Therapeutic Goods Order No. 87 General requirements for the labelling of biologicals (08/07/2011)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L01493 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject: THERAPEUTIC GOODS ORDER NO. 87 – GENERAL REQUIREMENTS FOR THE LABELLING OF BIOLOGICALS

 

Section 10, Therapeutic Goods Act 1989

 

OUTLINE

Therapeutic Goods Order No. 87 General requirements for the labelling of biologicals (TGO 87) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act).

 

TGO 87 determines that the matters specified in the instrument constitute the standards applying to biologicals in relation to labelling.

 

TGO 87 commences on 31 May 2012. This will allow a transition period for manufacturers to achieve compliance with the standards.

 

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans.  The Therapeutic Goods Administration (TGA) is responsible for administering the Act.

 

Section 10 of the Act authorises the Minister, or the Minister's delegate, to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (TGC), a committee established under the Therapeutic Goods Regulations 1990 (the Regulations) to advise the Minister on matters relating to standards.

 

Unless consent is granted by the Secretary under section 14 and 14A of the Act, therapeutic goods imported into Australia, supplied in Australia or exported from Australia must comply with any applicable standard.

 

A number of new provisions have been added to the Therapeutic Goods Act 1989 (the Act) and the Regulations to establish and implement a new regulatory framework for biologicals.  The new regulatory scheme for biologicals commenced on 31 May 2011.

 

Biologicals are defined in subsection 32A(1) of the Act as either things that comprise, contain or are derived of, human cells or tissues, or things specified by the Secretary in a legislative instrument under subsection 32A(2) of the Act as being biologicals.  Prior to the commencement of the new regulatory framework for biologicals, manufacturers of human tissues and cellular therapy products were required to hold a manufacturing licence, but such products were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (the Register).

 

Under the new regulatory framework, biologicals are required to be included in the Register.  For biologicals that are classified under the Regulations as being class 2, 3 or 4 biologicals (the Regulations specify and define 4 classes of biologicals), compliance with applicable standards must be demonstrated as part of the evaluation process in relation to suitability for inclusion in the Register.  Applicants for inclusion of class 1 biologicals in the Register must certify that the biological conforms to every standard (if any) applicable to it.

 

TGO 87 is a new standard made under section 10 of the Act, and applies to all biologicals, including for example human ocular tissue (e.g. corneas) and musculoskeletal tissue (e.g. bone) collected from living or deceased human donors and released for supply.  The requirements of the labelling Order recognise the unique circumstances in which biologicals, as distinct from other therapeutic goods, are collected, transported, processed, supplied and used including, for example, that biologicals are typically used in a clinical setting and not supplied directly to public consumers.

TGO 87 specifies the minimum labeling requirements that are considered necessary in relation to the safety and traceability of biologicals, including requirements regarding the information to be included on the label of a biological at the time of both collection and release of a biological.

In some instances, biologicals may be collected or supplied in several layers of packaging, such as in the case of femoral head (bone) donations, and the labeling of a layer may compromise the sterility of the biological.  In addressing such circumstances, TGO 87 requires that the non-sterile layer must be labelled.  TGO 87 also permits biological products with small labels that can not fit all the required information to set out a minimum amount of specified kinds of information on the label, with all other required information able to be provided with the product as accompanying documentation.

 

The requirements of TGO 87 do not apply to a transparent covering that wraps a container or primary pack containing a biological where a compliant label is clearly visible through that transparent covering.

 

CONSULTATION

A draft of TGO 87 was made available by the TGA for public consultation in December 2009.  A substantially revised version, which took into account feedback received regarding the first draft, was published by the TGA in December 2010 for a second round of public consultation.

 

In addition, TGO 87 has been considered and endorsed by the Therapeutic Goods Committee (the TGC) subcommittee on biologicals, and has been adopted by the TGC.

 

REGULATION IMPACT STATEMENT

The Office of Best Practice Regulation has agreed that no Regulation Impact Statement is necessary for TGO 87 (ORR ID number 12194).

 

It is important to note that the ‘Regulatory Impact Statement for the Regulation of Human Cellular and Tissue Therapy Products (biologicals)’ (ORR ID 5066 February 2009) included the requirement for human tissue products, including labelling requirements, to comply with standards.  In addition, the proposed new standards relating to biologicals (including labelling standards) have been discussed with the Australian tissue banking sector and the sector has indicated that the requirements of TGO 87 are not likely to have any significant additional direct or indirect impact on the tissue sector.

