Customs (Prohibited Imports) Regulations (Amendment) (Cth)

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 5aof 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 5eof 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 5aof 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 5bof 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.”.

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