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Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
A. Preamble and definitions
The Uniform Recall Procedure for Therapeutic Goods (the 'Procedure') is the result of an agreement between the therapeutic goods industry and Commonwealth and State/Territory health authorities. Its purpose is to define the action to be taken by health authorities and sponsors when therapeutic goods for use in humans, for reasons relating to their quality, safety or efficacy, are to be removed from supply or use, or subject to corrective action. It should be noted that in this document 'quality' means compliance with statutory or agreed standards rather than grade of materials and workmanship.
The Commonwealth, each State, the Northern Territory and the Australian Capital Territory health authorities each nominate an officer and a deputy through whom information relating to product recall will be channelled and co-ordinated. Overall responsibility for co-ordination of recalls lies with the Australian (Commonwealth) Recall Co-ordinator, who is an officer of the Therapeutic Goods Administration (TGA), Australian Department of Health.
Each sponsor of therapeutic goods should advise the Australian Recall Co-ordinator of the names, after-hours addresses and telephone numbers of two persons in the sponsor company who have authority to discuss and, if necessary, implement a recall (see Appendix VI).
When the need for a recall has been established, the sponsor of the affected goods assumes the responsibility for recovery of the goods, or corrective action, while the Australian Recall Co-ordinator assists by advising the sponsor of the procedures, by notifying agreed third parties and by monitoring the overall action.
Most recalls are not mandated but are sponsor initiated. However, the Procedure is underpinned by the Therapeutic Goods Act 1989 and the Trade Practices Act 1974. In terms of the Therapeutic Goods Act 1989, mandatory recall provisions can be applied when therapeutic goods are cancelled from the Australian Register of Therapeutic Goods; or where therapeutic goods are unlawfully supplied in Australia; or where therapeutic goods fail to comply with a standard (see Section L for details.) The Trade Practices Act 1974 contains provisions in relation to the safety-related recall of consumer goods. The relevant parts of the Act, which are administered by the Product Safety Policy Unit, Australian Competition and Consumer Commission (ACCC) empower the Commonwealth Minister responsible for Consumer Affairs to take action when notification is not made of safety-related recalls, or where the recall has not been satisfactorily completed (see Section M for details).
The Procedure is recognised by the ACCC as being appropriate to the specialised requirements for the recall of therapeutic goods. Its use is therefore, in effect, obligatory in relation to safety-related recalls of therapeutic goods.
Where recall is refused, or is not carried out satisfactorily, the Minister may order a mandatory recall. Failure to comply with such an order may result in substantial fines.
Relevant parts of the Procedure may also be used by sponsors for the purpose of disseminating emergency information on the safe use of therapeutic goods. This will normally be restricted to situations involving a significant safety factor and where distribution of the affected goods has been on a national scale.
Recall is an action taken to resolve a problem with therapeutic goods for which there are established deficiencies in quality, efficacy or safety.
Two distinct types of recall are included in this Procedure:
- permanent removal of deficient goods from the market or from use; and
- correction, which may involve temporary removal from the market or from use.
These are designated Recall and Recall for Product Correction respectively.
Recall - means the permanent removal of therapeutic goods from supply or use for reasons relating to deficiencies in the quality, safety or efficacy of the goods.
- requests to pharmacists, hospitals, pathology laboratories, fractionators, operating and research facilities, biomedical engineers or others to check and return goods found to be defective; and
- removal from supply or use of goods with inherent design or manufacturing defects.
It does not include:
- removal of time-expired goods; and
- removal of appropriate numbers of goods to determine whether there are deficiencies relating to quality, safety or efficacy.
Recall for Product Correction - means the repair, modification, adjustment or re-labelling of therapeutic goods for reasons relating to deficiencies in the quality, safety or efficacy of the goods. The corrective action may take place at the user's or the sponsor's premises or any other agreed location.
- corrections involving a product's expiry date; and
- changes to any accessories, operating instructions or software, correcting deficiencies relating to the quality, safety or efficacy of the goods or outputs.
- Field corrections
It does not include:
- removal of individual goods for repair in the event of malfunction or failure as a result of normal wear and tear or for appropriate maintenance or due to lack of good maintenance; and
- removal of individual goods for modification due to technical improvements other than when these improvements overcome an inherent design or manufacturing defect.
Hazard Alert - means the issuing of precautionary information about an implanted device where it has been proven that there is no stock to be recalled and all affected devices are already implanted (this category only relates to implantable medical devices).
Sponsor - is the person, business or company that has the primary responsibility for the supply, including for clinical investigational use, of the product in Australia. The sponsor may also be the manufacturer of the goods.
Therapeutic Goods means goods:
- that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
- for therapeutic use; or
- for use as an ingredient or component in the manufacture of therapeutic goods; or
- for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
- included in a class of goods the sole or principal use of which is, or ordinarily is a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);
and includes goods declared to be therapeutic goods under an order in force under section 7 of the Therapeutic Goods Act 1989, but does not include:
- goods declared not to be therapeutic goods under an order in force under section 7 of the Therapeutic Goods Act 1989; or
- goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or
goods for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991; or
- goods which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.
Therapeutic Use - means use in or in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
- influencing, inhibiting or modifying a physiological process in persons or animals; or
- testing the susceptibility of persons or animals to a disease or ailment; or
- influencing, controlling or preventing conception in persons; or
- testing for pregnancy in persons; or
- the replacement or modification of parts of the anatomy in persons or animals.
Supply - includes:
- supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase; and
- supply, whether free of charge or otherwise, by way of sample or advertisement; and
- supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons or animals; and
- supply by way of administration to, or application in the treatment of, a person or animal.
Safety Alert, Product Notification, Withdrawal and Recovery are four associated actions which are not recall actions, and are therefore not subject to this Procedure (Note: Hazard Alerts are considered to be recall actions which are subject to the Procedure). Where the sponsor is unsure of the appropriate action to be taken, and particularly in cases where patient safety may be a consideration, the issues involved should be discussed with the Australian Recall Co-ordinator.
Safety Alert - means advice regarding a specific situation with respect to a therapeutic good which, whilst performing to meet all specifications and therapeutic indications, might present an unreasonable risk of substantial harm if certain specified precautions in regard to its use are not observed.
Safety Alerts are intended only to provide information on safe use of therapeutic goods, as distinct from recall action which addresses product deficiencies. As patient safety is a factor in both, sponsors are encouraged to distribute Safety Alerts with a minimum of delay.
As mentioned in the Preamble, sponsors may, if they wish, use appropriate sections of the Procedure to assist in the dissemination of Safety Alert information. Copies of Safety Alerts should be forwarded to the Australian Recall Co-ordinator for distribution to the State/Territory health authorities for their information.
Product Notification - means the issue of precautionary information about a therapeutic good, in a situation that is unlikely to involve significant adverse health consequences.
Withdrawal - means a sponsor's removal from supply or use of therapeutic goods for reasons not related to their quality, safety or efficacy.
Recovery (for purposes of this document) - means a sponsor's removal of therapeutic goods from sale or supply that have not already been supplied by the sponsor.