Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021

The order defines and operationalises several key concepts. HCT materials means human cells, human tissues, or human stool collected for use in the manufacture of a biological, whether as a constituent, container, or derivation source (section 4). This is broader than the traditional focus on cells and tissues; the inclusion of human stool reflects emerging therapeutic applications such as faecal microbiota transplantation. Biological takes its meaning from subsection 3(1) of the Act, and the order distinguishes between four classes of biological by reference to the Regulations: Class 1, Class 2, Class 3 and Class 4 biologicals each have different implications for what label information is required, especially in Part 2 of Schedule 2 (items 6, 7, 8, 29, 30, 31). The classes reflect increasing levels of regulatory scrutiny, with Class 1 being the lowest risk and Class 4 the highest. The order distinguishes three use categories for biologicals derived from HCT materials: autologous use (administration to the donor), allogeneic use (administration to someone other than the donor), and directed allogeneic use (a subset of allogeneic use where a medical or dental practitioner collects the HCT materials for a designated patient with a pre-existing condition, and both practitioners are registered in a State or internal Territory). This distinction drives whether the label must include the words autologous use only and the recipient identifier (Schedule 2, Part 1, item 4) or the designated patient identifier (Schedule 2, Part 1, item 5). Sponsor is defined in the Act and the order requires the sponsor's name on the label (Schedule 2, Part 1, item 6) and the sponsor's Australian principal place of business address, phone number and email address on or with the container or primary pack (Schedule 2, Part 2, item 4). The order introduces a distinction between Part 1 information and Part 2 information for biologicals. Part 1 information must be physically on or attached to both the container and the primary pack (or, for sterile containers, on the first external non-sterile layer of packaging and the primary pack). Part 2 information may be supplied separately, including via an electronic reference document accessible through a link or QR code on the container or primary pack (section 10(1)(b)(ii)). This electronic option is a notable concession to practical realities, as many biologicals have lengthy product information that cannot fit on a small vial label. The order also carries forward the concept of expiry date as defined in the Regulations. The batch number is required when one exists (Schedule 2, Part 1, item 2), not in all cases, which is sensible for single-patient biologicals where batch concepts may not apply.

The order directly affects several categories of persons and organisations. Sponsors of biologicals supplied in Australia bear the primary compliance obligation. A sponsor is the person or company responsible for the biological in the Australian market, often the manufacturer, importer, or licence holder. Sponsors must ensure that every unit of biological supplied in Australia meets the labelling requirements of Schedule 2, and that any HCT materials used in manufacture comply with Schedule 1 before they are accepted or processed. Manufacturers of biologicals must also ensure traceability labelling at each step of manufacture (section 8(3)), which imposes logistical and documentary burdens, particularly for facilities handling multiple donors or multiple HCT material types. Collection facilities for HCT materials must ensure that containers leaving the facility bear at minimum a unique donor identifier (item 1 of Schedule 1), plus the type of HCT materials, the date and time of collection, the facility name and address, and the name of the designated person collecting the materials (items 2 through 5). If space is insufficient, items 2 to 5 may be supplied with the container rather than affixed (section 9(2)). This flexibility reduces compliance cost for small collection facilities such as hospital blood banks or tissue collection suites. Medical and dental practitioners who collect HCT materials for directed allogeneic use are implicated because their registration status in a State or internal Territory is part of the definition of directed allogeneic use (section 4). If the practitioner is not appropriately registered, the biological may not qualify for that category and the labelling requirements for allogeneic (non-directed) use may apply. Patients who are recipients of autologous or directed allogeneic biologicals are affected indirectly, as their name or identifier must appear on the label, raising privacy and data security considerations for the labelling and packaging process. Exporters of biologicals are only minimally affected: they need only include a donor identifier on exports of HCT materials (section 9(3)) or biologicals (section 10(2)). This carve-out reduces compliance costs for Australian exporters competing in overseas markets where different labelling rules may apply. The order also affects healthcare professionals who handle or administer biologicals. They rely on the label for critical information such as storage conditions, expiry date, instructions for use, precautions, warnings, contraindications, interactions, adverse effect warnings, and reporting instructions (Schedule 2, Part 2, items 9, 10, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27). If any of this information is only available via a QR code, the healthcare professional must have the means and time to access it, which may be impractical in a busy clinical setting. The electronic option may shift costs from sponsors to clinicians.

