Therapeutic Goods Information Specification 2009 Revocation Specification 2015

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was designed to establish and maintain a national system of controls for the quality, safety, efficacy/performance, and timely availability of therapeutic goods within Australia and for export. Administered by the Therapeutic Goods Administration (TGA) under the Department of Health, the Act aims to ensure that therapeutic goods meet necessary standards. Section 61 of the Act allows for the release of specified therapeutic goods information to certain entities and the public, enabling transparency and facilitating informed decision-making. The Therapeutic Goods Information Specification 2009 Revocation Specification 2015, made by a delegate of the Minister for Health under subsection 61(5D) of the Act, revokes the 2009 Specification to allow for its replacement with the updated Therapeutic Goods Information Specification 2015. This replacement is primarily to update references to expert committees and changes in the Act since 2009. The revocation and replacement aim to maintain the relevance and accuracy of the information available to the public.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, ensuring their quality, safety, efficacy, and timely availability within Australia and for export. This Act is administered by the Therapeutic Goods Administration, a part of the Department of Health. It encompasses a broad range of therapeutic goods, including medicines, medical devices, blood, and tissues. The Act applies to persons and entities involved in the manufacturing, importing, supplying, and advertising of these goods, as well as those engaged in clinical trials. Section 61 of the Act allows the Secretary to release specified kinds of therapeutic goods information to particular organisations and the public, with the power to create or revoke legislative instruments to facilitate this. The Act has a national jurisdictional reach, applying across all states and territories of Australia. The Therapeutic Goods Information Specification 2015 Revocation Specification 2015 revokes the 2009 Specification, facilitating the transition to the updated Therapeutic Goods Information Specification 2015. This revocation allows for the updating of references and provisions that have changed since 2009. The legislative instrument does not specify any exclusions or exemptions and operates within the confines of the Therapeutic Goods Act 1989.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) establishes a national system for the quality, safety, efficacy, performance, and timely availability of therapeutic goods used in or exported from Australia. The Therapeutic Goods Administration (TGA), part of the Department of Health, administers the Act. Under section 61 of the Act, the Secretary of the Department of Health can release specified kinds of therapeutic goods information to certain persons or organisations, including the World Health Organisation and state and territory authorities. Additionally, the Minister for Health can make a legislative instrument setting out other circumstances under which the Secretary can release therapeutic goods information to the public, and this power includes the ability to revoke the legislative instrument. The Therapeutic Goods Information Specification 2009 Revocation Specification 2015 (the Specification) is made by a delegate of the Minister under subsection 61(5D) of the Act. This instrument revokes the Therapeutic Goods Information Specification 2009 (the 2009 Specification), which allowed the Secretary to release a range of information, primarily relating to registered therapeutic goods, to the public. The purpose of the Specification is to facilitate the replacement of the 2009 Specification with the Therapeutic Goods Information Specification 2015, which updates references to the names of expert committees and provisions of the Act that have changed since 2009. The obligations and requirements imposed by the Act and the Specification on the parties and entities they govern include ensuring the quality, safety, efficacy, and timely availability of therapeutic goods. The Secretary is obligated to release therapeutic goods information under specified conditions, as outlined in section 61 of the Act, and any legislative instrument made under this section. The TGA and other relevant authorities must also ensure that the information released complies with the requirements set out in the Act and the Specification. There are no specific offences, penalties, or civil/criminal consequences outlined in the Explanatory Statement for breaches of the Therapeutic Goods Act 1989 or the Specification. However, it is understood that breaches of the Act and non-compliance with the Specification may result in enforcement actions by the TGA or other relevant authorities. The Therapeutic Goods Act 1989 provides for various penalties for breaches, which may include fines and imprisonment, depending on the nature and severity of the breach. The maximum penalties for offences under the Act can vary widely, depending on the specific provision breached and the circumstances of the offence. It is important for parties and entities governed by the Act and the Specification to ensure compliance to avoid potential enforcement actions and penalties.