TGA Updates Guidance on Consent for Therapeutic Goods That Do Not Comply with Standards

The Australian Therapeutic Goods Administration (TGA) updated its industry guidance on 28 October 2026, revising the list of standards specified under Section 10 of the Therapeutic Goods Act 1989. The guidance explains the requirements and procedures for obtaining consent to import, supply, or export therapeutic goods that do not comply with applicable standards.

Under Australian legislation, therapeutic goods must comply with the standards applicable to them. Importing, supplying, or exporting non-compliant goods without prior written consent from the Secretary is an offence under Section 14 of the Act, while Section 14A establishes the associated civil penalty provisions.

The guidance outlines the products covered by these requirements, the application process, the information applicants must provide, and the factors considered by the TGA when assessing requests.

Scope of Sections 14 and 14A

Sections 14 and 14A apply to therapeutic goods registered or listed in the Australian Register of Therapeutic Goods (ARTG) under Part 3-2 of the Act. These include:

• Registered and listed medicines.
• Registered and listed therapeutic devices.
• Export-only listed therapeutic goods.

The provisions also cover certain therapeutic goods that are exempt from registration or listing but remain subject to standards under Section 10. Examples include blood and blood components manufactured by the holder of a licence to manufacture these products, and medicines exempt from registration or listing because they have been extemporaneously compounded for a particular person or otherwise approved under Part 3-2, such as under Section 19A.

The requirements also apply to biologicals included in the ARTG under Part 3-2A and to certain biologicals exempt from inclusion or otherwise approved under that Part. However, they do not apply to biologicals that meet the exceptional release circumstances specified in Regulation 33A of the Therapeutic Goods Regulations.

Medical devices are excluded from this consent process. Applications concerning medical devices that do not comply with the Essential Principles follow a separate TGA procedure.

What Constitutes an Applicable Standard?

For the purposes of this guidance, an applicable standard may be established through an order made by the Minister under Section 10 of the Act or through relevant pharmacopoeial monographs.

The recognised pharmacopoeial standards include:

• British Pharmacopoeia (BP).
• European Pharmacopoeia (Ph. Eur.).
• United States Pharmacopeia–National Formulary (USP–NF).

The TGA identifies several Therapeutic Goods Orders (TGOs) made under Section 10 that are likely to be relevant to consent applications. These include:

• TGO 100 – Therapeutic Goods (Microbiological Standards for Medicines) Order 2018.
• TGO 101 – Therapeutic Goods (Standard for Tablets, Capsules and Pills) Order 2019.
• TGO 102 – Therapeutic Goods (Standard for Blood and Blood Components) Order 2019.
• TGO 107 – Therapeutic Goods Order (Standard for Biologicals – Labelling Requirements) Order 2021.
• TGO 108 – Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) Order 2021.
• TGO 110 – Therapeutic Goods (Standard for Therapeutic Vaping Goods) Order 2021.
• TGO 115 – Therapeutic Goods (Standard for Labelling of Prescription Medicines) Order 2026.
• TGO 116 – Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) Order 2026.

The applicable standard depends on the product and the specific requirement with which it does not comply.

How to Obtain Consent

Any person in relation to whom a medicine or other therapeutic good is included in the ARTG under Part 3-2 of the Act, or a biological is included under Part 3-2A, may submit an application to the TGA.

An application may cover multiple ARTG entries, provided that:

1. The circumstances relevant to granting consent are the same for all the goods included in the application.
2. The non-compliance relates to the same part or parts of an applicable standard.

For example, a single application may cover multiple ARTG entries involving products that do not comply with the expiry-date prefix requirement under paragraph 8(1)(g) of TGO 91 or TGO 92.

Applicants seeking to import, supply, or export exempt or otherwise approved products that do not comply with an applicable standard should contact the TGA.

Application Fees

The TGA will not consider an application unless the relevant processing fee has been paid.

The fee is payable for each application under Item 1A, Part 1 of Schedule 9 of the Therapeutic Goods Regulations 1990. Therefore, one fee may cover multiple ARTG entries when the conditions for combining products in a single application are met.

The guidance also specifies that a processing fee applies to applications for consent relating to biologicals.

Information Required for an Application

Applicants are responsible for providing sufficient information to satisfy the TGA that consent should be granted.

The application should identify:

• The specific part or parts of the applicable standard with which the product does not comply.
• The relevant products, including batch numbers where applicable.
• The circumstances that resulted in the non-compliance.
• The risks associated with the non-compliance and the steps being taken to address them. These may include a proposed letter to healthcare professionals.
• The potential impact on the immediate and future supply of compliant goods if consent is not granted, where a supply shortage may occur.

Where relevant, applicants should also explain how long the non-compliance is expected to continue, including the period or batches for which consent is requested. They should describe the strategies planned to rectify the non-compliance and the expected timeframe for implementing those measures.

The TGA may request additional information when necessary to assess an application.

Providing false or misleading information for the purpose of an application under Section 14 or Section 14A is a serious offence under Sections 136 and 137 of the Commonwealth Criminal Code.

