of:
 (i) a licence to import drugs granted by the Secretary or an authorised person under this regulation; and
 (ii) a permission to import the drug granted by the Secretary or an authorised person under this regulation;
 (b) the permission referred to in subparagraph (a)(ii), or a copy of the permission, is produced to the Collector;
 (c) the drug is imported within the period specified in the permission referred to in subparagraph (a)(ii); and
 (d) the quantity of the drug that is imported does not exceed:
 (i) except where subparagraph (ii) applies—the quantity specified in the permission referred to in paragraph (a)(ii) in relation to the drug; or
 (ii) where the Collector has given a certificate or certificates under subregulation (14)—the difference between the quantity specified in the permission in relation to the drug and the quantity specified in the certificate, or, if more than one certificate has been given, the total of the quantities specified in those certificates, in relation to the drug.
 (2) Subregulation (1) does not apply to or in relation to:
 (a) a drug in respect of the importation of which an approval is in force under subregulation (3); or
 (b) a drug that is imported into Australia by a person who is a passenger on board a ship or aircraft if the drug:
 (i) is required for the medical treatment of the person or of another passenger under the care of the person;
 (ii) was prescribed by a medical practitioner for the purposes of that treatment; and
 (iii) was supplied to the person in accordance with the prescription of the medical practitioner referred to in subparagraph (ii); or
 (c) an importation that meets the requirements in paragraphs 5F(1)(a), (b) and (c).
 (2A) Subregulation (1) does not apply to a drug that is imported into Australia by a person who is a passenger on board a ship or aircraft if the drug:
 (a) is required for the medical treatment of an animal that is being imported and is under the care of the person; and
 (b) was prescribed by a veterinarian for use in the animal for the purposes of that treatment; and
 (c) was supplied to the person in accordance with the prescription of the veterinarian.
 (3) The Minister may, on the recommendation of the Secretary, by legislative instrument, approve the importation into Australia of a drug that meets one or more of the following:
 (a) the drug is specified in, or included in a class of drugs specified in, the approval;
 (b) the drug