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

2004 edition

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12 April 2017

M. Commonwealth Trade Practices Act 1974 requirements

Where a recall is safety-related, (i.e. there is risk of injury or harm to patients), there is a legal requirement under the Commonwealth Trade Practices Act 1974 (the Act) for the sponsor to notify the Commonwealth Minister via the ACCC, within two days of taking recall action.

Three points should be noted in connection with this requirement:

  1. Where the word 'recall' is used in the Act, it refers to both permanent removal of goods from the market (recall) and to temporary removal, correction and return to the market or use (recall for product correction).
  2. The requirement is for notification only; the Procedure as set out in this document is to be used for the actual recall.
  3. The requirement for notification applies only to safety-related recalls and not to purely quality-related recalls (minor labelling deficiencies, marginal sub-potencies etc.). Where the hazard is not clearly assessable, medical or other expert opinion should be sought.

The relevant provisions of the Act can be summarised as follows:

Under Section 65R of the Act, the sponsor of a product being recalled because the goods will or may cause injury to any persons must notify in writing the responsible Minister (via the ACCC) of the recall within two days of taking that action.

Notification must:

  1. state that the goods are subject to recall; and
  2. set out the nature of the defect in, or dangerous characteristic of, the goods.

Address:

Recall Co-ordinator
Product Safety Policy Section
Australian Competition and Consumer Commission
PO Box 1199
Dickson ACT 2602
E-mail: recalls@recalls.gov.au
Facsimile: 02 6243 1171

Under Section 65F (7) of the Act, where goods which have been exported are recalled, a company is required to notify in writing, as soon as practicable, overseas recipients of the recalled stock.

Notification must:

  1. state that the goods are subject to recall; and
  2. if the goods contain a defect, have a dangerous characteristic or do not comply with a prescribed consumer product safety standard, set out the nature of the problem or in the latter case, the nature of non-compliance.

The company must provide a copy of the overseas notification letter(s) or facsimile(s) to the Minister (via the ACCC) within 10 days of sending such notification.

Failure to notify the Minister of a safety related recall within two days of taking that action, or failure to provide the Minister within ten days with a copy of notice sent to an overseas client advising of recall, have penalties of up to $15,000 for a corporation or a fine up to $3,000 for an individual.

Suppliers should also note that the Act empowers the Minister responsible to impose a mandatory recall if a supplier has not taken satisfactory action to remove the hazard created by the goods. Section 65L of the Act allows the Minister to order an immediate recall of goods if the goods create an imminent risk of death, serious illness, or serious injury. This power has been used to order recall of therapeutic goods. A corporation convicted of a failure to comply with a mandatory recall may be fined up to $200,000 and an individual in a contravention up to $40,000.

In order to advise the Minister that recalls have been completed satisfactorily, the Product Safety Policy Section of the Australian Competition and Consumer Commission, in consultation with the Therapeutic Goods Administration, Department of Health, may conduct product recall audits. Suppliers should therefore ensure that adequate documentary evidence and other written records are maintained in respect of safety-related recalls.

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