GUI PI WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
GUI PI WAN
ARTG
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes
What action should consumers take?
None
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The medicine contains a herbal ingredient (Saussurea costus) which could be confused for Aristolochia species of herbs. Aristolochia herbs contain aristolochic acids, which are not permitted to be present in listed medicines. The sponsor was required to provide testing results to the TGA prior to supply, to demonstrate that their medicine did not contain aristolochic acids, but failed to do so. Subsequent testing indicated that the medicine did not contain aristolochic acids and was therefore unlikely to pose a safety risk to consumers.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an infringement notice (https://www.tga.gov.au/media-release/shen-neng-herbal-medicines-group-pty-ltd-fined-53280-alleged-breaches-therapeutic-goods-legislation) to the sponsor for failing to provide information requested as part of the compliance review.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor provided further information about the medicine and no further action was required.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor provided further information about the medicine and no further action was required.
Additional information
This review was conducted as part of a targeted project