Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00641 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Therapeutic Goods Act 1989

 

Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018

 

The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in, or exported from, Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, is responsible for administering the Act.

 

The Therapeutic Goods Amendment (2017 Measures No.1) Act 2018 (the Amendment Act) recently amended the Act to, among other things (including in particular to support the implementation of several key recommendations of the Expert Panel Review of Medicines and Medical Device Regulation (the Review) agreed to by the Australian Government), provide greater clarity in relation to the processing of applications for the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (the Register) following the decision of the Federal Court in Nicovations Australia Pty Ltd v Secretary of the Department of Health [2016] FCA 394 (Nicovations).

 

The Court in Nicovations found that the process adopted by the Department (through the TGA) in not progressing the processing of applications that did not satisfy preliminary requirements was not consistent with the Court’s construction of the operation of section 23 of the Act. 

 

These preliminary requirements (which include, for example, requirements that an application has been made in accordance with the appropriate approved form for the type or subset of goods involved, and has provided the necessary type and amount of supporting information needed to evaluate the application), are designed to enable the effective management of resources by the Department in the review of products, and to create certainty for sponsors as to the status of their products.  A full evaluation process represents a considerable investment in, and use of, resources. As resources are finite, if an inaccurate or deficient application must nevertheless be fully evaluated, this could cause delay in the processing of other applications.

 

As such, the Amendment Act introduced measures to make it clear that an application for the inclusion of a medicine, biological or medical device in the Register must meet certain preliminary requirements before the Secretary is required to evaluate the application, and that the Secretary has the power to refuse an application prior to evaluating it if the application does not meet the requirements for a proper application.

 

In particular, the Amendment Act introduced new sections 23A and 23B to the Act. Section 23A provides for the Secretary, by notifiable instrument, to specify different classes of therapeutic goods for the purposes of section 23B. Section 23B sets out the preliminary assessment requirements relating to applications for the registration of therapeutic goods (principally prescription medicines, over the counter medicines and registrable complementary medicines), and the listing of medicines under section 26AE of the Act (listable medicines which are to be evaluated by the Secretary in relation to their efficacy). These requirements include a requirement that the application be accompanied by supporting information that is of a kind determined under subsection 23B(9), and that the information is in a form determined under subsection 23B(10).

 

Subsection 23B(9) of the Act relevantly provides that the Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph 23B(2)(d)(i) of the Act to a class of therapeutic goods that is specified under section 23A of the Act.

 

Subsection 23B(10) of the Act relevantly provides that the Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph 23B(2)(d)(ii) to a class of therapeutic goods that is specified under section 23A.

 

Under section 23A, complementary medicines are specified as a class of therapeutic goods. The Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018 (the Determination) is made under subsections 23B(9) and (10) for the purpose of the application of subparagraphs 23B(2)(d)(i) and (ii) to applications to register goods of that class.

                                                                                                                                                                                                                                              

Before the commencement of the Amendment Act, requirements relating to the kind and form of information that was required to accompany an application for registration were imposed under section 23 of the Act. While that section was repealed and replaced by the Amendment Act, the nature of the requirements imposed by the Determination is similar to those that were previously imposed under the former section 23. The information required to accompany an application is necessary to enable the Secretary to undertake a full evaluation of the application in accordance with section 25 of the Act, and is information that sponsors would be expected to have available when they apply for registration. The form in which the information must be provided is appropriate to ensuring that the evaluation can be undertaken efficiently.

 

The Determination itself is minor and machinery in nature, as the requirements imposed are similar to those in place before the commencement of the Amendment Act. Accordingly no specific consultation has been undertaken on the content of the Determination.

 

Details of the Determination are set out in Attachment A.

 

The Determination is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

                                                                                                                                                                                   

The Determination is a disallowable legislative instrument and commenced on the day after it was registered.

 


Attachment A

 

Details of the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018

                                                                                                                                                                                                                                                                                                                                                                     

Section 1 – Name

 

This section provides that the name of the Determination is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018.

 

Section 2 – Commencement

 

This section provides that the Determination commences on the day after it is registered.

 

Section 3 – Definitions

 

This section provides definitions for certain terms used in the Determination that are not otherwise defined in the Act. 

 

Section 4 – Applications to which this instrument applies

 

This section provides that the Determination applies to applications to register complementary medicines.

 

Section 5 – Kind of information

 

This section specifies the kind of information that must be provided with an application to which the instrument applies. The information is the information specified in various specified documents published by the TGA before the commencement of the Determination. Copies of those documents are available on the TGA’s website, free of                                                                                                                                                                                                                                                                                      charge, and the Determination includes information in relation to the intended manner of incorporation of each of these documents.

 

Section 6 – Form of information

 

This section specifies the form in which any required information must be provided.  The information must be provided in a dossier consistent with the TGA document titled General dossier requirements, version 1.3, published in March 2018, a copy of which is available on the TGA’s website, free of charge.

