Notice of Particulars of Revocation of Conformity Assessment Certificates

Administered by Department of Health, Disability and Ageing

Legislation au C2016G01028 In force Gazette

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COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

 

NOTICE OF PARTICULARS OF REVOCATION OF CONFORMITY ASSESSMENT CERTIFICATES UNDER SECTION 41EV OF THE THERAPEUTIC GOODS ACT 1989

I, Cheryl McRae, a delegate of the Secretary of the Department of Health for the purpose of section 41EV of the Therapeutic Goods Act 1989 (the Act), provide notice of the following particulars relating to the revocation of eight conformity assessment certificates under section 41ES of the Act:

(a)   By written notice of revocation dated 17 September 2015, a delegate of the Secretary notified Novapharm Research Australia Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00174.  The revocation was made under section 41ES of the Act in acordance with a written request for revocation from Novapharm Research Australia Pty Ltd dated 3 September 2015.  The revocation took effect on 17 September 2015, being the day that the written notice of revocation was given to Novapharm Research Australia Pty Ltd.

 

(b)  By written notice of revocation dated 10 March 2016, a delegate of the Secretary notified Australian Orthopaedic Fixations Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00221.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Australian Orthopaedic Fixations Pty Ltd dated 26 November 2015.  The revocation took effect on 11 March 2016, being the day that the written notice of revocation was given to Australian Orthopaedic Fixations Pty Ltd.

 

(c)   By written notice of revocation dated 15 March 2016, a delegate of the Secretary notified Smith & Nephew Inc of its decision to revoke the Conformity Assessment Certificate AU D00293.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Smith & Nephew Inc dated 9 December 2015.  The revocation took effect on 15 March 2016, being the day that the written notice of revocation was given to Smith & Nephew Inc. 

 

(d)  By written notice of revocation dated 10 March 2016, a delegate of the Secretary notified Imaxeon Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00050.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Imaxeon Pty Ltd dated 13 January 2016.  The revocation took effect on 10 March 2016, being the day that the written notice of revocation was given to Imaxeon Pty Ltd.

 

(e)   By written notice of revocation dated 15 March 2016, a delegate of the Secretary notified SDI Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00053.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from SDI Ltd dated 2 February 2016.  The revocation took effect on 15 March 2016, being the day that the written notice of revocation was given to SDI Ltd.

 

(f)    By written notice of revocation dated 15 March 2016, a delegate of the Secretary notified Nanosonics Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00207.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Nanosonics Ltd dated 9 March 2016.  The revocation took effect on 15 March 2016, being the day that the written notice of revocation was given to Nanosonics Ltd.

 

(g)   By written notice of revocation dated 27 May 2016, a delegate of the Secretary notified Biodental Technologies Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00113.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Biodental Technologies Pty Ltd dated 19 May 2016.  The revocation took effect on 31 May 2016, being the day that the written notice of revocation was given to Biodental Technologies Pty Ltd.

 

(h)  By written notice of revocation dated 9 June 2016, a delegate of the Secretary notified Alere Medical Company Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00348.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Alere Medical Company Ltd dated 6 June 2016.  The revocation took effect on 10 June 2016, being the day that the written notice of revocation was given to Alere Medical Company Ltd.

 

 

(Signed by)

 

Dr Cheryl McRae

Delegate of the Secretary

21 July 2016

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate therapeutic goods, including medicines, medical devices, and other related products, to ensure their safety, quality, and efficacy. This legislation addresses the need to manage the risks associated with therapeutic goods by establishing a framework for their regulation and oversight. The Therapeutic Goods Administration, operating under the Department of Health, is responsible for implementing the Act. The overarching policy objective is to protect public health by ensuring that therapeutic goods available in Australia meet acceptable standards of quality and safety. This Act provides the legal foundation for the regulation and control of therapeutic goods, including the ability to revoke conformity assessment certificates when necessary to protect public health, as demonstrated in the provided notice of revocations.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products such as medicines, medical devices, blood, and tissues. This Act governs the approval, manufacture, and sale of therapeutic goods, ensuring they meet quality, safety, and efficacy standards. It applies to entities and individuals involved in the production, importation, supply, or advertising of therapeutic goods within Australia. The Act extends to the entire Commonwealth, providing a national framework for the regulation of therapeutic goods. While the Act generally applies to all therapeutic goods, certain classes of goods such as blood and blood components are specifically excluded and regulated under different legislation. The Therapeutic Goods Act 1989 also allows for the creation of subordinate instruments to further refine and implement its provisions, such as codes and guidelines issued by the Therapeutic Goods Administration.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) includes provisions for the revocation of conformity assessment certificates, as specified in section 41ES. In this context, a conformity assessment certificate is a document issued under the Act that certifies a therapeutic good meets certain standards, enabling its registration in the Australian Register of Therapeutic Goods. Section 41EV of the Act provides for the revocation of such certificates upon request from the certificate holder or by the Secretary of the Department of Health, which is what is described in the notice of revocation. Each revocation notice details the specific certificate that was revoked, the date of the written notice, the date of the written request for revocation from the certificate holder, and the effective date of the revocation. The Act imposes certain obligations on entities holding a conformity assessment certificate, including maintaining compliance with the standards set out in the certificate. If an entity wishes to have their certificate revoked, they must submit a written request to the Secretary. Once the Secretary receives such a request, they are required to issue a written notice of revocation and effect the revocation on the date the notice is given. The certificate holders must also ensure that they have ceased using the certificate for the purposes of registering their goods if they have already done so. Breach of the obligations under the Act, such as continuing to use a revoked conformity assessment certificate for the registration of therapeutic goods, can result in significant consequences. While the specific civil or criminal penalties for breaches are not detailed in the notice of revocation, generally, under the Therapeutic Goods Act, breaches may lead to fines or imprisonment, depending on the severity of the offence. For example, under section 41H of the Act, the maximum penalty for using a revoked certificate could be a substantial fine, reflecting the seriousness of non-compliance with the regulatory requirements governing therapeutic goods. It is crucial for entities to adhere to the provisions of the Act to avoid these potential penalties.

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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.