Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health and Aged Care (“the Department”).

Section 61 of the Act provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies or authorities. Subsection 61(1) of the Act provides that therapeutic goods information means, for the purposes of the section, information relating to therapeutic goods, that that is held by the Department and relates to the performance of the Department’s functions.

Subsection 61(5C) of the Act provides that the Secretary may release to the public therapeutic goods information of a kind specified under subsection 61(5D). Subsection 61(5D) provides that the Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection 61(5C).

The Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025 (“the Instrument”) is a legislative instrument made under subsection 61(5D) of the Act. It specifies kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act.

Broadly, the Instrument provides for the release of specified kinds of therapeutic goods information from the TGA’s new Database of Recalls, Product Alerts and Product Corrections (“the DRAC”). Such information relates to market actions undertaken (or to be undertaken) by responsible entities to address a problem or concern relating to the quality, safety, efficacy or performance, presentation or use of therapeutic goods that are supplied in Australia.

On 5 March 2025, the DRAC will replace the System for Australian Recall Actions (“the SARA”) as the TGA’s public database for information relating to therapeutic goods that are the subject of market actions in Australia. The TGA’s maintenance of the DRAC, and the public release of relevant information from this database, ensures that key external stakeholders, such as therapeutic goods sponsors and manufacturers, patients, health practitioners, and other regulatory agencies, have timely access to information about market actions relating to therapeutic goods in Australia.

The Instrument also repeals the Therapeutic Goods (System for Australian Recall Actions) (Information) Specification 2023 (“the former Specification”), with effect from 5 April 2025. The delayed commencement of this repeal provides for a transition period of one month following the anticipated implementation of the DRAC, during which the Secretary may, if necessary or desirable, continue to release to the public therapeutic goods information of a kind specified in the former Specification.

Background

Where a problem or concern arises in relation to the quality, safety, efficacy or performance, presentation or use of therapeutic goods that are supplied in Australia, the TGA expects that appropriate market action will be taken to address the problem or concern in a timely manner.

Market action is undertaken by the ‘responsible entity’, which is either the person in relation to whom the therapeutic goods are included in the Australian Register of Therapeutic Goods (“the Register”), or, if the goods are not in the Register, the supplier of the goods in Australia. However, the TGA is actively involved throughout the market action process, including in the identification of problems or concerns with therapeutic goods, the monitoring of therapeutic goods through product vigilance activities, and working with responsible entities to determine the most appropriate market action strategy in the relevant circumstances.

Market action generally involves the responsible entity doing one or more of the following in relation to the therapeutic goods:

issuing a product alert—to notify the public, or particular persons or classes of persons such as patients or health practitioners, of the problem or concern and provide advice for risk or harm mitigation;
undertaking product correction—including, for example, by:

- repairing, modifying or relabelling the goods;

- updating software, instructions for use, or patient information leaflets; or

- making corrections to product details such as expiry dates or batch numbers;

recalling the goods—for example, by removing the goods from supply chains and ceasing further distribution, recovering goods that have been supplied to wholesalers, retailers or consumers, or requesting that such persons return the goods to the responsible entity;
destroying, or arranging for the destruction of, the goods.

Market action is usually undertaken voluntarily by responsible entities, typically in accordance with the TGA’s current guidelines in the Uniform Recall Procedure for Therapeutic Goods (“URPTG”), which is publicly available on the TGA’s website. Broadly, this involves the responsible entity notifying the TGA of the problem or concern in relation to the therapeutic goods, the responsible entity’s assessment of the risks associated with that problem or concern, and the responsible entity’s proposed market action and communication strategy. The TGA then undertakes an independent and objective assessment of the problem or concern, the associated risks and the responsible entity’s proposed market action and communication strategy.

However, in some instances, the Secretary may require responsible entities to undertake certain market actions, including recalls, in relation to therapeutic goods (sections 30EA, 32HA and 41KA of the Act refer). The Secretary may decide to exercise these powers in circumstances where, for example, the TGA and responsible entity cannot agree on a market action strategy that would best protect the health and safety of patients and other users of the goods in Australia. A person may commit an offence or be liable to a civil penalty under the Act if they fail to comply with such a requirement imposed by the Secretary.

