Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
C. Notification/initiation of recall
Recall might be initiated as a result of reports referred to sponsors or co-ordinators from a variety of sources. The reports may be referred by manufacturers, wholesalers, retail and hospital pharmacists, blood banks, fractionators, pathology departments, tissue banks, operating and research facilities, medical practitioners, biomedical engineers, dentists and patients. Recall might also be initiated as a result of analysis and testing of samples of therapeutic goods by sponsors and by the Commonwealth and State/Territory testing laboratories; and as a result of advice received from the Australian Drug Evaluation Committee, the Adverse Drug Reaction Advisory Committee, the Medical Device Evaluation Committee, the Medicines Evaluation Committee, the Complementary Medicines Evaluation Committee and other bodies. Recall of goods manufactured overseas might be initiated by reports appearing in FDA Enforcement Reports and similar publications of health authorities, or from information received directly from such authorities.
Certain information is essential to permit the assessment of the validity of the report of a problem with therapeutic goods, the potential danger to consumers and the action appropriate to the situation. Copies of the Medicine Problem Report, Medical Device Incident Report and the Human Blood and Tissues Report Forms are provided at Appendices I, II and III respectively. These forms are used to report problems to the Therapeutic Goods Administration. Manufacturers, sponsors and distributors may also find the forms convenient for reporting problems.
Serious problems which may lead to recall should be reported directly to the TGA for investigation. Reports made to a State/Territory Recall Co-ordinator, with any opinions on toxicological or therapeutic hazards and the action proposed by the State/Territory should be referred on to the appropriate officers in the TGA. These are the Australian Recall Co-ordinator (medicine problems) and the Manager, Medical Device Incident Reporting Scheme (device problems).
When the need for recall has been established, additional information is required so that an appropriate recall strategy may be devised. A summary of the information required is provided in Section E.
Special note on radiopharmaceuticals
A special procedure is used for the initiation of recalls for short-lived radiopharmaceuticals, some of which are distributed before all quality control tests are completed. If such a product is shown not to comply with relevant specifications or if, for some other reason, doubt exists as to the product's quality, safety or efficacy, the head of the distributing organisation's radioactive products section or a nominated deputy must take immediate action to prevent its use by informing users accordingly by telephone or facsimile and seeking acknowledgment. The Australian Recall Co-ordinator should also be advised immediately.
In the case of telephone advice to users of radiopharmaceuticals or when incomplete facsimile advice has been given initially, a facsimile or medicine recall letter giving full details in accordance with Section G, as appropriate, is to be sent to users. The text of the communication is to be approved by the Australian Recall Co-ordinator.