National Security (Proprietary Medicines) Regulations

Legislation au C1942L00459 Regulations Not in force Legislative Instrument

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STATUTORY RULES.

1942. No. 459.

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REGULATIONS UNDER THE NATIONAL SECURITY ACT 1939-1940.*

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 National Security Act 1939-1940.

Dated this twentieth day of October, 1942.

(SGD) GOWRIE

Governor-General.

By His Excellency’s Command,

E. J. HOLLOWAY.

for and on behalf of the Minister of State for Defence.

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National Security (Proprietary Medicines) Regulations.

Citation.

1. These Regulations may be cited as the National Security (Proprietary Medicines) Regulations.

Administration.

2. These Regulations shall be administered by the Minister of State for Health.

Definitions.

3. In these Regulations, unless the contrary intention appears—

“medicine” includes any drug or preparation of any description whatsoever to be used, whether externally or internally, for the prevention, cure or relief of any malady, ailment, infirmity or disorder affecting human beings;

“proprietary medicine” means any medicine or compound of medicines prepared according to any formula, whether secret or not, which is held out by advertisement, label, or otherwise in writing or by broadcast by means of wireless telegraphy, as efficacious for the prevention, cure or relief of any malady, ailment, infirmity or disorder affecting human beings, or for increasing height, increasing or reducing weight or increasing personality or reproductive capacity;

* Notified in the Commonwealth Gazette on , 1942.

7282.—Price 5d. 25/13.10.1942.

“the Chairman of the Medical Equipment Control Committee” means the Chairman of the Medical Equipment Control Committee constituted under the National Security (Medical Co-ordination and Equipment) Regulations; and

“the Director-General” means the Director-General of Health.

Particulars of proprietary medicines to be furnished.

4.—(1.) On or before the fourteenth day of November, 1942, every person who manufactures a proprietary medicine, and the agent of any person who manufactures any proprietary medicine outside the Commonwealth, shall furnish to the Director-General—

(a) the name of the manufacturer and, if the proprietary medicine is manufactured outside the Commonwealth, the name of the agent in Australia;

(b) a full statement of the formula of the proprietary medicine;

(c) a sample of every container and of every label, package, leaflet, pamphlet or other printed matter (whether packed with the proprietary medicine or not) used in connexion with or relating to the proprietary medicine and a copy of the text of every advertisement relating to the proprietary medicine which was published in any newspaper between the fifteenth day of August, 1942, and the first day of September, 1942;

(d) a copy of the text of every statement relating to the proprietary medicine delivered by broadcasting by wireless telegraphy between the fifteenth day of August, 1942, and the first day of September, 1942;

(e) the amount or quantity of the proprietary medicine sold during the twelve months ended on the thirtieth day of June, 1942; and

(f) a statutory declaration that the statement of the formula furnished is true and correct in every particular, that the containers, labels, packages, leaflets, pamphlets and other printed matter and copies furnished are accurate and complete as required by this sub-regulation, and that all other statements made in accordance with this sub-regulation are true and correct in every particular.

(2.) Every person who, after the thirty-first day of October, 1942, commences to manufacture a proprietary medicine, or becomes the agent of any person who manufactures any proprietary medicine outside the Commonwealth—

(a) shall, within fourteen days after he commences to manufacture the proprietary medicine, or becomes such an agent, as the case may be, furnish to the Director-General particulars of the matters specified in paragraphs (a) and (b) of the last preceding sub-regulation, together with a statutory declaration that the particulars so furnished are true and correct in every particular; and

(b) shall, within fourteen days after the first user, or after the publication or delivery, as the case may be, furnish to the Director-General—

(i) a sample of every container and of every label, package, leaflet, pamphlet or other printed matter (whether packed with the proprietary medicine or not) used in connexion with or relating to the proprietary medicine;

(ii) a copy of the text of every advertisement relating to the proprietary medicine published in any newspaper; and

(iii) a copy of the text of every statement relating to the proprietary medicine delivered by broadcasting by wireless telegraphy,

together with a statutory declaration that the containers, labels, packages, leaflets, pamphlets and other printed matter and copies furnished are accurate and complete as required by this paragraph.

