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

2004 edition

Book pagination

12 April 2017

B. Stages of recall procedure

Recall stage See section
1

Notification to the Co-ordinator Crisis management

This should be to the Australian Recall Co-ordinator.

C
2

Information Required to Assess Recall

Information on product, problem and distribution is required, (see also - The Medicine Problem Report Form, Medical Device Incident Report Form and Human Blood and Tissues Report Form at Appendices I, II and III).

E
3

Assessment of Recall

Liaison between sponsor and Australian Recall Co-ordinator to assess classification, level and strategy of recall.

F
4

Recall

Letters and advertisements are submitted by the sponsor to the Australian Recall Co-ordinator for approval before despatch.

G
5

Notification to the Federal Minister Responsible for Consumer Affairs

Where the recall is safety-related, there is a legal requirement to notify the Minister via the Product Safety Policy Unit, Australian Competition and Consumer Commission (ACCC).

M
6

Progress of Recall and Report

Progress reports are forwarded to the Australian Recall Co-ordinator.

H
7

Follow-up Action

The effectiveness of the recall is monitored by the Australian Recall Co-ordinator.

K

Book pagination