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Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
H. Responsibilities of sponsors
Sponsors, and persons with responsibilities for the supply of Human Blood and Tissues products,have responsibilities in relation to recall of therapeutic goods in two general areas:
- in maintaining records and establishing procedures which will assist in facilitating recall should such action become necessary; and
- in taking the prime responsibility for implementing recall in the situation where it is necessary.
In accordance with the requirements of the relevant Manufacturing Principles and the Standard Conditions Applying to Registered or Listed Therapeutic Goods under Section 28 of the Therapeutic Goods Act 1989, sponsors should maintain records for the products manufactured by them in accordance with the following:
- A system should be in operation whereby the complete and up-to-date histories of all batches of products from the starting materials (in the case of a medical device, all components) to the finished products are progressively recorded.
- The system should allow the determination of utilisation and disposal of all starting materials (in the case of a medical device, all components) and bulk products.
- For products having an expiry period, the complete records pertaining to manufacture should be retained for at least one year after the expiry date of the batch; otherwise, the complete records pertaining to the batch should be retained for at least six years after the date of its manufacture noting that other legislature requirements may impose much greater periods.
All sponsors should maintain records of problem reports received about each product. Problem reports should be evaluated by competent personnel and appropriate action taken. The evaluation of each report and the action taken should be shown in the records.
It is a requirement of the Therapeutic Goods Act 1989 for sponsors to retain records of the distribution of registered/listed goods for a period of five years.
All records should be readily available and easy to follow so as to expedite recall whenever necessary.
The Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use sets out appropriate procedures for wholesaler distributors so that there is effective, efficient and safe handling, storage and distribution of such products. It is in the sponsor's interest to encourage their wholesalers to follow this Code
Sponsor recall procedure
As mentioned in Section B, sponsors should prepare procedures for recall action which are consistent with this Procedure and which are applicable to their own operations.
All senior personnel should be familiar with their responsibilities in connection with the procedure and of the records system for products.
Where evaluation of a problem report concerning therapeutic goods indicates that recall may be necessary, the report must be conveyed with the least possible delay to the Australian Recall Co-ordinator, including goods that have been exported - only and not supplied in Australia. Any batch of a formulated product that has been distributed, or any batch of a starting material that is found not to comply with the approved sponsor's specifications or a relevant standard of the Commonwealth Therapeutic Goods Act 1989 (or complementary State/Territory legislation), must also be reported if it has been used in a distributed product.
The sponsor has the prime responsibility for implementing recall action, and for ensuring compliance with the recall procedure at its various stages (Section B). However, no recall, regardless of level, should be undertaken without consultation with the Australian Co-ordinator and without agreement on the recall strategy.
In cases of significant hazard to consumers, company personnel may be utilised to immediately disseminate information on the recall. This includes telephone advice to quarantine stock pending recall or possible recall. This advice should be based on the agreed text of the recall letter or facsimile, which must always be sent as confirmation of oral advice.
Company representatives (medical detailers and sales representatives) may be utilised to recover stock which is the subject of recall, providing the provisions of State/Territory and any applicable Commonwealth regulations are observed in relation to unauthorised possession of certain stock, e.g. medicines of addiction and restricted substances, and suitable recall letters in compliance with Section G are despatched.
For recall in which distribution to outlets such as supermarkets, health food stores and family planning clinics has taken place, the sponsor is to insert, as quickly as possible, paid and approved advertisements in the daily print media of each State/Territory in which distribution may have occurred (Section G), unless complete and accurate distribution lists are available.
For consumer level recall action, the sponsor is to insert, as quickly as possible, paid and approved advertisements in the daily print media of each State/Territory in which distribution may have occurred (Section G). The sponsor is to prepare a recall letter (Section G) for distribution to wholesalers and retailers upon approval of the text by the Australian Recall Co-ordinator.
Sponsors may also be required to notify overseas recipients of recall actions that affect them (Section M).
Sponsors should keep relevant wholesalers advised of the recall. The recall can involve wholesalers in considerable time and expense in issuing credit notes, handling returned stock and forwarding replacements.
Sponsors should be aware that the Commonwealth Minister responsible for Consumer Affairs may, under section 65F of the Trade Practices Act 1974, order suppliers to recall goods if it appears the supplier has not taken satisfactory action to prevent the goods causing injury to any person. This power applies not only to situations where the supplier has not taken any action to reduce risk to the public, but also where a supplier has taken action which is considered inadequate. As section 65F of the Trade Practices Act 1974 empowers the Minister to order recalls for product correction, the power also applies to recalls for correction which are considered to be inadequate.
At two and six weeks after the implementation of recall, or at other agreed times, the sponsor is to provide the Australian Recalls Co-ordinator with an interim and a final report on the recall. The reports are to contain the following information (however, sponsors are not required to repeat information in the final report that has already been given in the interim report, unless there is a change to that information):
- the circumstances leading to the recall;
- the consequent action taken by the sponsor;
- the extent of distribution of the relevant batch in Australia and overseas;
- the result of the recall - quantity of stock returned, corrected, outstanding, etc;
- confirmation, where practicable, (eg. hospitals, specialist clinicians) that customers have received the recall letter;
- the method of destruction or disposal of recalled goods; and
- the action proposed to be implemented in future to prevent a recurrence of the problem.
These reports establish the effectiveness of the recall and form the basis of reports to the ACCC Product Safety Policy Unit (safety-related recalls) and to the National Co-ordinating Committee on Therapeutic Goods. Unless satisfactory reports are received, further recall action may have to be considered.