The order imposes several specific duties on sponsors and manufacturers. The primary duty is to ensure that every biological supplied in Australia bears the information set out in Schedule 2 in the manner prescribed by section 10. For Part 1 information, the duty is absolute: it must be on or attached to the container and the primary pack (or the first external non-sterile layer for sterile containers). There is no option to supply Part 1 information separately or electronically. For Part 2 information, the duty may be satisfied by attaching it to the container or primary pack, by supplying it with the product (for example, as a package insert), or by making it available through an electronic reference document accessible via a link or QR code on the container or primary pack (section 10(1)(b)(ii)). This electronic option is a right, not a duty: sponsors may choose to use it, but they are not required to. The duty to label HCT materials under section 9 is slightly different. The information in Schedule 1 must be on or attached to the container (or first external non-sterile layer for sterile containers), but if there is insufficient space, only item 1 (the donor identifier) must be on the container, and items 2 to 5 may be supplied with the container. This is a practical concession for small containers such as cryovials or blood bags where affixing five discrete pieces of information may be physically impossible. The duty of traceability is imposed by section 8(3): the container of HCT materials must be labelled to ensure traceability to the donor at each step of manufacture. This duty applies throughout the manufacturing chain, not just at the point of supply. It means that intermediate containers holding partially processed materials must also bear donor identification. This has implications for manufacturing workflow design and inventory management systems. The duty to use English, legible characters of at least 1.5 millimetres, metric units, and securely attached labels that maintain integrity at storage conditions (section 8(1) and (2)) applies to all labels under the order. These are minimum standards; nothing prevents a sponsor from using larger text, additional languages, or redundant labelling formats. The order also confers a limited right to use transparent coverings (blister packs, shrink wrap, outer cartons) without needing to duplicate the label information on those coverings, provided the underlying label information remains clearly visible and not obscured (section 8(4)). During the transition period (30 September 2021 to 30 September 2022), sponsors had the right to comply with either TGO 107 or the former TGO 87 (section 7(2)). This transitional right has now expired, so all labels must comply with TGO 107 as at October 2022.

The order itself does not create or specify penalties. It is a legislative instrument made under section 10 of the Therapeutic Goods Act 1989, which empowers the Minister or delegate to establish standards for therapeutic goods. The enforcement framework is provided by the Act. Supplying a biological that does not comply with an applicable standard is likely to constitute a breach of the Act. The Act contains civil penalty provisions for non-compliance with standards, as well as criminal offences for more serious conduct such as supplying goods that are not entered in the Australian Register of Therapeutic Goods (ARTG) or that do not meet required standards. The maximum civil penalties under the Act are substantial, with the current penalty unit rate applying to each contravention. For a body corporate, civil penalties can reach into the millions of dollars. The Therapeutic Goods Administration (TGA) can also take other enforcement actions: it may issue infringement notices (on-the-spot fines), accept enforceable undertakings, or seek injunctions from the Federal Court to stop supply or require recall of non-compliant products. A failure to comply with the standard could also lead to suspension or cancellation of the biological's entry in the ARTG, effectively removing the product from the Australian market until compliance is achieved. The traceability requirement in section 8(3) is particularly significant for enforcement. If a sponsor cannot demonstrate that containers were labelled for traceability at each step of manufacture, the TGA may treat the entire batch as non-compliant. This could lead to recall orders and potential liability for costs. The order also creates exposure through the requirement to include specific warnings and precautions (Schedule 2, Part 2, items 19 through 26). If a product causes harm and the label did not include a required warning, the sponsor may face not only regulatory action but also civil liability under common law for failure to warn. While the order is not itself a source of private rights of action, compliance with it would be relevant evidence in any negligence or consumer protection proceeding. Enforcement priorities are likely to focus on the more serious risks: mislabelling of autologous versus allogeneic product, failure to include donor identifiers, and absence of critical safety warnings. Minor formatting issues such as letter height slightly below 1.5 millimetres may attract a warning letter rather than a penalty proceeding, but the order gives no formal safe harbour for de minimis non-compliance.