Database of Recalls, Product Alerts and Product Corrections (DRAC)

The TGA currently publishes information relating to market actions in the SARA. The SARA contains information about recall action for therapeutic good supplied in Australia, and was developed following feedback received from external stakeholders that the TGA should increase its transparency by releasing additional information about therapeutic goods.

On 5 March 2025, the DRAC will replace the SARA as the TGA’s database for information about market actions relating to therapeutic goods supplied in Australia. The DRAC, which will be maintained by the TGA and publicly available on the TGA’s website, will contain information such as details of the goods subject to the market action, the responsible entity, the problem or concern relating to the goods, and how patients and other users of the goods can mitigate or manage any risks associated with use of the goods. This information is all currently published in the SARA.

The public release of information about market actions relating to therapeutic goods supplied in Australia, provides benefits to a range of key stakeholders. This includes persons affected or most likely to be affected by the market action, such as patients, health practitioners and other users of the goods, who require timely access to information about the problem or concern relating to the goods, the associated risks, and the steps that can be taken to manage or mitigate those risks. Other key stakeholders include Commonwealth, state and territory government agencies, academics, students, legal professionals and members of the public who have an interest in the conduct or outcome of the market action.

Purpose

The Instrument specifies the kinds of therapeutic goods information in the DRAC that the Secretary may release under subsection 61(5C) of the Act. The Instrument supports the release of information in the DRAC about market action taken, or being taken, in relation to therapeutic goods supplied in Australia.

Schedule 1 to the Instrument sets out in detail the kinds of therapeutic goods information that the Secretary may release to the public in the form of the DRAC. This includes, among other specified kinds of information:

details of the goods subject to the market action, and the responsible entity for those goods;
details of the problem or concern with the quality, safety, efficacy or performance, presentation or use of the goods, and the relevant market action taken, being taken or to be taken;
the classification of the market action, as determined by the TGA based on the seriousness of the harm that may be caused by the goods, and the likelihood of that harm occurring;
the level of market action to be implemented by the responsible entity, or required by the Secretary under section 30EA, 32HA or 41KA of the Act, based on the persons or bodies, or classes of persons or bodies that are, or are likely to be, impacted by the market action; and
any instructions or advice to be provided by the responsible entity to health practitioners, patients or other persons affected, or likely to be affected, by the market action, as part of that action.

The kinds of therapeutic goods information specified in the Instrument are, in most instances, the same as those specified in the former Specification. However, the terminology used to describe certain of the specified kinds of information has been updated, principally to reflect the simplified terminology used in the DRAC. For example, the expression ‘market action’, rather than ‘recall action’, is used in the Instrument to cover the range of measures that responsible entities can, or are required to, implement to address a problem or concern relating to their therapeutic goods.

The Instrument also repeals the former Specification, effective from 5 April 2025, as the latter instrument will no longer be required to support the publication of the SARA after that date. The delayed commencement is to accommodate any potential delay in the publication of the DRAC, during which the SARA will continue to be available.

Consultation

In January 2023, the TGA consulted with the public and sought feedback on proposed improvements to the URPTG, including changes to simplify recall terminology. The TGA received 71 separate responses, including responses from sponsors and manufacturers, peak industry bodies, healthcare organisations and medical guilds, retail organisations, state or territory government officials, and consumer or patient support groups.

Most responses demonstrated support for the proposed changes to the URPTG. As part of their feedback, respondents noted a preference for the proposed simplified recall terminology and new market action descriptions, and a preference for the reduction in the number of market action categories. Some mixed feedback was received in relation to other aspects of the recall process that are unrelated to the kind of information to be released in the DRAC (such as timeframes).

No consultation was undertaken specifically in relation to the development of the Instrument as the changes to the instrument are mainly intended to reflect the changes to the URPTG. The Instrument supports the implementation of the Procedure for Recalls, Product Alerts and Product Corrections, which will replace the URPTG on 5 March 2025 and be publicly available on the TGA’s website.

