Document ID: chunk:federal_register_of_legislation:F2025C00211:reg:5:p6
Version: federal_register_of_legislation:F2025C00211
Segment Type: reg
Provision Reference: reg 5 (pt 6/9)
Character Range: 103853–106494

is a pharmaceutical product:
 (i) the form in which the drug is to be imported; and
 (ii) in the case of a drug referred to in paragraph (d) of the definition of drug in subregulation (20)—the strength of the active ingredient, or each active ingredient, as the case may be, that is contained in, or is part of, the drug; and
 (f) the period during which the importation may be effected under the permission.
 (12) A permission to import a drug shall not, where the drug is included in Schedule I or II of the Single Convention, specify, as the quantity of the drug that may be imported during the period specified in the permission, a quantity that, together with:
 (a) the total quantity (if any) of the drug the importation of which during the year within which the specified period occurs (in this subregulation referred to as the relevant year) has already been authorised by the Secretary or an authorised person; and
 (b) the total quantity of the drug in respect of which, having regard to the information furnished to the Secretary under subregulation (6) or paragraph (9)(h) by other persons holding a licence to import drugs, those persons may reasonably be expected to apply for permission authorising the importation of the drug during the relevant year;
exceeds the amount that, in accordance with the requirements of the Single Convention, has been determined to be the maximum amount of that drug that may be imported into Australia during the relevant year.
 (13) A permission to import a drug may specify conditions or requirements, including conditions or requirements with respect to the possession, safe custody, transportation, use or disposal of the drug, to be complied with by the holder of the permission and may, in respect of any such condition or requirement, specify the time, being a time before or after the importation of the drug, at which the condition or requirement is to be complied with by the holder of the permission.
 (15) Where:
 (a) for reasons outside the control of the holder of a permission to import a drug, the quantity, or any part of the quantity, of the drug specified in the permission could not be imported, or cannot reasonably be expected to be imported, within the period specified in the permission; and
 (b) the holder of the permission (whether before or after the expiration of the period specified in the permission) applies in writing to the Secretary for a variation of the period during which the importation of the drug may be effected;
the Secretary or an authorised person may, by writing endorsed on, or attached to, the permission, specify a period other than the period