Customs (Prohibited Imports) Regulations (Amendment)

Administered by Attorney-General's Department

Legislation au F1996B03771 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

CUSTOMS ACT 1901

CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT)

STATUTORY RULES 1988 NO. 374

ISSUED BY THE AUTHORITY OF THE MINISTER OF STATE FOR SCIENCE, CUSTOMS AND SMALL BUSINESS

These Statutory Rules give the Secretary of the Department of Community Services and Health the power to authorise other officers to exercise certain of the numerous administrative functions entrusted to the Secretary under the Customs (Prohibited Imports) Regulations (the Regulations) in relation to the importation of therapeutic goods.

Recent advice from the Attorney-General’s Department was to the effect that in the absence of an express provision in the Regulations, the Secretary had no general power to delegate his powers under the Regulations, nor authorise another officer to exercise his powers on his behalf.

In the interests of administrative convenience and efficiency therefore, the amendments to the Regulations, as detailed below, to so delegate the Secretary’s powers have been made. The Statutory Rules ensure that the same avenues of appeal under regulation 5G which exist in relation to the decisions of the Secretary, apply in relation to decisions of authorised persons.

Details of the Regulations are as follows:

Regulation 1: is a machinery provision which defines the Customs (Prohibited Imports) Regulations as the “Principal Regulations” for the purposes of these Statutory Rules.

Regulation 2: amends regulation 5A of the Principal Regulations by inserting a new subregulation 5A(8) which defines the term “authorised person” to mean, a person authorised in writing by the Secretary of the Department of Community Services and Health to be an authorised person for the purposes of Regulation 5A. This definition is similar to that used in other Customs (Prohibited Imports) and Customs (Prohibited Exports) Regulations. (See for instance regulation 4C of the Customs (Prohibited Imports) Regulations).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” or “or authorised person”, as appropriate, to be inserted after “Secretary of the Department of Community Services and Health” in subregulations 5A(1), 5A(3) and 5A(4).


This allows persons authorised by the Secretary to grant permissions to import therapeutic substances. (See Regulation 8 for the right of appeal against a decision of an authorised person).

Regulation 3: amends regulation 5B of the Principal Regulations by inserting a new subregulation 5B(5) which defines the term “authorised person” for the purposes of regulation 5B. (The definition is the same as that used in regulation 5A, for which comment is made in Regulation 2).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” or “or authorised person”, as appropriate, to be inserted after “Secretary of the Department of Community Services and Health” in subregulations 5B(1) and 5B(2), where first occurring, paragraphs 5B(2)(a), and (b), and subregulation 5B(2A), where first occurring and paragraph 5B(2A)(b), wherever occurring, and subregulations, 5B(2C) and 5B(4).

This allows persons authorised by the Secretary to grant applicants a licence to import therapeutic substances. (See Regulation 8 for the right of appeal against a decision of an authorised person).

Regulation 4: amends regulation 5C of the Principal Regulations by inserting in subregulation 5C(1) a definition of “authorised person” for the purposes of regulation 5E. (The definition is the same as that used in regulation 5A, for which comment is made in Regulation 2).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” to be inserted after “Secretary of the Department of Community Services and Health” in subregulation 5C(4).

This allows persons authorised by the Secretary to approve the disposal of designated therapeutic substances. (See Regulation 8 for the right of appeal against a decision of an authorised person).

Regulation 5: amends regulation 5D of the Principal Regulations by inserting a new subregulation 5D(6) which defines the term “authorised person” for the purposes of regulation 5E. (The definition is the same as that used in regulation 5A, for which comment is made in Regulation 2).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” to be inserted after “Secretary of the Department of Community Services and Health” in subparagraph 5D(1)(b)(i).


This amendment is consequential upon regulation 5E (which deals with the disposal of designated therapeutic substances) as subparagraph 5D(1)(b)(i) provides that it is a condition of a licence granted to a person under regulation 5B that the person shall not dispose of certain designated therapeutic substances without the approval of the Secretary, or now, an authorised person. (See Regulation 8 for the right of appeal against a decision of an authorised person).

Regulation 6: amends regulation 5E of the Principal Regulations by inserting a new subregulation 5E(6) which defines the term “authorised person” for the purposes of Regulation 5E. (The definition is the same as that used in regulation 5A, for which comment is made in Regulation 2).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” or “or authorised person” as appropriate, to be inserted in subregulations 5E(2), 5E(3), 5E(3A), and 5E(4), where first, second, third, fourth and sixth occurring.

This amendment allows persons authorised by the Secretary to approve the disposal of designated therapeutic substances. (See Regulation 8 for the right of appeal against a decision of an authorised person).

Regulation 7: amends regulation 5F of the Principal Regulations by inserting a new subregulation 5F(4) which defines the term “authorised person” for the purposes of regulation 5F. (The definition is the same as that used in regulation 5A, for which comment is made in Regulation 2).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” or “or authorised person” as appropriate, to be inserted in subregulation 5F(1), where first and second occurring, paragraphs 5F(2)(a) and (b) and subregulation 5F(3), where first and second occurring.

This amendment ensures that when an authorised person makes certain decisions, such as refusing a permission to import therapeutic substances, that person has an obligation to furnish a statement of reasons.

