Sponsors of therapeutic goods are encouraged to decide of their own accord, or after recommendation from the TGA, that the recall of a particular product is necessary in order to mitigate an actual or potential deficiency in relation to its safety, quality, performance or efficacy.

However, if necessary the Delegate of the Secretary of the Australian Department of Health (the Secretary) can exercise powers under the Therapeutic Goods Act 1989 to mandate the sponsor^[11] to recall therapeutic goods to protect public health.

On this page: Legislative basis for mandatory recalls | Recovering goods | Action by a TGA delegate | Failure to comply with mandatory recalls | Counterfeit therapeutic goods | Actual or potential tampering

Legislative basis for mandatory recalls

The circumstances for mandating a recall are set out in the Therapeutic Goods Act 1989.

• Medical devices: go to Chapter 4, Part 4-9, s41KA - 41KD.
• Medicines and other therapeutic goods (OTGs): go to Chapter 3, Part 3-2, Division 2A, s30EA - 30ED.
• Biologicals: go to Chapter 3, Part 3-2A, Division 8, s32HA - 32HE.

Related information and guidance

ACCC and recalling goods for statutory obligations under the ACL.

A TGA delegate of the Secretary can also impose requirements to recall:

• counterfeit therapeutic goods
• therapeutic goods that have been or could possibly be, subject to actual or potential tampering.

These requirements do not apply to goods that cannot be recalled because they have been administered to, or applied in the treatment of, a person.

In this section: Medical device and IVDs | Medicines and other therapeutic goods | Biologicals mandatory recalls

Medical device and IVDs

A TGA delegate of the Secretary can require the recall of medical devices from the supply chain when a kind of medical device:

• on the ARTG:
  • does not comply with the essential principles
  • has not been manufactured under the applicable conformity assessment procedures
  • appears to be unacceptable in relation to its quality, safety, or performance
• exempt from requiring entry on the ARTG or is the subject of an approval or authority to enable lawful supply while not on the ARTG:
  • does not comply with the essential principles
  • the manufacturer has not applied the applicable conformity assessment procedures
  • if exempt under the 'emergency' exemption: is not fit to use for its intended purpose
• is supplied, but is not either on the ARTG or exempt from having to be entered on the ARTG, and is not the subject of an approval or authority to enable lawful supply while not on the ARTG
• has been cancelled or suspended from the ARTG.

The requirement to recall a kind of medical device may only relate to some medical devices of that kind.

The exercise of recall powers under these provisions does not affect powers to suspend or cancel entries of kinds of medical devices, under other Parts of the Act.

Medical devices that do not meet requirements

There are criminal offences and civil penalty provisions relating to medical devices under Chapter 4, Part 4-11 of the ActTherapeutic Goods Act 1989 when:

• Persons import, supply or export medical devices that do not meet the essential principles.
• Manufacturers of medical devices supplied in Australia did not apply appropriate conformity assessment procedures.

There may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited time. If this happens, sponsors may seek consent to import, supply or export medical devices that do not meet an Essential Principle.

There are no similar provisions when the manufacturer has not applied the appropriate conformity assessment procedures to manufacture medical devices.

Medicines and other therapeutic goods

A TGA delegate of the Secretary can require the recall of medicines or other therapeutic goods (OTGs) from supply when:

• A medicine or OTG, (whether registered, listed or exempt from having to be entered onto the ARTG), or the subject of an approval or authority to be supplied while not on the ARTG either:
  • does not comply with an applicable standard
  • is not manufactured according to the manufacturing principles
• A medicine or OTG is illegally supplied (i.e. it is not registered or listed on the ARTG and it is not exempt from having to be entered onto the ARTG, or the subject of an approval or authority to be supplied while not on the ARTG)
• A medicine or OTG is on the ARTG but either:
  • An unlicensed manufacturer carried out one or more manufacturing steps
  • It appears that the quality, safety, efficacy or presentation of the medicine is unacceptable
  • A medicine or OTG has been cancelled or suspended from the ARTG.

The requirement to recall a medicine or OTG may relate to specified batches.

Medicines that do not meet requirements

There are criminal offences and civil penalty provisions under Chapter 3, Part 3-1, section 14 and 14A of the Therapeutic Goods Act 1989 for importing, supplying or exporting medicines and OTGs that do not comply with standards unless with the consent of the Secretary.

