5Importation of drugs

#### 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 is imported in a form (including a concentration) specified in the approval; (c) the drug is imported by a person, or class of persons, specified in the approval; (d) the drug does not exceed a value or amount specified in the approval; (e) the drug is imported in a way, or by a means, specified in the approval. (4) An application for a licence to import drugs or for a permission to import a drug shall be in writing and shall be lodged with the Secretary. (5) Where a person makes, in accordance with subregulation (4), an application for a licence or permission referred to in that subregulation, the Secretary or an authorised person shall, subject to this regulation, grant to the person the licence or permission, as the case may be. (6) An applicant for a licence or permission referred to in subregulation (4) shall, on being so requested by the Secretary or an authorised person, furnish in writing to the Secretary such information as the Secretary or authorised person reasonably may require in relation to the application. (7) The Secretary or an authorised person shall not grant to an applicant a licence to import drugs unless: (a) the applicant has furnished all the information requested by the Secretary or authorised person under subregulation (6); (b) the applicant is a fit and proper person to be granted a licence to import drugs; (c) the persons (if any) that the applicant: (i) has appointed, or proposes to appoint, as agents; or (ii) has employed or proposes to employ; for the purposes of the business carried on by the applicant in relation to drugs, are fit and proper persons to be so appointed as agents or so employed; and (d) the premises on which the applicant proposes to keep the drugs that will come within the applicant’s possession during the currency of the licence are secure for that purpose. (8) A licence to import drugs shall, unless previously revoked, remain in force for such period as is specified in the licence. (9) A licence to import drugs is granted subject to compliance by the holder of the licence with the following conditions or requirements: (a) the holder of the licence shall: (i) keep in safe custody at all times any drug that is in the holder’s possession; and (ii) if the drug is moved from one place to another, take adequate precautions to ensure that the removal is safely carried out; (b) the holder of the licence shall take such reasonable precautions as the Secretary or an authorised officer, or the Comptroller‑General of Customs, directs for the purpose of ensuring that there is no danger of loss or theft of any drug in the possession of the holder of the licence; (c) the holder of the licence shall not dispose of any drug, being a drug, other than methaqualone, referred to in paragraph (a) of the definition of drug in subregulation (20), unless satisfied that the drug will be used solely for medical or scientific purposes; (ca) the holder of the licence shall not dispose of the drug methaqualone unless satisfied that the drug will be used solely for scientific purposes; (d) the holder of the licence shall record in a book kept for that purpose: (i) the name and quantity of each drug that is in the holder’s possession and, where any such drug has been obtained from another person, the name and address of that other person; (ii) where the holder of the licence supplies any quantity of a drug to another person—the quantity of the drug so supplied and the name and address of the other person; and (iii) where the holder of the licence uses a drug in the manufacture of another drug or an exempted preparation—the quantity of the drug used, lost, destroyed, evaporated or wasted in that manufacture and the quantity and nature of the other drug or exempted preparation manufactured; (e) the holder of the licence shall, when required by the Secretary or an authorised officer, or the Comptroller‑General of Customs, produce to that person for examination: (i) any book kept in accordance with paragraph (d); and (ii) any drug in the possession of the holder of the licence; (f) the holder of the licence shall retain any book kept in accordance with paragraph (d) until the Secretary or an authorised person approves of its destruction; (g) the holder of the licence shall, within 5 days after the expiration of a report week, furnish to the Secretary a return setting out the entries recorded in respect of the report week in the book referred to in paragraph (d); (h) the holder of the licence shall, within 14 days after receiving a notice in writing from the Secretary or an authorised person, furnish to the Secretary such information as is requested in the notice, being information with respect to: (i) the orders for drugs placed with the holder of the licence within such period immediately preceding the date of the notice as is specified in the notice; (ii) the orders for drugs that the holder of the licence reasonably expects to be placed with the holder within such period immediately following the date of the notice as is specified in the notice; or (iii) any proposal of