澳大利亚医药产品召回简介

Brief introduction of recall for therapeutic goods in Australia

简要介绍了澳大利亚医药产品召回的法律法规及其有关体系、定义与目的、程序以及各级部门的职责。医药产品的召回可以由政府或相关产品申报者(包括销售和出口商)实施。召回是针对产品存在的质量、安全性和有效性问题、或因为其他原因需要从供应和使用环节中撤回、或为了进行更正而采取的一种行动。生产企业在医药产品召回中承担着主要责任,政府相关机构则起着协调、监督和检查作用。

This text briefly introduces the laws and the acts of recall for therapeutic goods m Australia,including its system,definition and objective,procedure and responsibility.It is an action taken by authorities and sponsors （including distributors,exporters）when therapeutic goods for reasons relating to their quality,safety and efficacy,or for any other reasons are removed from the links of supply or use,or subject to corrective action.The manufacturers have mainly on their shoulders for the completion of the recall.The authorities take charge of harmony,surveillance and inspection with recall.