Uniform recall procedure for therapeutic goods (URPTG), 2004 edition

2004 edition

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12 April 2017

L. Commonwealth Therapeutic Goods Act 1989 requirements

The Therapeutic Goods Act 1989 (the Act) was amended in May 2003 to include new recall provisions for therapeutic goods which are regulated under Chapter 3 of the Act. The amendments ensure that similar recall provisions apply under Chapter 3 (relating to medicines, therapeutic devices covered by transitional arrangements and exempt goods) and Chapter 4 (relating to medical devices).

1. Introduction

The Act contains separate but similar recall provisions for therapeutic goods regulated under Chapter 3 and therapeutic goods regulated under Chapter 4.

Therapeutic goods regulated under Chapter 3 include medicines, therapeutic devices covered by transitional arrangements and exempt goods. The recovery provisions for these goods are set out in section 30EA of the Act.

Therapeutic goods regulated under Chapter 4 are medical devices. The recovery provisions for medical devices are set out in section 41KA of the Act.

The Act also contains recovery provisions for therapeutic goods that have been, or could possibly be, subject to actual or potential tampering. These provisions are set out in section 42V of the Act.

2. Recovery of goods regulated under Chapter 3

Section 30EA of the Act provides for public notification and recovery of therapeutic goods to which Chapter 3 applies (medicines and other therapeutic goods that are not medical devices). The powers in section 30EA of the Act are similar to the provisions contained in section 41KA of the Act for medical devices.

In short, section 30EA allows the Secretary to take action where:

  • Therapeutic goods do not conform with applicable standards, or the relevant manufacturing principles have not been complied with;
  • Therapeutic goods have been supplied in contravention of:
    • subsection 20(1) of the Act (ie a person imports, exports, manufactures or supplies therapeutic goods that are not registered or listed, or are not exempt under section 18 or 18A or are not the subject of an approval or authority under section 19 or section 19A); or
    • subsection 42E(1) of the Act (ie a person manufactures or supplies in Australia, or imports into or exports from Australia therapeutic goods that are counterfeit and the person knows that fact or is reckless as to whether that fact exists);
    • The manufacturer is unlicensed; or
    • The registration or listing of the goods has been cancelled.

Depending on the circumstances, either the person supplying the goods or the person in relation to whom the goods are included in the Register may be required by the Secretary to take action in relation to the goods.

The person on whom the Secretary imposes requirements can be required to do one or more of the following:

  • Take specified steps in a specified manner and within the reasonable period specified to recover goods that have been distributed;
  • Inform the public or a specified class of persons what has happened;
  • Publish specified information relating to the manufacture or distribution of the goods.

Recall and associated actions may be limited to specified batches of therapeutic goods. 30 EA (4) recall requirements do not apply to goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person.

Imposition of requirements under section 30EA of the Act does not affect the Secretary's power to cancel the registration or listing of the goods.

When the Secretary takes action under section 30EA of the Act, the Secretary must cause to be published in the Gazette a notice setting out the particulars of the requirements imposed.

Non-compliance with requirements imposed under section 30EA of the Act constitutes an offence punishable on conviction by a maximum penalty of 60 penalty units.

3. Recovery of goods regulated under Chapter 4

Section 41KA provides for the public notification and recovery of medical devices.

The Secretary may take action in relation to medical devices where:

  • The goods are included in the Register but do not comply with the essential principles, or the conformity assessment procedures have not been applied to medical devices of that kind;
  • The goods supplied are exempt devices, or there is an approval under section 41HB (exemptions for special and experimental uses) relating to devices of that kind, or there is an authority under section 41HC (exemptions for medical practitioners) relating to devices of that kind, but medical devices of that kind do not comply with the essential principles, or the conformity assessment procedures have not been applied to medical devices of that kind;
  • The goods supplied are not included in the Register and are not an exempt device, and there is no approval under section 41HB relating to devices of that kind, and there is no authority under section 41HC relating to devices of that kind;
    • The goods have been suspended from the Register; or
    • The goods have been cancelled from the Register.

Depending on the circumstances, either the person supplying the goods or the person in relation to whom the goods are included in the Register may be required by the Secretary to take action in relation to the goods.

The person on whom the Secretary imposes requirements can be required to do one or more of the following:

  • Take specified steps in a specified manner and within the reasonable period specified to recover medical devices that have been distributed;
  • Inform the public or a specified class of persons what has happened.

The imposition of requirements to recover medical devices may be limited to those medical devices of the kind to which the specific circumstances apply.

Recall requirements do not apply to a medical device that cannot be recovered because it has been administered to, or applied in the treatment of, a person.

Imposition of requirements under section 41KA of the Act does not affect the Secretary's powers of suspension and cancellation.

When the Secretary takes action under section 41KA of the Act, the Secretary must cause to be published in the Gazette a notice setting out the particulars of the requirements imposed.

Non-compliance with requirements imposed under section 41KA of the Act constitutes an offence punishable on conviction by a maximum penalty of 60 penalty units.

4. Recall of therapeutic goods that have been or could possibly be, subject to actual or potential tampering

Part 5-3 of the Act concerns product tampering and applies both to Chapter 3 and Chapter 4 therapeutic goods.

Section 42T imposes an obligation on any person who supplies, manufactures or sponsors therapeutic goods to notify the Secretary to the Department for Health or the National Manager of the Therapeutic Goods Administration within 24 hours of becoming aware of a tampering or a substantial risk of actual or potential tampering to those therapeutic goods, or receiving information or a demand relating to actual or potential tampering with the goods.

Failure to notify the Secretary or the National Manager of the Therapeutic Goods Administration is an offence punishable on conviction by a maximum penalty of 400 penalty units.

Section 42V allows the Secretary, if satisfied that there has been actual or potential tampering, to 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 goods that have been, or could possibly be, subject to tampering. The Secretary can also require the person to inform the public or other specified persons of the actual or potential tampering.

The Secretary may impose these requirements whether or not a notification has been made under section 42T.

Where the Secretary takes action under section 42V, the Secretary must cause to be published in the Gazette a notice setting out particulars of the requirements imposed.

Recovery requirements do not apply to a therapeutic good that cannot be recovered because it has been administered to, or applied in the treatment of, a person.

Non-compliance with requirements imposed under section 42V of the Act constitutes an offence punishable on conviction by a maximum penalty of 240 penalty units.

Section 42W of the Act makes it an offence to supply goods in Australia or export goods from Australia that are subject to recovery requirements imposed under Section 42V, unless the Secretary has given written consent and exceptional circumstances exist (maximum penalty: 240 penalty units).

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