Overview

The Therapeutic Goods (Manufacturing Principles) Determination No 2 of 2002, enacted by the Commonwealth of Australia, amends the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 1999 to update the principles governing the manufacturing of therapeutic goods. This legislative instrument was introduced to address the need for more current and comprehensive guidelines in the manufacturing of medicines, ensuring they meet the necessary standards to protect public health. It was enacted by Terry Slater, acting as a delegate of the Parliamentary Secretary to the Minister for Health and Ageing under the authority vested in him by section 36 of the Therapeutic Goods Act 1989. The policy objective of this amendment is to ensure that the manufacture of medicines complies with the most recent good manufacturing practices, as outlined in the Australian Code of Good Manufacturing Practice for Medicinal Products. This Determination applies to all medicines except those exempted from the Therapeutic Goods Act 1989, sunscreens, blood products, and human tissue.

Scope and Application

The Therapeutic Goods (Manufacturing Principles) Determination No 2 of 2002 amends and updates the manufacturing principles for medicines under the Therapeutic Goods Act 1989. It applies to the manufacture of all medicines except those that are exempt from compliance with Part 4 of the Act, sunscreens, blood and blood components, and human tissue. The determination mandates that medicines must be manufactured in accordance with the Australian Code of Good Manufacturing Practice for Medicinal Products, dated 16 August 2002, with transitional provisions allowing compliance with the previously listed manufacturing standards for the first twelve months following the gazette of the determination. This legislative instrument extends the application of the Act through the setting of specific manufacturing principles and compliance requirements for therapeutic goods within the Commonwealth.

Key Provisions

The Therapeutic Goods (Manufacturing Principles) Determination No 2 of 2002 (MP2/2002) amends the previous manufacturing principles by removing references to certain codes and introducing new principles for the manufacture of medicines. Clause 1 of this Determination removes outdated references to the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Products (August 1990), the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Gases (July 1992), and the Investigational Medicinal Products Code of GMP. Clause 2 introduces new manufacturing principles that must be observed for the manufacture of medicines, which are detailed in Clause 5 of this Determination. This Determination applies to all medicines except those exempted from the Therapeutic Goods Act 1989, sunscreens, blood, blood components, plasma, and human tissue. Under Clause 7, medicines to which this Determination applies must be manufactured in compliance with the Australian Code of Good Manufacturing Practice For Medicinal Products dated 16 August 2002. This requirement ensures that the manufacturing of these medicines adheres to the most current and relevant standards. Clause 8 allows for a transition period during which manufacturers can either comply with the new manufacturing standards listed in Clause 1 or with the Code, providing some flexibility during the initial phase of implementation. The obligations imposed by this Determination are clear: manufacturers of medicines, except those exempted or specified, must ensure their products are manufactured according to the principles set out in the Code. This includes adhering to the new manufacturing standards introduced by Clause 1 of this Determination. The transition period provided in Clause 8 allows manufacturers to adjust their processes, ensuring a smooth implementation of the new standards. Failure to comply with the manufacturing principles and standards set out in this Determination can result in legal consequences. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for non-compliance. The specific penalties may vary depending on the nature and severity of the breach, but they can include fines and imprisonment. The exact penalties are detailed within the Act itself, which governs the broader scope of therapeutic goods regulation in Australia.