STATUTORY RULES.
1959. No. 14.
REGULATIONS UNDER THE THERAPEUTIC SUBSTANCES ACT 1953.*
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 Therapeutic Substances Act 1953.
Dated this 28th day of February, 1959.
W. J. Slim
Governor-General.
By His Excellency’s Command,
(Sgd.) Donald A. Cameron
Minister of State for Health.
Amendments of the Therapeutic Substances Regulations.†
1. After regulation 11 of the Therapeutic Substances Regulations the following regulation is inserted:—
Establishment of the National Biological Standards Laboratory.
“11a.—For the purposes of these Regulations, the Minister may establish a laboratory to be known as the National Biological Standards Laboratory.”.
Examination, &c., and certificates of official analysts.
2. Regulation 14 of the Therapeutic Substances Regulations is amended by inserting in sub-regulation (1.), after the words “these Regulations”, the words “or at the National Biological Standards Laboratory established under regulation 11a of these Regulations”.
Review of examination, &c., of official analyst.
3. Regulation 15 of the Therapeutic Substances Regulations is amended by omitting from sub-regulation (2.) all the words after the word “agreement,” and inserting in their stead the words “to an analyst nominated by the Director-General.”.
* Notified in the Commonwealth Gazette on 5th March, 1959.
† Statutory Rules 1956, No. 4, as amended by Statutory Rules 1956, No. 113; 1957, No. 64; and 1958, No. 21.
By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.
8652/58.—Price 3d. 9/31.12.1958.
Overview
The Statutory Rules of 1959, No. 14, were enacted under the Therapeutic Substances Act 1953, aiming to amend the Therapeutic Substances Regulations. This legislative instrument was introduced to address the need for a more robust and centralised framework for the examination and certification of therapeutic substances in Australia. The Regulations were made by the Governor-General in accordance with the advice of the Federal Executive Council, reflecting a policy objective to enhance the quality control and standardisation of therapeutic substances through the establishment of the National Biological Standards Laboratory. This laboratory, as specified in the Regulations, was to be overseen by the Minister and would play a crucial role in ensuring that therapeutic substances met the necessary standards for safety and efficacy.
Scope and Application
The Therapeutic Substances Regulations 1959, issued under the Therapeutic Substances Act 1953, apply to the regulation of therapeutic substances across the Commonwealth of Australia. The regulations pertain to entities and individuals involved in the production, importation, supply, and analysis of therapeutic substances. These include pharmaceutical products and biological materials subject to quality and safety standards to ensure they are fit for therapeutic use. The regulations extend to the establishment of the National Biological Standards Laboratory, which plays a critical role in setting standards and conducting analyses. Furthermore, the regulations govern the qualifications and conduct of official analysts who perform examinations and issue certificates to ensure compliance with therapeutic standards. These regulations are applicable nationally, with the authority to establish the National Biological Standards Laboratory and set standards for therapeutic substances exercised by the Minister. The scope of the regulations can be extended through subordinate instruments, providing flexibility to adapt to new scientific and therapeutic developments.
Key Provisions
The main operative sections of the Statutory Rules 1959 No. 14 include the establishment of the National Biological Standards Laboratory (Regulation 11a), the expansion of where examinations can take place (Regulation 2), and the alteration of the review process for examinations by official analysts (Regulation 3). Regulation 11a allows the Minister to establish a laboratory known as the National Biological Standards Laboratory. Regulation 2 amends the existing Regulation 14 to allow examinations to be conducted not only under the original regulations but also at the newly established National Biological Standards Laboratory. Regulation 3 modifies Regulation 15 by changing the review process for examinations conducted by official analysts, shifting the responsibility from an agreement to a nomination by the Director-General.
These Regulations impose several obligations and requirements on the parties involved. The Minister is tasked with establishing the National Biological Standards Laboratory as per Regulation 11a. This laboratory must meet the standards and criteria set forth in the Therapeutic Substances Act 1953. Furthermore, examinations of therapeutic substances can now be carried out at this new laboratory in addition to the previously designated locations, as per Regulation 2. Regulation 3 alters the review process, requiring that the Director-General nominate an analyst to review the examinations conducted by official analysts, thereby ensuring a consistent and authoritative oversight mechanism.
The Regulations also address potential breaches and the consequences thereof, although specific penalties are not detailed within the text provided. Generally, under the Therapeutic Substances Act 1953, breaches of the regulations can lead to both civil and criminal penalties. Civil penalties may include fines, while criminal penalties can encompass imprisonment, reflecting the seriousness with which the legislation treats non-compliance. The exact penalties would depend on the specific nature and severity of the breach, as outlined in the main Act and related regulations. It is essential for parties to adhere to these requirements to avoid legal repercussions.