Related guidance

Counterfeit therapeutic goods

Biologicals mandatory recalls

A TGA delegate of the Secretary can require biologicals to be recalled from supply when:

• A biological, whether included on the ARTG or exempt from having to be entered onto the ARTG, or the subject of an approval or authority to be supplied while not on the ARTG either:
  • does not comply with applicable standards.
  • has not been manufactured according to the manufacturing principles (not applicable to Class 1 biologicals).
• A biological exempt from having to be entered onto the ARTG under the 'emergency' exemption is not fit to be used for its intended purpose.
• A biological is illegally supplied (i.e. supplied and it is not included on the ARTG, is not exempt from having to be entered onto the ARTG, and is not the subject of an approval or authority to be supplied while not on the ARTG).
• A biological (other than a Class 1) supplied while on the ARTG but there is a breach of the condition that:
  • The biological be manufactured by the holder of an Australian licence.
  • If manufactured overseas, the biological has been certified to have been made under acceptable manufacturing procedures.
• It appears that the quality, safety or efficacy of the goods that is a biological is unacceptable or that the presentation of the biological is unacceptable.
• The goods have been suspended or cancelled from the ARTG.

Biologicals that do not meet requirements

Chapter 3, Part 3-2A, Division 2 of the Act contains criminal offences and civil penalties relating to the import, export, manufacture, supply and use of biologicals in certain circumstances.

Related guidance

Counterfeit therapeutic goods

Action by a TGA delegate

Under the mandatory recall provisions, a TGA delegate can require the sponsor or Australian manufacturer to either/or:

• Take specified steps, in a specified manner and within such reasonable period as is specified to recall the goods.
• Inform the public or a specified class of persons, in a specified manner and within such reasonable period in relation to the issues and/or publish specified information.
• Inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind in relation to the goods and/or the issues.
• Publish, in a specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of goods.

Notify the TGA delegate, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom the goods have been supplied. To achieve this, a TGA delegate can require the sponsor to follow requirements of this procedure or a different set of instructions.

A TGA delegate can also require the same person to inform the public (or a specified class of persons) what is happening, or has happened, and why.

Publishing of mandatory recalls

The requirements a TGA delegate imposes on a person to recall therapeutic goods from supply must be published in the Australian Government Notices Gazette or on the TGA website.

Failure to comply with mandatory recalls

If a person fails to comply with a requirement imposed to recall a therapeutic good or take other action under the mandatory recall provisions, then depending on the circumstances he or she may:

• be charged with a criminal offence and, if found guilty of that offence by a Court:
  • imprisoned for up to 12 months (or 5 years, if failure to recall the therapeutic goods results in harm or injury to another person)
  • be subject to fines ranging from 1000 to 4000 penalty units.
• Have civil penalty proceedings brought against them in a Court, and, if the Court finds the breaches made out, be ordered to pay various civil penalties.

Counterfeit therapeutic goods

A TGA delegate may require a person who supplies counterfeit therapeutic goods to recall those goods from supply, or take other actions such as public notification (sections 30EA, 32HA and 42E of the Therapeutic Goods Act 1989).

Therapeutic goods are counterfeit if the label or presentation of the goods; any document or record relating to the goods or their manufacture; or any advertisement for the goods; contains false information relating to the:

• identity or name of the goods
• formulation, composition or design specification of the goods or of any ingredient or component
• presence or absence of any ingredient or component of the goods
• strength or size of the goods (other than the size of any pack in which the goods are contained)
• strength or size of any ingredient or component of the goods
• sponsor, source, manufacturer or place of manufacture of the goods.

Actual or potential tampering

Any person who supplies, manufactures or sponsors therapeutic goods, or proposes to do so, must notify TGA within 24 hours of becoming aware of a substantial risk of actual or potential tampering to those therapeutic goods.

It is an offence under section 42T of the Therapeutic Goods Act 1989, punishable by imprisonment of up to 12 months or a fine of up to 1000 penalty units, or both if

• they^[12] receive information or demands and know it relates (either expressly or by implication) to actual or potential tampering with some or all of those therapeutic goods, or any other therapeutic goods

AND

• fail to notify the TGA within 24 hours after receiving information or demand.

How to notify

Address your notification to the Principal Medical Adviser, c/- the Australian Recall Coordinator.

Email the notification to recalls@health.gov.au.

Specifying steps for actual or potential tampering

If satisfied that there has been actual or potential tampering, a TGA delegate can require a person who supplies or has supplied the therapeutic goods, or a particular batch or kind of therapeutic goods, to:

• Take action to recall the goods that have been, or could possibly be, subject to tampering.
• Inform the public or other specified persons of the actual or potential tampering.

TGA may impose these requirements under Section 42V of the Therapeutic Goods Act 1989, whether or not a notification has been made.

Publishing of tampering requirements

When TGA takes action under section 42V of the Therapeutic Goods Act 1989, the particulars of the requirements imposed must be published in the Australian Government Notices Gazette or on the TGA website.