Factors Considered During TGA Assessment

The TGA considers whether granting consent could adversely affect the safety, quality, or efficacy of the therapeutic good, or its safe and effective use.

Consent will not be granted unless the decision-maker is satisfied that these considerations will be adequately addressed, whether through the imposition of conditions or other measures.

The factors that may be considered include:

• The clinical need for uninterrupted supply and the availability of suitable alternatives.
• Whether appropriate conditions can sufficiently mitigate the risks associated with the non-compliance.
• Whether consent should be limited to a specific period or number of batches.
• Whether the circumstances leading to the non-compliance were foreseeable or avoidable.

These considerations allow the TGA to assess the circumstances of the non-compliance alongside potential risks and the implications for product availability.

Duration of Consent

Consent may apply to specific batches, be limited to a defined period, or include both limitations.

The TGA generally does not grant consent for periods longer than two years. However, longer periods may be considered in exceptional circumstances.

Regardless of the requested duration, applicants must provide justification for the proposed period in their application.

Conditions Imposed on Consent

Under Section 15 of the Therapeutic Goods Act 1989, TGA delegates may impose conditions intended to mitigate risks and ensure that the safety, quality, and efficacy of the product, or its safe and effective use, are not adversely affected.

When determining these conditions, consideration is also given to the information that needs to be provided throughout the supply chain to support the safe use of the product.

Breaching a condition imposed on a consent is an offence under Section 15 and may also result in civil penalties under Section 15AA of the Act.

Publication of Consent Decisions

The TGA is required to publish details of granted consents in the Commonwealth Gazette or on its website.

Previously, consent decisions were published in the Gazette. Since 1 February 2016, these decisions have been published in a searchable format on the TGA website and remain accessible there.

Where an application is refused, the TGA must notify the sponsor within 28 days and provide the reasons for the decision. Refusal decisions are not required to be published.

Rights of Review

Applicants have the right to request an internal review under Section 60 of the Therapeutic Goods Act 1989.

In the case of a refusal, the Secretary must notify the applicant within 28 days of making the decision and provide the reasons. The applicant may request an internal review within 90 days after receiving notification.

The right to internal review also applies to decisions to impose conditions on a consent under Section 15. Applicants may request a review within 90 days of being informed of the decision.

Following an internal review, applicants may also seek review by the Administrative Appeals Tribunal. Details of the available review rights are included in the notices issued to applicants.

Reporting of Medicine Shortages

The guidance also addresses applications intended to mitigate medicine shortages.

Sponsors may request priority review of a Section 14 consent application when the purpose is to address a shortage of a reportable medicine, provided that they have submitted a medicine shortage notification to the TGA.

This provision links the consent process with the TGA’s medicine shortage reporting arrangements.

Distinguishing Section 14 Consent from Market Actions

The TGA clarifies that the Section 14/14A consent process and the Procedure for Recalls, Product Alerts and Product Corrections (PRAC) generally apply at different stages of the supply chain.

Section 14/14A consent applies to non-compliant therapeutic goods that are:

• Still overseas.
• Located within Australia but not yet supplied further.
• Held by the sponsor.

PRAC market action procedures apply when non-compliant products have already been supplied to distributors, suppliers, hospitals, or patients.

However, both processes may be necessary in certain circumstances.

For example, if a medicine defect is identified after the product has been supplied, a market action may be required, such as a product alert or product correction. At the same time, the sponsor may need to maintain supply of remaining stock or future batches that do not comply with an applicable standard. In this situation, a Section 14/14A consent application may also be required.

Both processes aim to protect patient safety while maintaining continuity of supply. The TGA emphasizes that sponsors should maintain clear records and communicate with the agency throughout these processes.

Regulatory Considerations for Pharmaceutical Sponsors

The guidance highlights the importance of identifying applicable standards, documenting non-compliance, assessing associated risks, and preparing appropriate corrective measures when seeking consent.

For pharmaceutical companies operating in Australia, these activities form part of broader regulatory compliance and product lifecycle management responsibilities. Understanding local requirements is particularly important for overseas companies working with Australian sponsors and maintaining products included in the ARTG.

Baupharma supports pharmaceutical companies with regulatory activities related to Australian market entry, regulatory submissions, and ongoing compliance. Its Australia pharmaceutical market entry article provides further context on the regulatory considerations involved in entering the Australian market.

Conclusion

The TGA’s guidance explains the requirements for obtaining consent to import, supply, or export therapeutic goods that do not comply with applicable Australian standards.

It covers the scope of Sections 14 and 14A, the standards that may apply, application eligibility and supporting information, assessment considerations, and the conditions and limitations that may accompany granted consent.

It also clarifies the distinction between the consent process and market action procedures, helping sponsors understand which regulatory pathway may apply depending on the status and location of non-compliant products within the supply chain.

Companies should consult the full TGA guidance and relevant legislation when determining the appropriate regulatory pathway for their products.

Official source: TGA – Consent to import, supply or export therapeutic goods that do not comply with standards: Information for industry.