Perdays Men's Cleanse & Fertility Support (PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD)
Product Name
Perdays Men's Cleanse & Fertility Support
ARTG
398786
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-2024
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health professional if you have been or are intending on using this medicine to support male fertility
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The name of this medicine made claims regarding supporting male fertility. This claim is not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional when required, which may result in adverse outcomes.
However, current data indicate that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, current data indicate that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine made claims regarding supporting male fertility. However, this claim was not covered by the sponsor's certification that they hold evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issue with this medicine. The sponsor did not sufficiently address the issue. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
The medicine is not eligible for listing (paragraph 30(1A)(a) of the Act).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act).
It appears to the Secretary that the certification under paragraph 26A(2)(a) of the Act is incorrect (paragraph 30(1)(e) of the Act).
It appears to the Secretary that the certification under paragraph 26A(2)(c) of the Act is incorrect (paragraph 30(2)(ba) of the Act).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act).
It appears to the Secretary that the certification under paragraph 26A(2)(a) of the Act is incorrect (paragraph 30(1)(e) of the Act).
It appears to the Secretary that the certification under paragraph 26A(2)(c) of the Act is incorrect (paragraph 30(2)(ba) of the Act).