(3.) The formula referred to in paragraph (b) of sub-regulation (1.) of this regulation shall include an exact statement of the name and quantity of each substance included in the proprietary medicine and an exact statement of the percentage of the whole weight or volume of each substance in the proprietary medicine. In the case of a proprietary medicine containing bacteria or bacterial products, the formula shall contain the names of all bacteria which are used in its preparation and the number of each of the bacteria contained in any stated volume.

(4.) For the purposes of the last preceding sub-regulation—

(a) the name of any substance shall be either its botanical name or the name used in the British Pharmacopœia or the Pharmaceutical Codex issued by the General Council of Medical Education and Registration of the United Kingdom, and if the name of any substance is not a botanical name or is not included in the British Pharmacopœia or in the Pharmaceutical Codex, the name of the substance shall be the name under which it is commonly known;

(b) the quantity of any substance shall be expressed in the Imperial System of Apothecaries Measure or in the Metric System; and

Particulars of proprietary medicines not to be disclosed.

5. The Director-General shall not disclose any information furnished in pursuance of the last preceding regulation except to the Chairman of the Medical Equipment Control Committee or in accordance with written directions of the Minister.

Prohibition of manufacture of proprietary medicines.

6. The Minister may, by order, prohibit the manufacture or the sale of any proprietary medicine if he is satisfied that it has not the effects which are claimed on its behalf or does not satisfy the purposes for which it is sold, or that it is of a dangerous nature or is liable to produce abortion or miscarriage.

Canvassing, &c. of proprietary medicines prohibited.

7. A manufacturer or distributor of any proprietary medicine, or any person employed or authorized by a manufacturer or distributor of any proprietary medicine, shall not—

(a) canvass or solicit;

(b) employ any person to canvass or solicit,

any person for the purpose of inducing that person, to purchase, obtain, or use any proprietary medicine.

Restrictions on advertisements of proprietary medicines.

8.—(1.) A person shall not publish any statement, whether by way of advertisement or otherwise, to promote the sale of any proprietary medicine, which contains any statement other than—

(a) the trade name of the proprietary medicine;

(b) the nature of the proprietary medicine expressed in not more than ten words;

(d) the name of the manufacturer or distributor of the proprietary medicine and the address of his place of business.

(2.) Any person who—

(a) affixes or inscribes any statement on any thing whatsoever so as to be visible to persons being in or passing along any street, road, highway, pathway, public place or public conveyance;

(b) delivers, offers or exhibits any statement to any person being in or passing along any street, road, highway, pathway, public place or public conveyance;

(c) throws any statement into or upon any street, road, highway, pathway, public place or public conveyance, or into the area, yard, garden or enclosure of any house;

(d) exhibits any statement to public view in any house, shop or place;

(e) prints or publishes any statement in any newspaper;

(f) sells, offers for sale, shows or sends by post any statement to any person;

(g) otherwise than in the course of post, delivers to any person, or places in or upon any premises, any statement; or

(h) broadcasts by means of wireless telegraphy any statement, shall be deemed to have published that statement.

(3.) Nothing in this regulation shall prevent the display of any such statement upon any sign, hoarding or building where that statement was so displayed immediately prior to the commencement of these Regulations.

(4.) For the purposes of this regulation—

(a) the word “statement” includes any document, book or paper containing any statement; and

(b) a document consisting solely of a list of prices of commodities shall not be deemed to be a statement if it is distributed only to persons engaged in wholesale or retail trade in those commodities.

(5.) It shall be a defence to a prosecution under this regulation if the defendant proves that the statement was published in good faith for the advancement of medical, surgical or veterinary science, or was sent only to medical practitioners, veterinary surgeons or registered pharmacists for the purposes of their business.

Restrictions on production of proprietary medicines.