the holder of the licence to manufacture or sell by wholesale, within such period immediately following the date of the notice as is specified in the notice, a drug that the holder has not previously manufactured or sold by wholesale; (j) the holder of the licence shall in respect of each permission to import a drug that is granted to the holder during the currency of the licence, being a permission that specifies a condition or requirement to be complied with by the holder, comply with that condition or requirement. (10) The Secretary or an authorised person shall not grant to an applicant a permission to import a drug unless: (a) the applicant has furnished all the information requested by the Secretary or authorised person under subregulation (6); (b) in the case of a drug that is included in Schedule 1 or 2 to the Single Convention: (i) where the drug is required by the applicant for the manufacture of a drug at certain premises—if the Narcotic Drugs Act 1967 applies in relation to that manufacture, the applicant is, for the purposes of that Act, the holder of a manufacturer’s licence in relation to the manufacture of the last‑mentioned drug at those premises and, if, under a law of the State or Territory in which those premises are situated, the manufacture of that drug is prohibited unless a licence to manufacture the drug has been granted under that law, the applicant is, for the purposes of that law, the holder of a licence authorising the applicant to manufacture the drug at those premises; (ii) where the drug is required by the applicant for the purposes of the applicant’s business as a seller or supplier of drugs—the applicant is, under a law of the State or Territory in which the premises at or from which the applicant conducts that business are situated, the holder of a licence authorising the applicant to sell or supply the drug at or from those premises; or (iii) where subparagraphs (i) and (ii) do not apply—the drug is required by the applicant for medical or scientific purposes; (c) in the case of a drug, other than methaqualone, that is not included in Schedule 1 or 2 to the Single Convention: (i) where the drug is required by the applicant for the manufacture of a drug at certain premises and, under a law of the State or Territory in which those premises are situated, the manufacture of the drug is prohibited unless a licence to manufacture the drug has been granted—the applicant is, for the purposes of that law, the holder of a licence authorising the applicant to manufacture the drug at those premises; (ii) where the drug is required by the applicant for the purposes of the applicant’s business as a seller or supplier of drugs and, under a law of the State or Territory in which the premises at or from which the applicant conducts that business are situated, the sale or supply of the drug is prohibited unless a licence to sell or supply the drug has been granted—the applicant is, for the purposes of that law, the holder of a licence authorising the applicant to sell or supply the drug at or from those premises; or (iii) where subparagraphs (i) and (ii) do not apply and the drug is a drug referred to in paragraph (a) of the definition of drug in subregulation (20)—the drug is required by the applicant for medical or scientific purposes; (ca) where the drug is methaqualone—the drug is required for use by the applicant or by another person solely for scientific purposes; and (d) proper arrangements have been made by the applicant for the safe transportation and safe custody of the drug after the drug has been delivered for home consumption. (11) A permission to import a drug shall be in writing and shall specify: (a) the name and address of the holder of the permission; (b) the name of the supplier of the drug and the supplier’s address in the country from which the drug is exported; (c) the name by which the drug is commonly known and the international non‑proprietary name (if any) of the drug; (d) the quantity of the drug that the holder of the permission may import; (e) where the drug 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 specified in the permission as the period during which the importation of the drug may be effected. (16) Where the Secretary or an authorised person has specified a period under subregulation (15) in relation to the importation of a drug, that period shall, for the purposes of paragraph (1)(c), be deemed to be the period specified in the permission. (17) Where the holder of a licence to import drugs fails to comply with a condition or requirement set out in subregulation (9), the Secretary or an authorised person may revoke the licence, whether or not the holder of the licence is charged with an offence against subsection 50(4) of the Act in respect of the failure to comply with the condition or requirements. (18) Where: (a) a permission to import a drug specifies a condition or requirement to be complied with by the holder of the permission; and (b) the holder of the permission fails to comply with the condition or requirement; the Secretary or an authorised person may revoke the permission, whether or not the holder