Therapeutic Goods Order No. 69 - General requirements for labels for medicines (27/08/2001)
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Second schedule
Alternative sources of product literature for disclosure of excipients - prescription medicines
Alternative sources of product literature for partial qualitative disclosure of excipients in medicines included in Schedules 4 and Schedule 8 of the Poison Standard are:
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The ‘Patient Information Document’ also known as ‘Consumer Medicine Information’.
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The current edition of ‘MIMS Annual’, Australian Edition, published by MIMS Australia, division of Medimedia Australia Pty Limited.
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The current edition of ‘Australian Prescription Products Guide’ (‘APP Guide’) published by Australian Pharmaceutical Publishing Company Limited.