EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Restricted Medicine Specification 2011
The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act and associated Regulations under the Act.
Subsections 3(2A) and (2B) of the TG Act authorise the Minister for Health and Ageing (the Minister), by legislative instrument, to specify medicines and classes of medicine for the purposes of paragraphs (a) and (b), respectively of the definition of restricted medicine in subsection 3(1) of the TG Act. Restricted medicine means a medicine specified in an instrument under subsection 3(2A) or medicine included in a class of medicine specified in an instrument under subsection 3(2B).
Paragraph 23(2)(b) of the TG Act requires an application lodged under section 23 for the registration of a restricted medicine to be accompanied by a draft product information document for the medicine in the form approved by the Secretary of the Department of Health and Ageing under section 7D. An application for the registration of a restricted medicine that is not accompanied by the product information document is not an effective application under section 23 of the TG Act and will not be considered for evaluation.
A product information document in relation to therapeutic goods means a document containing information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods (subsection 3(1) of the TG Act). By reason of subparagraph 25(1)(da)(i) the product information provided by the applicant is one of the matters that is evaluated for the purpose of determining whether the medicine the subject of the application should be approved for registration in the Australian Register of Therapeutic Goods. If the decision of the Secretary or her delegate is that the medicine is to be registered, subparagraph 25(4)(d)(ia) requires that the applicant be notified in writing of the product information that is approved in relation to the medicine.
The purpose of this instrument is to specify medicines or classes of medicine for the purposes of the definition of restricted medicine in subsection 3(1). This instrument is to be cited as the Restricted Medicine Specification 2011 and commences on the day after it is registered in the Federal Register of Legislative Instruments.
The medicines or classes of medicine that are specified as restricted medicines are set out in Schedule 1 to the instrument. The effect of the inclusion of a medicine or classes of medicine in Schedule 1 is that an applicant for registration of any of the medicines so listed is required to provide a draft product information document as part of the application for registration package.
Schedule 1 specifies medicines and classes of medicine:
(a) that are included in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 (the Regulations) other than in item 1(b) of Part 1 and item 14; and
(b) that contain a substance included in Schedule 3 to the current Poisons Standard.
The medicines set out in Part 1 of Schedule 10 to the Regulations include those that contain a substance mentioned in Schedules 4 (prescription only medicines), 8 (controlled drug) or 9 (prohibited substance) of the current Poisons Standard (which because they are considered high risk have restrictions on the way they can be supplied), vaccines, allergens, and immunoglobulins. Schedule 3 substances are those that can be supplied without a prescription but only by a pharmacist.
Item 1(b) in Part 1 of Schedule 10 is excluded as it refers to substances that are not mentioned in any of Schedules 4, 8 or 9 but which meet the criteria for mention in those Schedules. Were an application for registration to be made for such a substance and either at any time during the evaluation process the substance is included in any of those Schedules or the Secretary otherwise comes to the view that it would be appropriate for a product information document to be approved as part of the registration process for that medicine, the Secretary can notify the applicant to supply a product information document in the approved form. The same applies in relation to an application for a medicine that contains a substance which is not in Schedule 3 but meets the criteria for mention in Schedule 3.
Item 14 in Part 1 of Schedule 10 to the Regulations (which currently refers to therapeutic goods referred for evaluation to the Office of Prescription Medicines of the TGA) is excluded because therapeutic goods would only be referred once an application for registration has already been lodged. Item 14 could not therefore apply to a medicine at the time an application for registration for the medicine was being made.
The Restricted Medicine Specification 2011 is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).
The requirements set out in this instrument will have minimal regulatory impact in general as they reflect the TGA’s current administrative arrangements for the lodgement and approval of product information documents for prescription and other medicines.
The making of this instrument did not involve public consultation. However, the amendments to the TG Act implemented by Schedule 1A of the Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010, which include provisions relating to the requirements for a product information document, involved consultation with the Generic Medicines Industry Association (GMiA) and Medicines Australia. As noted above, the requirements reflect current administrative arrangements.