Other details

An Impact Analysis (“IA”) was not required in relation to the development of the Instrument, as the matter of specifying kinds of therapeutic goods information under section 61 of the Act is the subject of a standing exemption from the requirement to prepare an IA (OBPR ID15070).

Details of the Instrument are set out in Attachment A.

The Instrument is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

The Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on the day after it is registered on the Federal Register of Legislation, except for Schedule 2, which commences on 5 April 2025.

Attachment A

Details of the Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025 (“the Instrument”).

Section 2 – Commencement

This section provides for the commencement of the Instrument on the day after registration on the Federal Register of Legislation, except for Schedule 2, which commences on 5 April 2025.

Section 3 – Authority

This section provides that the legislative authority for making the Instrument is subsection 61(5D) of the Therapeutic Goods Act 1989 (“the Act”).

Section 4 – Definitions

This section provides the definition of key terms used in the Instrument, including ‘hazard classification’, ‘instructions for users’, ‘market action’ and ‘responsible entity’.

This section also notes that some expressions used in the Instrument, including ‘biological number’, ‘device number’, ‘health practitioner’, ‘included in the Register’, ‘indications’, ‘listed goods’, ‘listing number’, ‘Register’, ‘registered goods’, ‘registration number’, ‘Secretary’ and ‘therapeutic goods’ have the same meaning as in the Act.

Section 5 – Therapeutic goods information

This section provides that the kinds of therapeutic goods information set out in the table in Schedule 1 are specified for the purpose of subsection 61(5C) of the Act. The effect of this section is to enable the Secretary to release to the public therapeutic goods information of the kind set out in Schedule 1 to the Instrument.

Section 6 – Repeals

This section provides that each instrument that is specified in Schedule 2 to the Instrument is repealed as set out in the applicable items in that Schedule.

Schedule 1─Specified kinds of therapeutic goods information

This Schedule specifies, for the purposes of section 5 of the Instrument, kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act.

The Schedule specifies information about market actions in relation to therapeutic goods that is held by the Therapeutic Goods Administration (“the TGA”) in its Database of Recalls, Product Alerts and Product Corrections (“the DRAC”), including the following:

details of the goods, including trade names, indications, active ingredients (where relevant) and other information about the goods such as:

- the batch, lot or serial number of the goods;

- the date the goods were manufactured or supplied; and

- the expiry date of the goods;

the type of goods (in other words, whether the goods are medicines, biologicals or medical devices);
if the goods are in the Australian Register of Therapeutic Goods (“the Register”)—the registration number, listing number, biological number or device number of the goods;
if the goods are medical devices—one or both of the following:

- the unique product identifier;

- any unique identifier that would enable identification of the device, including identification of the model or other information relating to the device;

details of the market action taken, being taken or to be taken in relation to the goods (see below);
details of the problem or concern relating to the goods, including, for example, how the problem or concern may affect the quality, safety, efficacy or performance, presentation or use of the goods, and details of the harm that may be caused to patients and other users of the goods;
the action commencement date, being the date the market action strategy to be implemented by the responsible entity was agreed to by the TGA;
the hazard classification and action level of the market action (see below);
the TGA action ID, being the unique combination of numbers, symbols and letters that the TGA assigns to the market action;
the responsible entity for the goods, being:

- if the goods are in the Register—the person in relation to whom the goods are registered, listed or included in the Register (typically the sponsor); or

- in all other cases—the supplier of the goods in Australia;

the instructions for users, being any instructions or advice given by the responsible entity to health practitioners and other persons affected, or likely to be affected, by the market action, as part of that action;
the contact information of the responsible entity.

Market action, hazard classification and action level

The expression ‘market action’, in relation to therapeutic goods supplied in Australia, means one or more of the following measures implemented (or to be implemented) by the responsible entity to address a problem or concern relating to the quality, safety, efficacy or performance, presentation or use of the goods:

recalling or destroying all or some of the goods;
notifying the public, or particular persons or classes of persons, of the problem or concern and of advice for risk or harm mitigation;
rectifying the problem with the goods, including by (but not limited to) repairing, modifying, adjusting or relabelling the goods.