of the permission is charged with an offence against subsection 50(4) of the Act in respect of the failure to comply with the condition or requirement. (18A) Where the Secretary or an authorised person makes a decision: (a) not to grant under subregulation (5) a licence to import drugs, or a permission to import a drug; or (b) to grant under subregulation (13) a permission, to import a drug, that specifies: (i) a condition or requirement to be complied with; or (ii) a time at which a condition or requirement specified in the permission is to be complied with; or (c) not to specify under subregulation (15) a period, other than the period specified in a permission, as the period during which the importation of a drug may be effected; or (d) to revoke under subregulation (17) a licence to import drugs; or (e) to revoke under subregulation (18) a permission to import a drug; the Secretary or the authorised person, as the case requires, must give to the applicant or the holder of the licence or the holder of the permission, as the case requires, notice in writing setting out the decision as soon as practicable after the making of the decision. (19) The Secretary shall, before the commencement of each year, cause to be published in the Gazette in relation to that year, a notice entitled ‘Movements of Drugs of Dependence Calendar’ in which shall be set out the periods that are, for the purposes of this regulation, report weeks in respect of that year. (20) In this regulation: > authorised officer means an officer of the Department authorised in writing by the Secretary to be an authorised officer for paragraph (9)(b) or (e). > authorised person means a person authorised in writing by the Secretary to be an authorised person for the purposes of this regulation. > Department means the Department administered by the Minister administering the Therapeutic Goods Act 1989. > derivative means: (a) in relation to a chemical or compound—any substance chemically derived from the chemical or compound and from which the chemical or compound may be regenerated, and includes a salt of the chemical or compound; and (b) in relation to an isomer, or a mixture of isomers, of a chemical or compound—any substance chemically derived from the isomer or mixture of isomers and from which the isomer or mixture of isomers may be regenerated, and includes a salt of the isomer or mixture of isomers. > drug means: (a) a chemical, compound, or other substance or thing, that is included in Schedule 4; (b) an isomer or a mixture of isomers of a chemical or compound referred to in paragraph (a); (c) a derivative of: (i) a chemical or compound referred to in paragraph (a); or (ii) an isomer or mixture of isomers referred to in paragraph (b); (d) a substance or thing, other than an exempted preparation, that contains, or consists in part of: (i) a chemical, compound, or other substance or thing, referred to in paragraph (a); (ii) an isomer or mixture of isomers referred to in paragraph (b); or (iii) a derivative referred to in paragraph (c); or (e) a chemical or compound, other than a chemical or compound that is a drug by virtue of another paragraph of this definition, that, in the manufacture by a chemical process of a chemical or compound referred to in paragraph (a), is an immediate precursor of that chemical or compound. > exempted preparation means a substance or thing that is a preparation included in Schedule III to the Single Convention. > manufacture means: (a) in relation to a drug—the carrying out of any process by which the drug may be obtained and includes: (i) the refining of the drug; (ii) the transformation of another drug into the drug; (iii) the mixing or compounding of 2 or more drugs to make the drug; (iv) the preparation of tablets, pills, capsules, ampoules or other pharmaceutical products consisting of, or containing, the drug; and (v) the packing or re‑packing of the drug; but does not include the carrying out of any process referred to in subparagraph (iii), (iv), or (v) that is carried out by, or under the responsibility of, a person in the course of business as a pharmacist for the purpose of supplying a quantity of the drug to another person; and (b) in relation to an exempted preparation—the carrying out of any process by which the exempted preparation may be obtained other than such a process carried out by, or under the responsibility of, a person in the course of business as a pharmacist for the purpose of supplying the exempted preparation to another person. > medical practitioner means a person authorised to practice as a medical practitioner under the law of a State, a Territory or another country. > report week means each period that is set out as being a report week in a notice published in accordance with subregulation (19). > Secretary means the Secretary to the Department. > Single Convention means the Single Convention on Narcotic Drugs, 1961, being the Convention of that name that was adopted and opened for signature at New York on 30 March 1961, as amended and existing on the commencement of this regulation. > year means a period of 12 months commencing on 1 January.