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Mandatory recall actions

27 October 2015

Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

In certain circumstances, the TGA can require a sponsor (or other appropriate responsible entities) to conduct a mandatory recall to protect the public from a deficient product in accordance with the Therapeutic Goods Act 1989 (the Act).

When is a mandatory recall imposed?

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 safety, quality, performance or efficacy.

However, if necessary the delegate of the Secretary of the Commonwealth Department of Health (the Secretary) can exercise powers under the Act to mandate a recall to protect the public from a deficient product. In these situations the TGA may compel the sponsor or other responsible entities to follow the procedure described in the Uniform Recall Procedure for Therapeutic Goods.

The circumstances in which the TGA can mandate recall actions are specific for medicines, medical devices, and biologicals and are set out in the following sections of the Act.

The TGA can also impose requirements to recover products from supply which are counterfeit therapeutic goods or therapeutic goods that have been or could possibly be, subject to actual or potential tampering under the Act.

The sponsor also has statutory obligations under the Competition and Consumer Act 2010, which are outlined in ACCC and the recall of therapeutic goods.

The next sections summarise the circumstances in which the TGA can require a mandatory recall, for each of medical devices, medicines and biologicals. Please note that the descriptions below are summaries only. You should have regard to the relevant provisions of the Act for complete details of all the circumstances in which recalls can be mandated.

Medical devices

The TGA can require a sponsor to recover their medical device from the supply chain when any of the following circumstances exist:

  • a kind of medical device is included in the ARTG and:
    • does not comply with the essential principles, or the applicable conformity assessment procedures have not been applied
    • it appears to the Secretary that the quality, safety, or performance of that kind of medical device is unacceptable
  • a kind of medical device is exempt from having to be entered onto the ARTG or is the subject of an approval or authority to be supplied whilst not on the ARTG, and:
    • does not comply with the essential principles, or the conformity assessment procedures have not been applied
    • if exempt under the 'emergency' exemption: is not fit to be used for its intended purpose
  • a kind of medical device is 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 whilst not on the ARTG
  • a kind of medical device has been cancelled or suspended from the ARTG.

The requirement to recover 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 the TGA's powers to suspend or cancel entries of kinds of medical devices, under other Parts of the Act.

Import, supply or export of 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 Act when:

  • persons import, supply or export medical devices that do not meet the essential principles
  • manufacturers and sponsors of medical devices supplied in Australia did not meet appropriate conformity assessment procedures.

There may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time. In such circumstances, sponsors may seek consent to import, supply or export medical devices which do not meet an Essential Principle. There are no similar provisions for medical devices that failed to meet appropriate conformity assessment procedures.

Medicines and other therapeutic goods

The TGA can require a sponsor to recover their medicine or OTGs from supply when any of the following circumstances exist:

  • a medicine or OTG, whether registered or listed on the ARTG or exempt from having to be entered onto the ARTG, or the subject of an approval or authority to be supplied whilst not on the ARTG:
    • does not comply with an applicable standard
    • is not manufactured in accordance with the manufacturing principles
  • a medicine or OTG is supplied and 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 whilst not on the ARTG
  • a medicine or OTG is registered or listed on the ARTG but one or more steps in the manufacture of the medicines has been carried out by an unlicensed manufacturer, or 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 recover a medicine or OTG may relate to specified batches of the medicine.

Import, supply or export of 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 Act for importing, supplying or exporting medicines and OTGs that do not comply with standards unless exempt by the secretary.

Biologicals

The TGA can require a sponsor to recover their products that are biologicals from supply when any of the following circumstances exist:

  • a product that is 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 whilst not on the ARTG:
    • does not comply with applicable standards
    • has not been manufactured in accordance with the manufacturing principles (not applicable to Class 1 biologicals)
  • a product that is 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 product that is a biological is 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 whilst not on the ARTG
  • a product that is a biological (other than a Class 1 biological) is supplied whilst 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 (to the Secretary) that the quality, safety or efficacy of the product that is a biological is unacceptable or that the presentation of the biological is unacceptable
  • the products have been suspended or cancelled from the ARTG.

Import, export, manufacture, supply or use of 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.

Who does a mandatory recall apply to?

A mandatory recall can apply to following entities.

  • For therapeutic goods that are or were included on the ARTG, the sponsor of the goods at the time that they were supplied.
  • For therapeutic goods that are exempt from inclusion on the ARTG, the person that initially supplies the goods.
  • For therapeutic goods cancelled/suspended/not included on the ARTG and not exempt, the person who supplied the product.

Action by the TGA

Specifying steps to recall deficient therapeutic goods

Under the mandatory recall provision the TGA can require the responsible entity to:

  • take specified steps, in the specified manner and within such reasonable period as is specified
  • recover products or to inform the public or a specified class of persons, in the specified manner and within such reasonable period in relation to the specific issues identified in the provisions.

To achieve the above requirements, the TGA can require the responsible entity to follow the Uniform Recall Procedure for Therapeutic Goods or a different set of instructions.

In addition to requiring a person to recover therapeutic goods from the supply chain, the Secretary can 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

When the TGA imposes requirements on a person to recover therapeutic goods from supply, these requirements must be published in the Commonwealth Government Notices Gazette (the Gazette) or notified on the TGA's website.

Failure to comply with mandatory recalls

If a person fails to comply with a requirement imposed by the Secretary to recover 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 recover 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

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

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 of them
  • 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 is required to notify the TGA within 24 hours of when any of the following circumstances exist:

  • they become aware of a substantial risk of actual or potential tampering to those therapeutic goods
  • they receive information or a demand relating to actual or potential tampering with the goods.

This requirement is outlined in Section 42T of the Act. It is a criminal offence, punishable by imprisonment of up to 12 months or a fine of up to 1000 penalty units, not to do so, where the person knew or was reckless as to fact that the goods are or have been subject to actual or potential tampering.

How to notify

Notifications should be addressed to the Principal Medical Adviser, c/- the Australian Recall Coordinator and sent by email.

Specifying steps for actual or potential tampering

If satisfied that there has been actual or potential tampering, the TGA 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 recover the products that have been, or could possibly be, subject to tampering
  • inform the public or other specified persons of the actual or potential tampering.

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

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

Publishing of tampering requirements

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

Version history

Version Description of change Author Effective date
V1.0

Publication for consultation

Content taken from the URPTG - Uniform Recall Procedure for Therapeutic Goods

Therapeutic Goods Administration 27 October 2015