澳大利亚TGA认证|澳大利亚TGA新广告法对器械包装标识的影响

近期澳大利亚TGA调整了《新医疗产品广告法》过渡期的安排，虽然是对医疗产品广告的处理，但这条法规与我们出口至澳大利亚的产品包装及标签有关联。

2021年1月1日《新医疗产品广告法》取代原《2018医疗产品广告法》并生效。过渡期维持到2022年6月30日，在此期间可遵守2021法规或者2018法规。

与2018法规相比，2021法规中的强制性声明要求做了简化处理，数量也有所减少。

广告商（企业）可以持有符合2018法规强制性声明要求的印刷广告库存，这些库存可以不用完全符合2021法规中的强制性声明。

当这些广告商（企业）用完现有的纸质库存后，TGA 主要采取相对宽松的方法，即，如果时间没有到，可以同时依旧继续使用旧法或2021年《新医疗产品广告法》下的产品包装及标签。

对于可以随时修改的广告，如在线和社交媒体上的广告，TGA期望广告商（企业）在2022年6月30日过渡期结束前，将过渡到2021年《新医疗产品广告法》的要求。

Transitioning to the new Therapeutic Goods Advertising Code

The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements regarding the 2021 Advertising Code, specifically in relation to stock of hard copy ads.

The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Code) came into effect on 1 January 2022. The 2021 Code repeals and replaces the Therapeutic Goods Advertising Code (No.2) 2018 (2018 Code). A transition period applies until 30 June 2022 during which time advertisers can comply with either the 2021 Code or the 2018 Code.

Mandatory statements in advertising

The mandatory statement requirements in the 2021 Code have been simplified and reduced in number compared with the 2018 Code. The TGA recognises however, that advertisers may hold stock of hard copy advertisements that meet the mandatory statement requirements of the 2018 Code but that are not strictly compliant with the 2021 Code.

While advertisers use up their stocks of existing hard copy advertisements the TGA will adopt a pragmatic approach and will not seek to take enforcement action where advertisers comply with the requirements for mandatory statements in the 2018 Code, rather than the 2021 Code.

For advertisements that can be readily amended, such as advertisements online and in social media, the TGA expects advertisers to transition to the 2021 Code requirements by the end of the transition period on 30 June 2022.

往期回顾：澳大利亚医疗器械改革：部分医疗器械的重新分类