Notably, the definition of ‘market action’ refers to not only problems, but also concerns relating to therapeutic goods. The reference to ‘concerns’ is intended to encompass situations such as where the relevant issue may be in relation to factors such as the way in which persons may be using, transporting or storing the goods.

The hazard classification is the classification of market action determined by the TGA based on the seriousness of harm that may be caused by the goods subject to the market action, and the likelihood of that harm occurring. There are three hazard classifications:

Class I – Critical safety-related, where the problem or concern presents a reasonable possibility of serious injury or death;
Class II – Urgent safety-related, where the problem or concern presents a reasonable possibility of temporary or minor injury, and the likelihood of serious injury or death is remote; and
Class III – Lowest risk, where there is no safety risk, or the problem is unlikely to result in injury, or the risk of a temporary or minor injury is remote.

The action level is the level of market action to be implemented by the responsible entity, based on the persons or bodies, or classes of persons or bodies, that are or are likely to be impacted by the market action. The action level in relation to a market action typically reflects the extent to which the goods subject to the market action have been supplied (e.g., whether the goods have only been supplied to wholesalers at the time the problem or concern is identified, or whether the goods have travelled through the supply chain and been purchased by end users). The action level may be adjusted based on the risk of the problem or other factors, such as to avoid a shortage, or where the benefit of removing the product from end users would not outweigh the risk of discontinuing treatment.

There are four action levels:

Wholesale level, where the goods have been supplied to wholesalers, state and territory purchasing authorities, and other distributors;
Hospital level, where, in addition to the wholesale level, the goods have been supplied to hospitals, hospital pharmacies, nursing homes, respite facilities, dental clinics, pathology laboratories, blood and human tissue banks or ambulance services;
Retail level, where, in addition to the wholesale and hospital levels, the goods have been supplied to health practitioners including retail pharmacists, other health professionals not working in the medical, dental, or nursing professions, and all other retail outlets such as supermarkets, health food stores and online stores; and
Consumer level, where, in addition to the wholesale, hospital and retail levels, the goods have been supplied to patients and other consumers.

Personal information

In limited circumstances, the therapeutic goods information specified in the Instrument may include personal information. Such information would possibly include:

the name and contact information of the responsible entity, where the responsible entity is an individual or the contact information refers to an individual; and
the trade name of the good, where this includes the name of an individual (noting that trade names infrequently contain the names, or parts of the names, of sponsors and manufacturers).

In most instances, the responsible entity is a company, meaning that the release of the name and contact information of the entity will not constitute personal information. However, if the responsible entity is an individual, or if the responsible entity elects to provide the name and contact information of an individual (e.g., an employee) as the primary point of contact, the release of the specified information may result in the release of personal information that is not otherwise publicly available. We note that contact details for the responsible entity are provided by the responsible entity, so the inclusion of personal information (e.g. an employee) would be because the responsible entity chose to provide that information.

In relation to trade names, this would only include personal information in very few cases as the sponsor or manufacturer of a good is, in most cases, a company and such names are only likely to involve a person’s name where a person has elected to name their company, or their products, in such a way as to include or comprise their name (this is very rare). When this is the case, and the goods are included in the Register, the name of the company, or goods, incorporating the person’s name would be publicly available as part of the publicly searchable elements of the Register on the TGA’s website. Further, in cases where the goods subject to the market action are not included in the Register, the sponsor or trade name may already be publicly available on the label of the goods.

The TGA, as part of the Australian Government Department of Health and Aged Care, is an APP entity for the purposes of the Privacy Act 1988 (“the Privacy Act”). Any use or disclosure of personal information in accordance with this Instrument would be consistent with the Privacy Act. The collection and use of the information specified in the Instrument, and its disclosure, is critical to ensuring the effective management and communication of market actions concerning therapeutic goods in Australia. It is therefore important that the TGA be able to share with the public the name of a responsible entity, and appropriate contact details, and the trade name of a particular good, even where such information may include personal information.