9.—(1.) The Minister may, after consultation with the Chairman of the Medical Equipment Control Committee, give directions in writing to any person—

(a) limiting the amount of any proprietary medicine which may be manufactured by that person;

(b) limiting the amount of any ingredient which may be included in any proprietary medicine manufactured by that person; or

(2.) Any person to whom any such direction is given shall comply therewith.

By Authority: L. F. Johnston, Commonwealth Government Printer, Canberra.

Overview

The National Security (Proprietary Medicines) Regulations 1942 were enacted under the authority of the National Security Act 1939-1940 to address the need for stringent control over the manufacturing and sale of proprietary medicines during a period of national security concern. The Regulations were made by the Governor-General in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, and are administered by the Minister of State for Health. The primary policy objective of these Regulations is to ensure that the proprietary medicines available in the market are safe, effective, and accurately represented, by imposing specific requirements on manufacturers and distributors to provide detailed information about their products and by restricting the types of claims that can be made in advertisements and other communications. These measures were necessary to prevent the dissemination of potentially harmful or misleading information about proprietary medicines during wartime, thereby protecting public health and maintaining national security.

Scope and Application

The National Security (Proprietary Medicines) Regulations 1942, made under the National Security Act 1939-1940, apply to any person involved in the manufacture of proprietary medicines within or outside the Commonwealth of Australia. These Regulations are administered by the Minister of State for Health and require manufacturers and their agents to furnish detailed information about the proprietary medicines they produce to the Director-General. This information includes the manufacturer's name, the medicine's formula, samples of containers and labels, advertising copies, and sales data. The Regulations also prohibit the disclosure of this information except under specific conditions, such as to the Chairman of the Medical Equipment Control Committee or pursuant to written directions from the Minister. The Minister has the authority to prohibit the manufacture or sale of any proprietary medicine deemed ineffective, dangerous, or harmful, and to restrict the advertising of these products to a limited set of permissible details. Additionally, the Regulations restrict the canvassing and distribution of proprietary medicines and empower the Minister to direct limitations on production quantities and ingredients used in the manufacture of proprietary medicines.

Key Provisions

The National Security (Proprietary Medicines) Regulations primarily address the administration and control of proprietary medicines during a period of national security concern. Under section 2, these Regulations are administered by the Minister of State for Health. The definition of terms such as "medicine" and "proprietary medicine" in section 3 sets the foundational understanding for the scope of the Regulations. Section 4 outlines the specific information that manufacturers and agents must provide to the Director-General, including details of the formula, samples, and sales figures, along with a statutory declaration affirming the accuracy of this information. Section 5 mandates that the Director-General must not disclose any furnished information except as permitted by the Regulations. The Regulations impose several obligations on the parties they govern. Firstly, manufacturers and agents of proprietary medicines are required to furnish detailed particulars to the Director-General, as outlined in section 4. This includes providing a comprehensive formula of the proprietary medicine, samples of all related containers and labels, and copies of advertisements and broadcasts. Furthermore, section 6 allows the Minister to prohibit the manufacture or sale of any proprietary medicine if it is found to be ineffective, dangerous, or misleading. Section 7 prohibits canvassing or soliciting for the sale of proprietary medicines, while section 8 restricts the content and methods of advertising such medicines, permitting only specific information to be published. Breaches of the Regulations can result in significant consequences. Under section 6, the Minister can prohibit the manufacture or sale of proprietary medicines that do not meet specified standards, potentially leading to criminal or civil penalties for non-compliance. Non-compliance with the information furnishing requirements in section 4 could also result in penalties, although specific penalties are not detailed in the Regulations. Additionally, the prohibitions on canvassing and advertising in sections 7 and 8 can lead to fines or other legal repercussions for those who violate these provisions, ensuring strict adherence to the Regulations.

Area of Law: National Security Law
Instrument: Regulation
Concepts: Definitions & Interpretation; Reporting & Disclosure Obligations; Prohibited Conduct

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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