Therapeutic Substances Act 1937

Legislation au C1937A00022 Not in force Act

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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

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;

(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

(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) prescribing penalties not exceeding One hundred pounds for offences against the regulations.

Overview

The Therapeutic Substances Act 1937 was enacted to regulate the importation, exportation, and sale of therapeutic substances, ensuring public health and safety. This Act was introduced to address the need for stringent controls over therapeutic substances, particularly those derived from microscopic organisms or living cellular tissue, to prevent the spread of diseases and ensure the quality and safety of such substances. The Act was enacted by the Parliament of Australia and includes provisions for the declaration of therapeutic substances and approved overseas manufacturers, licensing requirements for importers and manufacturers, and penalties for non-compliance. The Act also empowers the Minister to make orders during states of emergency to manage the use of therapeutic substances that pose a serious threat to public health. The Act provides for the cooperation between the Commonwealth and the States to prevent the introduction, occurrence, or spread of diseases, and it allows the Governor-General to declare a state of emergency if necessary. The Minister has the authority to delegate powers and functions, subject to revocation, and to make regulations necessary for the effective implementation of the Act. This includes regulations on the licensing of importers and manufacturers, the standards for therapeutic substances, and penalties for offences against the regulations. The Act ensures that all therapeutic substances are examined and that appropriate measures are taken to maintain the integrity and safety of these substances.

Scope and Application

The Therapeutic Substances Act 1937 applies to therapeutic substances and their regulation within Australia. This Act applies to any person or entity involved in the importation, exportation, manufacture, or distribution of therapeutic substances. The Act regulates the importation and exportation of therapeutic substances, requiring licences and adherence to prescribed standards, labels, and examination procedures. It also empowers the Minister to declare substances as therapeutic and to approve overseas manufacturers. Notably, the Act does not apply to vaccines prepared from microscopic organisms intended for the treatment of the same individual or animal from which they were derived. The Act extends its reach to the Commonwealth level and may be further regulated by subordinate instruments such as regulations, which can prescribe additional requirements for licensing, fees, standards, and penalties. Additionally, the Act allows for delegation of powers by the Minister, which can be revoked at any time, ensuring flexibility in enforcement.

Key Provisions

The Therapeutic Substances Act 1937 (Act) sets out the framework for the control and regulation of therapeutic substances, which are substances used in the prevention or treatment of diseases in humans and animals. Key provisions of the Act include the declaration of therapeutic substances (section 7) and approved overseas manufacturers (section 8), both of which can be made by the Minister through notice in the Gazette. The Act also outlines the importation (section 9) and exportation (section 10) of therapeutic substances, including the requirement for these substances to conform to prescribed standards and bear specific labels. Furthermore, section 11 mandates that all imported or exportable therapeutic substances must be examined and analysed at laboratories designated by the Minister, and cannot be entered for home consumption or shipped until certified as compliant with the Act. The Act imposes obligations on parties such as requiring licences for the importation and manufacture of therapeutic substances, ensuring compliance with labelling and quality standards, and submitting substances for examination. Additionally, section 12 allows authorised officers to inspect licensed premises, equipment, and processes, and take samples of substances or materials. In the event of a serious disease outbreak or public health threat caused by therapeutic substances, the Governor-General can declare a state of emergency (section 13), and the Minister can issue orders for the destruction, withdrawal from sale, or cessation of preparation of specified substances. Failure to comply with such orders is an offence. The Act also criminalises the sale of therapeutic substances unlawfully imported (section 14), with a penalty of up to one hundred pounds. The Governor-General has the authority to make regulations under section 15, which include licensing, fees, standards for therapeutic substances, and penalties for offences against the regulations, not exceeding one hundred pounds. Offences under the Act can result in penalties, including fines of up to five hundred pounds, imprisonment for up to twelve months, or both, as specified in sections 13 and 14.

Area of Law: Medical Law
Instrument: Act
Concepts: Definitions & Interpretation; Commencement Provisions; Regulatory Standards; Licensing & Registration; Enforcement Powers; Penalty Provisions

Interactions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

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