Tech Alert: Fennel – Targeted compliance reviews for required warning statements 

The TGA will be conducting targeted desktop compliance reviews of selected listed medicines that contain fennel. These reviews follow recent signals received by the TGA about the  lack of pregnancy warning statements on products that contain the following ingredients:

 -Foeniculum vulgare (fennel);

 – fennel bitter seed dry;

 – fennel sweet seed dry; and /or

 – fennel oil

This technical alert provides more information for sponsors, including background on historical TGA safety reviews of fennel ingredients.

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