Statutory Rules
1980 No. 368
REGULATION UNDER THE CUSTOMS ACT 19011
I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulation under the Customs Act 1901.
Dated this eleventh day of December 1980.
ZELMAN COWEN
Governor-General
By His Excellency’s Command,
JOHN MOORE
Minister of State for Business and Consumer Affairs
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AMENDMENT OF THE CUSTOMS (PROHIBITED IMPORTS)
REGULATIONS2
Eighth Schedule
The Eighth Schedule to the Customs (Prohibited Imports) Regulations is amended by inserting after Item 11 the following item:
“11A | Insulin syringes, being syringes, whether marked in insulin units or otherwise, that bear the word ‘insulin’, whether with or without any other words.”. |
1. Notified in the Commonwealth of Australia Gazette on 18 December 1980.
2. Statutory Rules 1956 No. 90 as amended to date. For previous amendments see Note 2 to Statutory Rules 1980 No. 71 and see also Statutory Rules 1980 Nos. 71, 78, 150 and 211.
Overview
The Statutory Rules 1980 No. 368, made under the Customs Act 1901, were enacted to address a gap in the regulation of prohibited imports, specifically targeting items that pose a risk to public health and safety. The regulation was introduced to prohibit the importation of insulin syringes, which were not previously covered under the existing legislative framework. This amendment was made by the Governor-General of the Commonwealth of Australia, acting on the advice of the Federal Executive Council. The policy objective behind this regulation was to enhance the safety and quality control of medical supplies entering the country by preventing the import of potentially unsafe or uncalibrated insulin syringes. The regulation was designed to ensure that all medical devices imported into Australia meet the necessary health and safety standards, thus protecting consumers from potential harm.
Scope and Application
The Statutory Rules 1980 No. 368, made under the Customs Act 1901, specifically address the regulation of prohibited imports into Australia. This legislative instrument amends the Customs (Prohibited Imports) Regulations by introducing new regulations that prohibit the importation of insulin syringes. The scope of this regulation applies to any person or entity attempting to import insulin syringes into Australia, regardless of their purpose or quantity. The amendment extends the list of prohibited items to include insulin syringes explicitly, whether they are marked in insulin units or bear the word "insulin" either alone or in combination with other words. This regulation has a national reach, applying uniformly across all states and territories of Australia. The regulation does not specify any exclusions or exemptions, and it imposes a prohibition without any stated thresholds. The regulation extends the application of the Customs Act by specifying a new category of prohibited imports, thus broadening the scope of controlled goods under the Customs (Prohibited Imports) Regulations.
Key Provisions
The Regulation, enacted under the Customs Act 1901, introduces specific amendments to the Customs (Prohibited Imports) Regulations, particularly focusing on the addition of a new item to the schedule of prohibited imports (s.2). This amendment explicitly prohibits the importation of insulin syringes, which are syringes marked with the word "insulin" in any form, whether alone or combined with other words (s.2). This inclusion serves to regulate the importation of medical supplies that are specifically intended for insulin use, ensuring compliance with health and safety standards.
Entities and individuals subject to the Customs Act 1901 must adhere to the new regulations by ensuring that any insulin syringes imported into Australia comply with the specified criteria. This means that any attempt to import insulin syringes must be scrutinised to confirm that they do not bear the word "insulin" in any manner, as this would render them non-compliant with the new regulations (s.2). Customs officials are required to enforce these regulations, and importers must declare accurately the contents of their shipments to avoid any breaches.
Failure to comply with the new regulations could result in significant legal consequences. Under the Customs Act 1901, unauthorised importation of prohibited items can lead to both civil and criminal penalties. Civil penalties may include fines, while criminal penalties could involve imprisonment, reflecting the seriousness of circumventing customs regulations. The exact penalties would be determined based on the severity of the breach and any previous infractions, with the potential for maximum penalties as prescribed by the Act. It is crucial for importers to be fully aware of these obligations and to ensure that their practices align with the regulatory requirements to avoid facing such consequences.