Schedule 2─Repeals

This Schedule, which commences on 5 April 2025, provides that the Therapeutic Goods Information (System for Australian Recall Actions) Specification 2023 is repealed. This instrument is no longer needed to support the SARA as the SARA will be replaced by the DRAC.

Attachment B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of legislative instrument

Section 61 of the Therapeutic Goods Act 1989 (“the Act”) provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies or authorities. Subsection 61(1) of the Act provides that therapeutic goods information means, for the purposes of the section, information relating to therapeutic goods, that that is held by the Department and relates to the performance of the Department’s functions.

Background

Market action generally involves the responsible entity doing one or more of the following in relation to the therapeutic goods:

issuing a product alert—to notify the public, or particular persons or classes of persons such as patients or health practitioners, of the problem or concern and provide advice for risk or harm mitigation;
undertaking product correction—including, for example, by:

- repairing, modifying or relabelling the goods;

- updating software, instructions for use, or patient information leaflets; or

- making corrections to product details such as expiry dates or batch numbers;

recalling the goods—for example, by removing the goods from supply chains and ceasing further distribution, recovering goods that have been supplied to wholesalers, retailers or consumers, or requesting that such persons return the goods to the responsible entity;
destroying, or arranging for the destruction of, the goods.

Database of Recalls, Product Alerts and Product Corrections (DRAC)

Purpose

details of the goods subject to the market action, and the responsible entity for those goods;
details of the problem or concern with the quality, safety, efficacy or performance, presentation or use of the goods, and the relevant market action taken, being taken or to be taken;
the classification of the market action, as determined by the TGA based on the seriousness of the harm that may be caused by the goods, and the likelihood of that harm occurring;
the level of market action implemented by the responsible entity, or required by the Secretary under section 30EA, 32HA or 41KA of the Act, based on the persons or bodies, or classes of persons or bodies that are, or are likely to be, impacted by the market action; and
any instructions or advice to be provided by the responsible entity to health practitioners, patients or other persons affected, or likely to be affected, by the market action, as part of that action.

Human rights implications

The instrument engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural rights (“the ICESCR”) and the right to protection against arbitrary and unlawful interferences with privacy in Article 17 of the International Covenant on Civil and Political Rights (“the ICCPR”).

Right to Health

Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health.

In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

The Instrument takes positive steps to promote the right to health by facilitating the public release of therapeutic goods information relating to market actions in Australia. The Instrument ensures that persons are able to access important information regarding goods subject to market action, including the name and a description of the goods, details of the market action taken, being taken or to be taken, the name of the person or entity responsible for the market action, and market action instructions (including advice for patients and health practitioners affected by the market action). This also ensures that the public have contact details for obtaining more information if needed.

Right to protection against arbitrary and unlawful interferences with privacy

Article 17 of the ICCPR provides for the right of every person not to be subjected to arbitrary or unlawful interference with privacy. The prohibition on interference with privacy prohibits unlawful or arbitrary interferences with a person’s privacy, family, home and correspondence. It also prohibits unlawful attacks on a person’s reputation. Limitations on the right to privacy must be according to law and not arbitrary, i.e. limitations must be reasonable and necessary in the particular circumstances, as well as proportionate to the objectives the limitations seek to achieve.

In limited circumstances, the therapeutic goods information specified in the Instrument may include personal information. Such information would possibly include:

the name and contact information of the responsible entity, where the responsible entity is an individual or the contact information refers to an individual; and
the trade name of the good, where this includes the name of an individual (noting that trade names infrequently contain the names, or parts of the names, of sponsors and manufacturers).

As such, the disclosure of the information would not be an arbitrary or unlawful interference with a person’s privacy under Article 17 of the ICCPR, as the disclosure would be reasonable given it is appropriate and justified for the public to know who the responsible entity or manufacturer is (even if it is an individual), and the disclosure would be necessary and proportionate to the objective of promoting the safety of therapeutic goods in Australia.

Conclusion

This legislative instrument is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and any engagement with the right to privacy in Article 17 of ICCPR is reasonable, necessary and proportionate.

Administered by Department of Health, Disability and Ageing

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