Overview
The Therapeutic Goods Act 1989 was enacted to establish a regulatory framework ensuring the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The Act aims to provide a comprehensive system of controls for therapeutic goods, whether they are used domestically or exported, overseen by the Therapeutic Goods Administration (TGA). The Restricted Medicine Specification 2011 was introduced to specify medicines or classes of medicine for the purposes of the definition of restricted medicine under the Therapeutic Goods Act 1989. This legislative instrument, overseen by the Minister for Health and Ageing, is intended to align with the existing administrative practices of the TGA concerning the registration of restricted medicines by ensuring that appropriate product information documents are submitted with registration applications. The policy objective is to maintain high standards in the therapeutic goods market by mandating detailed information on the safe and effective use of these medicines.
Scope and Application
The Therapeutic Goods Act 1989, as amended, provides a framework for the regulation of therapeutic goods in Australia, ensuring their quality, safety, efficacy, and timely availability. The Act allows the Minister for Health and Ageing to specify certain medicines and classes of medicines as restricted, which requires an application for their registration to be accompanied by a draft product information document approved by the Secretary of the Department of Health and Ageing. The Restricted Medicine Specification 2011 is a legislative instrument that identifies the medicines or classes of medicines that are subject to these requirements, ensuring that applicants for registration of these restricted medicines must provide the necessary product information document. The specified medicines include those listed in Part 1 of Schedule 10 of the Therapeutic Goods Regulations 1990, excluding certain items, and those containing substances listed in Schedule 3 of the current Poisons Standard. This instrument applies to all entities seeking to register restricted medicines in Australia and aligns with the Therapeutic Goods Administration's existing administrative processes. It does not involve public consultation but reflects the administrative arrangements that have been in place for the approval of product information documents for prescription and other medicines.
Key Provisions
The Therapeutic Goods Act 1989 (TG Act) provides a framework for the regulation of therapeutic goods in Australia, focusing on ensuring their quality, safety, efficacy, and timely availability. The Therapeutic Goods Administration (TGA) administers this Act and associated regulations. In particular, sections 3(2A) and 3(2B) of the TG Act empower the Minister for Health and Ageing to specify certain medicines and classes of medicines as 'restricted'. A restricted medicine, as per subsection 3(1), is defined as a medicine listed in an instrument under subsection 3(2A) or a medicine belonging to a class listed in an instrument under subsection 3(2B). The purpose of the Restricted Medicine Specification 2011 is to specify these medicines and classes for the purposes of the definition of restricted medicine. This legislative instrument, which commences on the day after its registration in the Federal Register of Legislative Instruments, lists specific medicines and classes of medicines that are considered restricted (Schedule 1).
These obligations and requirements primarily concern the registration process for restricted medicines. Under section 23(2)(b) of the TG Act, any application for the registration of a restricted medicine must include a draft product information document in the form approved by the Secretary of the Department of Health and Ageing under section 7D. An application lacking this document is deemed ineffective and will not be considered. This product information document is a critical component of the evaluation process for determining whether the medicine should be approved for registration in the Australian Register of Therapeutic Goods. If the Secretary or their delegate decides to register the medicine, the applicant must be notified in writing of the approved product information, as per subparagraph 25(4)(d)(ia).
The instrument specifies that the medicines or classes of medicines included in Schedule 1 are those listed in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990, excluding items 1(b) and 14, and those containing substances listed in Schedule 3 of the current Poisons Standard. Part 1 of Schedule 10 includes high-risk substances mentioned in Schedules 4 (prescription only medicines), 8 (controlled drugs), or 9 (prohibited substances) of the Poisons Standard, vaccines, allergens, and immunoglobulins. Schedule 3 substances are those that can be supplied without a prescription but only by a pharmacist. The exclusion of item 1(b) and item 14 is justified because these refer to substances and therapeutic goods that are not applicable at the time of registration application.
Regarding penalties and consequences, the TG Act does not specify penalties for non-compliance with the requirements of the Restricted Medicine Specification 2011 directly. However, non-compliance with the TG Act generally could result in civil or criminal penalties, including fines and imprisonment. The exact penalties would depend on the specific breach and the provisions of the TG Act and related regulations. The administrative arrangements and requirements for product information documents reflect the TGA’s current practices, and the legislative instrument is designed to have minimal regulatory impact. While the making of this instrument did not involve public consultation, related amendments to the TG Act involved consultation with industry associations such as the Generic Medicines Industry Association (GMiA) and Medicines Australia.