Customs (Prohibited Imports) Regulations (Amendment)

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STATUTORY RULES

1970 No. 72

 

REGULATIONS UNDER THE CUSTOMS ACT 1901-1968.*

I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Customs Act 1901-1968.

Dated this second day of June, 1970.

Paul Hasluck

Governor-General.

By His Excellency’s Command,

(Sgd.) D. L. CHIPP

Minister of State for Customs and Excise.

 

Amendments of the Customs (Prohibited Imports) Regulations †

Importation of therapeutic substances.

1. Regulation 5a of the Customs (Prohibited Imports) Regulations is amended by omitting from sub-regulation (4.) the words “as the Director-General of Health thinks necessary to ensure that the substance is not used otherwise than for the purposes for which he grants the permission” and inserting in their stead the words “as are necessary to ensure that the substance is not used otherwise than for the purposes for which the Director-General of Health grants the permission”.

Licensed importers.

2. Regulation 5B of the Customs (Prohibited Imports) Regulations is amended—

(a) by omitting sub-regulation (1.) and inserting in its stead the following sub-regulation:—

“(1.) The Director-General of Health may grant a person a licence to import therapeutic substances in relation to which sub-regulation (3.) of the last preceding regulation applies.”;

(b) by omitting from sub-regulation (2.) the words “Without limiting the generality of the last preceding sub-regulation, the Director-General” and inserting in their stead the words “The Director-General”; and

 

* Notified in the Commonwealth Gazette on 2 June 1970.

† Statutory Rules 1956, No 90; as amended by Statutory Rules 1958, Nos. 6 and 67; 1956, Nos. 17, 31 and 93; 1960, No. 22; 1961, No. 117; 1962, No. 82; 1963, No. 26; 1964, Nos. 25 and 39; 1965, Nos. 81, 91, 135, 167 and 190; 1966, No. 95; 1967, Nos. 41 58, 114 and 178; 1968, Nos. 100, 141 and  161; and 1969, Nos. 2, 7, 10, 39, 43 and 218.

16453/70––Price 8c         12/25.5.1970


(c) by inserting after regulation (2.) the following sub-regulations:—

“(2a.) The Director-General of Health may refuse to grant a person a licence under sub-regulation (1.) of this regulation if—

(a) the person is not a regular importer of therapeutic substances;

(b) the person will not be in possession of information, being information that he is able and willing to furnish to the Director-General of Health, concerning the manufacture, production and handling of the therapeutic substances to be imported by him reasonably necessary to enable the Director-General of Health to ascertain the quality of those substances, the purposes for which they may be used safely and whether they are properly packed and labeled.

(c) the premises in which the therapeutic substances to be imported by the person are to be stored by the person, and the equipment to be used by the person in connexion with the storage and handling of therapeutic substances to be imported by the person, are not reasonably adequate to ensure that the quality of those substances does not deteriorate and that the substances are kept securely;

(d) the person does not maintain adequate records concerning the receipt, handling and distribution of therapeutic substances imported by him; or

(e) the Person does not have an adequate staff to handle the therapeutic substances imported by him in a manner that will ensure their safe-keeping and maintain their quality.

“(2B.) In the last preceding sub-regulation—

(a) a reference to information concerning the manufacture, production and handling of a therapeutic substance shall be read as including a reference to information concerning the procedures adopted by the manufacturer or producer of the therapeutic substance to ensure that proper standards are maintained in the manufacture or production of the substance and in the handling and packaging of the substance; and

(b) a reference to the quality of a therapeutic substance shall be read as including a reference to the composition, strength, potency, stability and sterility of the substance.

“(2C.) The Director-General of Health shall not refuse to grant a person a licence except in accordance with sub-regulations (2.) and (2a.) of this regulation.”.

Disposal of designated therapeutic substances.

3. Regulation 5e of the Customs (Prohibited Imports) Regulations is amended—

(a) by omitting paragraph (c) of sub-regulation (2.) and inserting in its stead the following paragraph;—

“(c) if the substance is to be used for experimental purposes only—

(i) the investigations into the use of the substance that are proposed to be carried out; and

(ii) the persons who propose to carry out the investigations, the qualifications of those persons and the facilities that will be available to them in the carrying out of the proposed investigations,”; and


(b) by omitting sub-regulation (3.) and inserting in its stead the following sub-regulations:—

“(3.) The Director-General of Health may, subject to the next succeeding sub-regulation, grant an application under this regulation.

“(3a.) The Director-General of Health shall not refuse to grant an application under this regulation in respect of a therapeutic substance except for reasons relating to—

(a) the quality of the therapeutic substance including the procedures adopted by the manufacturer or producer of the substance to ensure that proper standards are maintained in the manufacture or production of the substance and in the handling and packaging of the substance;

(b) the safety and efficacy of the substance for the purposes for which it is to be used;

(c) the dangers associated with the use of the substance; or

(d) if the substance is to be used for experimental purposes only—without limiting the application of the preceding paragraphs of this sub-regulation, the value to the public of the proposed experiments.

“(3b.) In this regulation, a reference to the quality of a therapeutic substance shall be read as including a reference to the composition, strength, potency, stability and sterility of the substance.”.

Director-General to give reasons for refusal.