The order sits within a broader legislative and regulatory framework for therapeutic goods in Australia. It is made under section 10 of the Therapeutic Goods Act 1989, and its definitions draw on that Act, particularly the terms biological, container, label, manufacture, primary pack, Register, and standard as defined in subsection 3(1) of the Act. The order also relies on the Therapeutic Goods Regulations 1990 for definitions of Class 1 biological, Class 2 biological, Class 3 biological, Class 4 biological, and expiry date (section 4). Changes to those regulations would flow through to the operation of this order without amendment. The order expressly excludes biologicals mentioned in item 13 of Schedule 5A to the Regulations, subject to compliance with the condition in that item (section 6(1)). This exclusion covers certain biologicals that are exempt from some or all of the standard labelling requirements, but the details depend on the Regulations. Practitioners must check the current version of Schedule 5A to determine whether a particular biological falls within the exclusion. The order partially replaces the former TGO 87, which was repealed by the Therapeutic Goods (Standards for Biologicals) Repeal Instrument 2021. The transition period (section 7) allowed concurrent compliance with either standard for one year, creating a temporary overlap. After 30 September 2022, only TGO 107 applies. For biologicals that are also therapeutic devices, cosmetics, or medicines, separate standards under the Act may also apply. The order does not purport to displace those standards; a biological that is also a device must comply with both the biological labelling standard and the applicable device standard. Similarly, state and territory laws regarding the collection of human tissues and cells, such as the Human Tissue Act in each jurisdiction, continue to apply to the collection of HCT materials. The order does not harmonise or override those laws; it merely imposes additional labelling requirements on the containers leaving collection facilities. Privacy laws, including the Privacy Act 1988 (Cth) and state health records legislation, interact with the labelling requirements for autologous and directed allogeneic use. Placing a patient name or identifier on a label creates a disclosure of health information. Sponsors must ensure that this disclosure is authorised by the patient or otherwise permitted under applicable privacy law. The order does not address this interaction; it simply mandates the label content. For biologicals exported from Australia, the order imposes only minimal requirements (donor identifier), but the destination country's laws may impose more extensive requirements. Compliance with Australian law does not guarantee compliance with foreign law, and exporters should seek independent advice on the labelling rules of the importing country.

The order was made on 24 September 2021 by Adjunct Professor John Skerritt as delegate of the Minister for Health and Aged Care. It commenced on 30 September 2021. The instrument was made as a replacement for the former TGO 87, which was repealed by the Therapeutic Goods (Standards for Biologicals) Repeal Instrument 2021 on the same date. The order has not been amended since its commencement, according to the text provided. The commencement table in section 2 confirms that the whole instrument commenced on 30 September 2021 with no staged commencement. The note to the table advises that any information in column 3 of the table is not part of the instrument and may be edited in published versions. The transition period under section 7 operated from 30 September 2021 to 30 September 2022, after which the former TGO 87 ceased to be an alternative compliance pathway. No subsequent amending instruments are referenced in the source text. Users should check the Federal Register of Legislation for any amendments made after the date of this version. The absence of amendments to date suggests the instrument has been operating without major issues, but that may also reflect the relatively small size of the biologicals sector compared to other therapeutic goods categories.

The source text does not refer to any litigation concerning this order. No cases are cited in the instrument, and no decisions are mentioned in the definitions, notes, or schedules. Given that the order came into effect only in September 2021 and largely codifies existing practices under TGO 87, there has likely been insufficient time for litigated disputes to reach final determination. The technical and prescriptive nature of labelling standards also makes them less likely to generate litigation than substantive regulatory decisions such as ARTG refusal or cancellation. Any legal challenge would most likely arise from a TGA enforcement action, where the sponsor disputes whether the standard applies or whether the product complied. That case would be heard in the Federal Court of Australia or the Administrative Appeals Tribunal, depending on the nature of the decision. The definitional boundaries, such as whether a particular material falls within HCT materials (especially human stool) or whether a practitioner is registered in a State or internal Territory for directed allogeneic use, could be contested in litigation. However, no reported cases have yet interpreted these provisions. The absence of litigation history does not mean the instrument is immune from challenge; it only means none has occurred to date. Practitioners should monitor the TGA's compliance and enforcement activities for early indications of how the standard is being applied in practice.