 

 


Attachment B

 

Statement of compatibility with human rights

 

This statement is prepared in accordance with subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018

 

The Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018 is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of legislative instrument

 

This instrument is made under subsections 23B(9) and (10) of the Therapeutic Goods Act 1989 (the Act) by a delegate of the Minister for Health.  The purpose of the Determination is to set out the kind of information that must accompany an application for the registration of a complementary medicine, and the form in which that information must be provided.

 

The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 amended the Act to provide for the preliminary assessment of applications for registration of therapeutic goods. Under paragraph 23B(2)(d) of the Act as amended an application must be accompanied by information that is of a kind determined under subsection 23B(9) of the Act and in a form determined under subsection 23B(10) of the Act. The only persons on whom requirements are imposed are applicants for the registration of therapeutic goods (principally, these are prescription medicines, over the counter medicines and registrable complementary medicines). The requirements are reasonably adapted to the need to ensure that the quality, safety and efficacy of the goods have been satisfactorily established.

 

Human rights implications

 

As this instrument does not introduce any requirements other than those outlined above, it would not appear to engage any of the applicable rights or freedoms.

 

Conclusion

 

This instrument is compatible with human rights as it does not raise any human rights issues.

 

 

Dr Larry Kelly, 

Delegate of the Secretary of the Department of Health

 

Overview

The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018, which was enacted by the Parliament of Australia, introduced amendments to the Therapeutic Goods Act 1989 to address issues arising from the Federal Court decision in Nicovations Australia Pty Ltd v Secretary of the Department of Health [2016] FCA 394. This decision highlighted inconsistencies in the processing of applications for the registration of therapeutic goods, leading to delays and resource mismanagement. The 2018 Amendment Act aimed to provide clarity by establishing preliminary requirements that applications must meet before evaluation, allowing the Secretary to refuse applications that do not meet these requirements. The Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018, made under the authority of the amended Act, specifies the kind and form of information required for applications to register complementary medicines. This Determination ensures that the evaluation process is efficient and that resources are effectively managed, while also providing certainty to sponsors regarding the status of their applications. The Determination is compatible with human rights, as it imposes requirements only on applicants and does not engage any applicable rights or freedoms.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA), establishes a national system for the regulation of therapeutic goods, including complementary medicines, to ensure their quality, safety, efficacy, and timely availability. The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 introduced new provisions aimed at clarifying the application process for registration in the Australian Register of Therapeutic Goods, particularly in light of a Federal Court decision that questioned the TGA's previous approach. This amendment ensures that applications for the registration of therapeutic goods, such as prescription medicines, over-the-counter medicines, and complementary medicines, must meet preliminary requirements before the Secretary evaluates them. Specifically, the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018 specifies the kind and form of information that must accompany an application for the registration of complementary medicines. The Determination applies to applications for the registration of complementary medicines and mandates that the required information be provided in a form consistent with the TGA's General dossier requirements document. The instrument is compatible with human rights as it does not impose any additional requirements beyond those necessary for ensuring the quality, safety, and efficacy of therapeutic goods.

Key Provisions

The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (Amendment Act) amended the Therapeutic Goods Act 1989 (the Act) to provide clarity regarding the processing of applications for the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (section 23A and section 23B). The Act now requires that certain preliminary requirements be met before an application can be evaluated. Specifically, the Secretary may, by notifiable instrument, specify different classes of therapeutic goods for the purposes of section 23B (section 23A). Section 23B sets out the preliminary assessment requirements relating to applications for the registration of therapeutic goods, which include a requirement that the application be accompanied by supporting information that is of a kind determined under subsection 23B(9), and that the information is in a form determined under subsection 23B(10). The Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018 (the Determination) specifies the kind of information and form in which the information must be provided for complementary medicines. The Determination requires that applications to register complementary medicines must be accompanied by information specified in various specified documents published by the Therapeutic Goods Administration (TGA) before the commencement of the Determination, and the information must be provided in a dossier consistent with the TGA document titled General dossier requirements, version 1.3, published in March 2018. The Determination imposes obligations on applicants for the registration of complementary medicines. Applicants must ensure that the application is accompanied by the required information, in the specified form, as determined by the Secretary under section 23B(9) and (10) of the Act. This requirement is intended to enable the Secretary to undertake a full evaluation of the application in accordance with section 25 of the Act, and to ensure that the evaluation can be undertaken efficiently. The obligation to provide the required information is reasonably adapted to the need to ensure that the quality, safety, and efficacy of the goods have been satisfactorily established. Failure to comply with the requirements of the Determination may result in the Secretary refusing the application prior to evaluation. There are no specific offences or penalties outlined in the Determination itself. However, the Act contains provisions for the imposition of civil and criminal penalties for breaches of the Act and its regulations. For example, section 36AA of the Act provides that a person who contravenes a direction under the Act is liable to a penalty not exceeding the greater of three times the benefit obtained, $22,200, or, in the case of a continuing failure to comply, $1,110 for each day that the failure continues. Section 36AB of the Act provides that a person who contravenes a direction under the Act is liable to imprisonment for a term not exceeding two years, or to a fine not exceeding $121,500, or both. These penalties apply to breaches of the Act and its regulations, rather than the Determination itself.

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