Regulation 8: amends regulation 5G of the Principal Regulations by inserting a new subregulation 5G(10) which defines the term “authorised person” for the purposes of regulation 5A, 5B, or 5E. (The definition is the same as that used in regulation 5A, for which comment is made in Regulation 2).

• The Schedule to these Statutory Rules must be read in conjunction with this regulation, as it provides for the words “or an authorised person” or “or authorised person” as appropriate, to be inserted in subregulation 5G(1), 5G(2),

5G(3), 5G(4), where first occurring, 5G(5), where first, second and third occurring, and 5G(8), where first, second and third occurring.

This amendment ensures that a person who is aggrieved by certain decisions of an authorised person, for example, to refuse a person permission to import therapeutic substances, may request the Minister of State for Community Services and Health to review the decision.

Regulation 9: provides that further amendments to the Principal Regulations are set out in the Schedule to these Statutory Rules.

The Schedule: amends regulations 5A, 5B, 5C, 5E, 5F and 5G of the Principal Regulations by inserting the words “or an authorised person” or “or authorised person”, as appropriate, after certain references to the “Secretary of the Department of Community Services and Health”. These amendments are discussed further under the respective explanations to the regulations themselves.

Overview

The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1988 were enacted to address the administrative challenges faced by the Secretary of the Department of Community Services and Health in managing the importation of therapeutic goods. This set of rules was issued under the authority of the Minister of State for Science, Customs and Small Business to improve the efficiency and convenience of administrative processes. The primary objective of these amendments was to enable the Secretary to delegate specific powers to authorised officers, ensuring that decisions regarding the importation of therapeutic goods could be made by individuals other than the Secretary himself. This delegation aimed to streamline the process without compromising the authority and oversight traditionally held by the Secretary. The Statutory Rules ensure that any decision made by an authorised officer can be appealed in the same way as a decision made by the Secretary, maintaining a consistent standard of review and accountability.

Scope and Application

The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1988 No. 374, issued under the authority of the Minister of State for Science, Customs and Small Business, amend the Customs (Prohibited Imports) Regulations in relation to the importation of therapeutic goods. These amendments address the delegation of powers held by the Secretary of the Department of Community Services and Health, allowing for the authorisation of other officers to exercise certain administrative functions concerning the import of therapeutic substances. The primary objective of these amendments is to enhance administrative efficiency by enabling the Secretary to delegate specific duties to authorised persons, thereby facilitating the import process while ensuring compliance with the regulations. The amendments include the insertion of new subregulations defining "authorised person" and modifying existing subregulations to include authorised persons in decision-making processes, such as granting permissions, issuing import licences, and approving the disposal of designated therapeutic substances. Additionally, these Statutory Rules ensure that authorised persons have obligations, such as providing statements of reasons for decisions, and that aggrieved parties can appeal decisions made by authorised persons to the Minister of State for Community Services and Health. The scope of these regulations is national, impacting entities and individuals involved in the importation of therapeutic goods within Australia.

Key Provisions

The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1988 No. 374 primarily focus on delegating certain administrative functions to authorised persons under the Customs (Prohibited Imports) Regulations. These functions relate to the importation of therapeutic goods. Regulation 2 introduces a new subregulation 5A(8) defining an “authorised person” as someone authorised in writing by the Secretary of the Department of Community Services and Health (Regulation 2). Regulation 3 similarly defines an “authorised person” for regulation 5B, while Regulation 4 provides the definition for regulation 5E. Regulations 5 and 6 then insert “or an authorised person” into various subregulations of the Principal Regulations, allowing authorised persons to approve the disposal of designated therapeutic substances (Regulations 5 and 6). Regulation 7 requires authorised persons to provide a statement of reasons for certain decisions, such as refusing a permission to import (Regulation 7). Finally, Regulation 8 allows aggrieved persons to request a review of an authorised person’s decision by the Minister of State for Community Services and Health (Regulation 8). The Act imposes several obligations on the parties and entities it governs. Firstly, the Secretary must formally authorise certain officers to act on his behalf, thereby delegating specific administrative functions related to the importation of therapeutic goods (Regulation 2). Authorised persons must adhere to the same administrative standards and processes as the Secretary in exercising their delegated powers (Regulations 2-8). They must provide clear statements of reasons for their decisions (Regulation 7) and ensure that their actions comply with the Regulations and any relevant laws. The aggrieved parties also have the right to appeal certain decisions made by authorised persons, maintaining a system of checks and balances (Regulation 8). Failure to comply with the provisions of the Regulations may result in various civil and criminal consequences. While the Act does not explicitly detail specific offences or penalties, breaches of the Regulations could potentially lead to legal action. Authorised persons who fail to provide adequate statements of reasons or make decisions outside the scope of their authority could face administrative penalties or legal challenges. Additionally, any improper importation of therapeutic goods facilitated by non-compliance could result in further legal consequences, including fines or imprisonment, under the broader Customs Act 1901. The exact penalties would depend on the nature and severity of the breach, as well as any relevant case law.

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Administrative Law
Customs Law
Health Law
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Regulation
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