Therapeutic Substances Act 1937 (Cth)

 

THERAPEUTIC SUBSTANCES.

No. 22 of 1937.

An Act relating to Therapeutic Substances and for other purposes.

[Assented to 16th September, 1937.]

BE it enacted by the King’s Most Excellent Majesty, the Senate, and the House of Representatives of the Commonwealth of Australia, as follows:—

Short title.

1.This Act may be cited as the Therapeutic Substances Act 1937.

Commencement.

2.This Act shall commence on a date to be fixed by Proclamation.

Definitions.

3.In this Act, unless the contrary intention appears—

“approved overseas manufacturer” means any institution or manufacturer declared, in pursuance of this Act, to be an approved overseas manufacturer of therapeutic substances;

“therapeutic substance” means any substance declared, in pursuance of this Act, to be a therapeutic substance for the purposes of this Act.

Application of Act.

4. This Act shall not apply to vaccines prepared from microscopic organisms from the body of any person or animal for use only in the treatment of that person or animal.

Arrangement with State.

5. The Governor-General may arrange with the Governor in Council of any State for officers or authorities of the Commonwealth and officers or authorities of the State to act in aid of each other in preventing the introduction, occurrence or spread of diseases affecting man or animals.

Delegation by Minister.

6.—(1.) The Minister may, by writing under his hand, delegate any of his powers and functions under this Act in relation to any matters or class of matters, or to any particular State or Territory of the Commonwealth, so that the delegated powers and functions may be exercised by the delegate with respect to the matters or class of matters specified, or the State or Territory defined, in the instrument of delegation.

 

(2.) Every delegation by the Minister shall be revocable in writing at will, and no delegation shall prevent the exercise of any power by the Minister.

Declaration of therapeutic substances.

7.—(1.) The Minister may, by notice in the Gazette, declare any substance used in the prevention or treatment of disease in man or animals which is wholly or in part derived from microscopic organisms or from living cellular tissue to be a therapeutic substance for the purposes of this Act.

(2.) The Minister may, by notice in the Gazette, revoke or vary any declaration made in pursuance of the last preceding sub-section.

Approved overseas manufacturers.

8.—(1.) The Minister may, by notice in the Gazette, declare any institution or manufacturer of therapeutic substances in any place beyond Australia to be an approved overseas manufacturer of therapeutic substances.

(2.) The Minister may, by notice in the Gazette, revoke or vary any declaration made in pursuance of the last preceding sub-section.

Importation of therapeutic substances.

9.—(1.) Subject to this section, no person shall import any therapeutic substance unless he is licensed as prescribed to import such substances and unless the substance—

(a) has been manufactured by an approved overseas manufacturer;

(b) bears a label on which are set forth the name and address of that manufacturer and such other particulars as are prescribed; and

(c) conforms to the prescribed standard for that substance.

Penalty: One hundred pounds.

(2.) This section shall not apply to the importation of any therapeutic substance by a person engaged in scientific research who is licensed as prescribed to import therapeutic substances for the purposes of such research.

(3.) The Minister may, if he considers it expedient in the public interest so to do, or is satisfied that the substance is to be used for scientific purposes, except any specified consignment or lot of therapeutic substances from the operation of all or any of the foregoing provisions of this section.

Exportation of therapeutic substances.

10.No person shall export any therapeutic substance unless it conforms to the prescribed standard for that substance, and unless either—

(a)if imported, it has not been imported in contravention of this Act; or

(b) if manufactured in Australia, it has been manufactured by a manufacturer licensed as prescribed,

and unless it bears a label on which are set forth such particulars as are prescribed.

Penalty: One hundred pounds.

 

Examination of therapeutic substances.

11. All therapeutic substances imported or sought to be exported shall be delivered for examination and analysis to laboratories appointed by the Minister for the purpose, and shall not be entered for home consumption or shipped unless and until a person or an officer thereto authorized by the Minister certifies that all the provisions of this Act with respect to their importation or exportation, as the case may be, have been complied with.

Power to inspect premises, &c.

12.Any officer thereto authorized in writing by the Minister may—

(a)enter and inspect any premises licensed in pursuance of the regulations;

(b) inspect any equipment in such premises;

(c) examine any working processes being carried out in such premises; and

(d)take samples of any therapeutic substances or of any materials to be used in the making of therapeutic substances in such premises.

State of emergency.

13.—(1.) If at any time quarantine measures are rendered necessary by reason of the use of any therapeutic substance—

(a)causing, or threatening to cause, the occurrence in Australia of a serious outbreak of disease in man or animals; or

(b) endangering, or threatening to endanger, the life or health of man or animals,

the Governor-General may make a Proclamation to that effect, which Proclamation shall be and remain in operation for the purposes of this section until it is revoked.

(2.) The Minister may, during the operation of any such Proclamation, order any person—

(a)to destroy any specified quantity, consignment or lot of any therapeutic substance, or any materials from which that therapeutic substance can be prepared;

(b)to withdraw from sale or distribution any specified quantity, consignment or lot of any therapeutic substance, or any materials from which that therapeutic substance can be prepared; or

(c) to refrain from preparing any specified therapeutic substance.

(3.) Any person who fails to comply forthwith with the requirements of any order of the Minister given to him under this section shall be guilty of an offence.

Penalty: Five hundred pounds or imprisonment for twelve months.

(4.) An order of the Minister under this section may be given by any available means of communication.

Sale of therapeutic substances unlawfully imported.

14.Any person who sells or has in his possession for sale any therapeutic substance imported in contravention of this Act shall be guilty of an offence.

Penalty: One hundred pounds.

 

Regulations.

15.The Governor-General may make regulations, not inconsistent with this Act, prescribing all matters which by this Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed, for carrying out or giving effect to this Act, and in particular for—

(a)regulating the licensing of importers and manufacturers of therapeutic substances;

(b) prescribing the fees to be paid for licences granted under the regulations;

(c) providing for the composition, strength, quality and purity and prescribing other standards of therapeutic substances;

(d)prescribing the manner of packing of therapeutic substances which are imported or exported or carried from one State or Territory of the Commonwealth to any other Stats or Territory, and the precautions to be taken in connexion with the sale, distribution or carriage of such substances; and

(e