Several provisions in this order contain traps for the unwary. The most significant is the traceability requirement in section 8(3): The container of a biological or HCT materials must be labelled to ensure traceability to the donor of the HCT materials at each step of manufacture. This is not limited to the final container. Every intermediate container in the manufacturing process must bear a donor identifier. A manufacturer that only labels the final product container and relies on internal batch records for intermediate steps may be non-compliant. The phrase at each step of manufacture imposes a real operational burden. The space exception for HCT materials in section 9(2) is another trap. If there is insufficient space on the container, only item 1 of Schedule 1 (donor identifier) must be on the container; items 2 to 5 (type, date/time, collection facility, collector name) may be supplied with the container. However, supplied with the container is not defined. If the container is separated from the accompanying documentation during transport or storage, those items are effectively lost. The order does not require the accompanying documentation to be physically attached or to remain with the container. This creates a risk that critical information about collection date, time, and source may be separated from the material. The electronic option for Part 2 information (section 10(1)(b)(ii)) is a double-edged sword. It allows a QR code or link to replace a physical package insert, but the electronic reference document must contain all the required Part 2 information. If the link is dead, the QR code is damaged, or the user lacks internet access, the information is unavailable. The order does not require offline backup or a physical alternative. For a healthcare professional in an operating theatre or clinic with poor connectivity, this could be a serious issue. The order does not impose any data format or accessibility standards for electronic documents. The export exemption is limited. Biologicals exported from Australia need only bear the donor identifier (item 1 of Schedule 1 or item 1 of Part 1 of Schedule 2). But if the exporter also supplies the same product in Australia, the full labelling standard applies to Australian-supplied units. Maintaining two separate label stocks for domestic and export product may increase costs and risk of mix-up. The interaction of the autologous use labelling requirement with privacy law is not addressed. Schedule 2, Part 1, item 4 requires the name or identifier of the intended recipient on the label for autologous use products. If the identifier is the patient's full name, this creates a privacy disclosure every time the product is handled or transported. A unique code may be preferable, but the order does not prescribe or suggest this. For directed allogeneic use, the definition requires the collecting practitioner and the treating practitioner to be registered in a State or internal Territory (section 4). This does not require them to be registered in the same state, only that each is registered somewhere in Australia. However, a practitioner whose registration is suspended or subject to conditions may not satisfy the definition, potentially reclassifying the product from directed allogeneic to general allogeneic and changing the label requirements. The transitional arrangements in section 7 expired on 30 September 2022. Any sponsor still using TGO 87-compliant labels after that date is non-compliant. The order does not provide for any grace period for existing stocks. The letter-height requirement of 1.5 millimetres (section 8(1)(c)) is absolute. There is no exception for very small containers such as microvials or syringe labels. If a container cannot physically accommodate 1.5 mm characters for all required Part 1 information, the sponsor must either use a larger container, attach a label to the primary pack instead, or for HCT materials use the space exception. Biologicals do not have a space exception. The order does not mandate that QR codes or links be accessible by persons with disability, nor does it require audio or large-print alternatives. This may raise accessibility concerns under the Disability Discrimination Act 1992 (Cth) if patients or clinicians cannot access electronic information.

Compliance with TGO 107 requires a systematic review of current labelling practices and documentation. The first step is to classify the product correctly. Determine whether the product is a biological as defined in the Act, whether it contains or is derived from HCT materials, and whether it is Class 1, 2, 3 or 4 under the Regulations. Also determine the use category: autologous, allogeneic (non-directed), or directed allogeneic. These classifications determine which items in the Schedules apply. Next, audit the container and primary pack. For biologicals, ensure that all Part 1 information (as determined by the circumstances in column 3 of the table in Part 1 of Schedule 2) is physically on or attached to both the container and the primary pack. If the product is in a sterile container, the information may be on the first external non-sterile layer instead of the container itself, but must still be on the primary pack. Check that the donor identifier (item 1) is present in all cases. For autologous use, ensure the words autologous use only and the recipient name or identifier appear on both container and primary pack (Part 1, item 4) and also on or with the product (Part 2, item 1). For directed allogeneic use, the designated patient identifier must appear on the container and primary pack (Part 1, item 5) and also on or with the product (Part 2, item 2). The sponsor name must appear on the container and primary pack (Part 1, item 6) and the sponsor's Australian address, phone and email must be on or with the product (Part 2, item 4). For Part 2 information, decide whether to affix it to the container or primary pack, supply it as a physical insert, or make it available via electronic reference with a QR code or link on the package. If using the electronic option, test that the link works, the document is accessible, and the QR code can be scanned reliably. Ensure that the electronic document contains all required Part 2 information items that apply to the product. Do not rely on the electronic option for Part 1 information; it is not permitted. For HCT materials, ensure each container (or first external non-sterile layer) bears the donor identifier. If space permits, affix all five items of Schedule 1. If space is insufficient, affix item 1 and supply items 2 to 5 with the container, but consider how to ensure the accompanying documentation stays with the container throughout transport and storage. Verify traceability at each step of manufacture. Implement a system that links every intermediate container to the donor identifier, whether by barcode, RFID, or manual labelling. Document this system for inspection purposes. Conduct a legibility check: confirm all text is in English, in characters at least 1.5 mm high, clearly visible, not obscured, and in metric units. Test that labels remain securely attached and legible after storage at the product's specified conditions (temperature, humidity, handling). For sterile products, ensure the labelling method does not compromise sterility. If using transparent coverings, verify that the underlying label information remains clearly visible and not obscured. Review the product's ARTG entry and any applicable exclusion under item 13 of Schedule 5A to the Regulations before assuming an exemption. If the product is exported, prepare separate labels at least meeting the donor identifier requirement, but check the destination country's rules as they may be more onerous. Finally, create a compliance checklist cross-referencing each item in Schedules 1 and 2 against the physical label and any accompanying documentation or electronic reference. Retain this checklist as part of the quality management system. Regularly monitor the Federal Register of Legislation for amendments to TGO 107 or related regulations that may affect classification or labelling requirements.