 

Overview

The Therapeutic Goods Order No. 87, or TGO 87, was introduced in 2012 under the Therapeutic Goods Act 1989 to establish the general requirements for the labelling of biologicals in Australia. This Order was made by the delegate of the Minister for Health and Ageing under section 10 of the Act, which empowers the Minister or their delegate to determine standards for therapeutic goods, including biologicals, after consulting with the Therapeutic Goods Committee. The objective of TGO 87 is to ensure the safety and traceability of biologicals, which include human cells, tissues, and other specified biological materials. By setting minimum labelling requirements, TGO 87 aims to maintain high standards for the collection, transportation, processing, supply, and use of biologicals, which are typically intended for clinical use rather than direct consumer supply. The Order came into effect on 31 May 2012 to provide a transition period for manufacturers to achieve compliance with the new standards. Public consultation was undertaken in drafting TGO 87, with revisions made based on feedback, and the Order was subsequently endorsed by the Therapeutic Goods Committee.

Scope and Application

Therapeutic Goods Order No. 87 General requirements for the labelling of biologicals (TGO 87) is an Order made under the Therapeutic Goods Act 1989 (the Act) and applies to all biologicals, including those derived from human cells or tissues such as ocular and musculoskeletal tissues. The Act provides for a national system of controls relating to the quality, safety, efficacy, and timely availability of therapeutic goods used in humans, with the Therapeutic Goods Administration (TGA) responsible for administering the Act. Section 10 of the Act allows the Minister or the Minister's delegate to determine standards for therapeutic goods, including labelling, after consultation with the Therapeutic Goods Committee (TGC). Unless consent is granted by the Secretary under section 14 and 14A of the Act, therapeutic goods imported into Australia, supplied in Australia, or exported from Australia must comply with applicable standards. TGO 87 specifies minimum labelling requirements that recognise the unique circumstances in which biologicals are collected, transported, processed, supplied, and used, aiming to ensure safety and traceability, and applies across all states and territories of Australia. The requirements do not apply to a transparent covering that wraps a container or primary pack containing a biological where a compliant label is clearly visible through that transparent covering. The labelling standards in TGO 87 were developed through public consultation and endorsement by the TGC subcommittee on biologicals.

Key Provisions

Therapeutic Goods Order No. 87 (TGO 87) sets forth the labelling standards for biologicals, as established under section 10 of the Therapeutic Goods Act 1989. It specifies the minimum labelling requirements necessary to ensure the safety and traceability of biologicals, including the information that must be present on the label at both the collection and release stages (section 1). The labelling requirements recognise the unique nature of biologicals, which are often used in clinical settings and not directly supplied to consumers. For instance, TGO 87 permits biological products with small labels to include a minimum amount of specified information directly on the label, with the remaining required information provided in accompanying documentation (section 2). However, it mandates that any non-sterile layer of packaging must be labelled (section 3). Importantly, TGO 87 does not apply to transparent coverings that allow a compliant label to be clearly visible (section 4). The parties or entities governed by TGO 87, particularly manufacturers and suppliers of biologicals, must ensure compliance with the specified labelling standards. This includes providing the required information on the label or in accompanying documentation, and ensuring that non-sterile layers of packaging are appropriately labelled (sections 1-4). Manufacturers must also demonstrate compliance with applicable standards as part of the evaluation process for inclusion in the Australian Register of Therapeutic Goods, particularly for biologicals classified as class 2, 3, or 4 (subsection 32A(1) and (2) of the Act). The Therapeutic Goods Administration (TGA) oversees the enforcement of these standards. Failure to comply with the labelling requirements stipulated in TGO 87 may result in significant consequences. While the Explanatory Statement does not explicitly outline specific offences, penalties, or consequences for non-compliance, it is implied that non-compliance with the standards could lead to regulatory action by the TGA. Such action may include refusal to register biologicals in the Australian Register of Therapeutic Goods, which is a critical requirement for the legal supply of therapeutic goods in Australia. Additionally, non-compliance could potentially lead to legal proceedings under the Therapeutic Goods Act 1989, resulting in civil or criminal penalties. The specific penalties for non-compliance are not detailed in the Explanatory Statement, but they could include fines and imprisonment, depending on the nature and severity of the breach.

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