CARUSO'S Natural Health Pty Ltd has been fined a total of $82,500 by the Therapeutic Goods Administration (TGA) for offences relating to regulatory requirements.
The NSW-based company received five infringement notices for allegedly failing to hold information or evidence to support five therapeutic uses in relation to three medicines.
While sponsors can supply certain low risk listed medicines to consumers without pre-market assessment of efficacy, quality and safety by the TGA, this is dependent on meeting certain regulatory requirements specified in the Therapeutic Goods Act 1989.
Under the Act, sponsors of those listed medicines must, at all times, hold information or evidence that supports each therapeutic use for their medicine, the TGA pointed out.
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