4. Regulation 5G of the Customs (Prohibited Imports) Regulations is amended by adding at the end thereof the following sub-regulation:—

“(3.) Where the Director-General of Health is prepared to grant a person a permission under sub-regulation (1.) or (3.) of regulation 5a of these Regulations but proposes to make the permission subject to conditions to which the person objects, the Director-General of Health shall furnish to the person a statement in writing setting out his reasons for including those conditions.”.

Appeal.

5. Regulation 5g of the Customs (Prohibited Imports) Regulations is amended—

(a) by inserting after paragraph (b) of sub-regulation (1.) the following paragraph:—

“(ba) concerning the conditions to which a permission under sub-regulation (1.) or (3.) of regulation 5a of these Regulations is to be subject;”;

(b) by omitting sub-regulation (6.) and inserting in its stead the following sub-regulation:—

“(6.) Where the request to the Minister of State for Health under this regulation relates to the conditions to be included in a permission under sub-regulation (1.) or (3.) of regulation 5a of these Regulations or to the importation or disposal of a designated therapeutic substance, the Minister of State for Health shall not determine the request—

(a) until he has afforded the Australian Drug Evaluation Committee established under the Therapeutic Substances Act 1953-1959 an opportunity of considering the application to which the request relates and of furnishing advice to him relating to those conditions, or to the importation or disposal of the substance, as the case may be; or


(b) in a manner that is inconsistent with the advice furnished to him by that Committee in relation to the application.”; and

(c) by adding at the end thereof the following sub-regulation:—

“(9.) The Minister of State for Health—

(a) shall not refuse to grant a person a licence under sub-regulation (1.) of regulation 5b of these Regulations except in accordance with sub-regulations (2.) and (2a.) of that regulation; and

(b) shall not refuse to grant an application under regulation 5e of these Regulations except for reasons referred to in sub-regulation (3a.) of that regulation.”.

Printed by Authority by the Government Printer of the Commonwealth of Australia

Overview

The Statutory Rules 1970 No. 72, made under the Customs Act 1901-1968, aim to address the need for more stringent controls and oversight over the importation of therapeutic substances into Australia. Enacted by the Governor-General, acting on the advice of the Federal Executive Council, these regulations seek to ensure that therapeutic substances imported into the country meet the required standards for safety, quality, and efficacy. The policy objective is to safeguard public health by regulating the import process and setting out specific criteria for licensing and approval, thereby preventing the introduction of substandard or potentially harmful substances into the market. This legislation provides the legal framework for the Director-General of Health to grant or refuse import licenses based on the qualifications and facilities of the applicant and the quality and intended use of the therapeutic substances in question.

Scope and Application

The Statutory Rules 1970 No. 72, made under the Customs Act 1901-1968, introduce amendments to the Customs (Prohibited Imports) Regulations, focusing specifically on the importation of therapeutic substances. This legislation applies to individuals and entities seeking to import therapeutic substances into Australia, governed by the Director-General of Health. The regulations set out stringent criteria for the issuance of licences to import such substances, including requirements for the importer to be a regular importer, to possess adequate information and facilities for safe storage and handling, and to maintain appropriate records and staff. The Director-General of Health has the authority to refuse a licence based on these criteria, and must provide written reasons if conditions are imposed on a granted permission. Furthermore, the regulations detail the processes and considerations for the disposal of designated therapeutic substances, including provisions for experimental use, and mandate that the Minister of State for Health consider advice from the Australian Drug Evaluation Committee before making certain determinations. These amendments extend the application of the legislation through subordinate instruments, ensuring compliance and oversight within the specified scope of therapeutic substances importation and disposal.

Key Provisions

The Statutory Rules 1970 No. 72, made under the Customs Act 1901-1968, amend the Customs (Prohibited Imports) Regulations to update the processes and conditions for importing therapeutic substances. Regulation 5a (1) now mandates that any therapeutic substance imported requires the Director-General of Health's permission, with specific conditions ensuring the substance is used only for its intended purpose. Regulation 5B (1) allows the Director-General to grant a license to import these substances, subject to certain criteria. Notably, the Director-General can refuse a license if the applicant is not a regular importer, lacks necessary information about the substance, does not have adequate storage facilities, fails to maintain proper records, or lacks a competent staff to handle the substances (Regulation 5B (2a)). Regulation 5e (2) and (3) clarify that the Director-General can grant an application to use therapeutic substances for experimental purposes, but only if certain quality, safety, efficacy, and public value criteria are met. Regulation 5G (3) requires the Director-General to provide written reasons if he imposes conditions on a permission that the applicant objects to, while Regulation 5G (6) and (9) mandate that the Minister of State for Health consider advice from the Australian Drug Evaluation Committee before making decisions on import permissions and conditions. The Regulations impose several obligations on parties and entities. Importers must obtain permission from the Director-General of Health and comply with any conditions attached to that permission (Regulation 5a). They must also ensure that they meet all the criteria set out in Regulation 5B (2a) for obtaining a license. The Director-General of Health must provide reasons in writing if he refuses a license or imposes conditions on a permission (Regulation 5G (3)). The Minister of State for Health must consider the advice of the Australian Drug Evaluation Committee before making decisions on import permissions and conditions (Regulation 5G (6) and (9)). Breach of these Regulations can result in serious consequences. Importing therapeutic substances without the necessary permission or in violation of the conditions attached to that permission is an offence and can lead to criminal charges. The maximum penalties for such offences are not specified in the Regulations but can be severe under the Customs Act 1901-1968. Additionally, failure to comply with the obligations imposed by the Regulations can lead to civil consequences, such as fines or other penalties.

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