Therapeutic Goods Order No. 69 - General requirements for labels for medicines (27/08/2001)
7Permitted statements of storage conditions
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7 Permitted statements of storage conditions
7(1) For the purposes of subclause 3(2):
(a) the following statements of storage conditions are permitted -
(i) ‘Store below -18oC (Deep freeze)’;
(ii) ‘Store below -5oC (Freeze)’;
(iii) ‘Store below 8oC (Refrigerate)’;
(iv) ‘Store at 2oC to 8oC (Refrigerate. Do not freeze)’;
(v) ‘Store below 25oC’; and
(vi) ‘Store below 30oC’;
(b) if none of the statements of storage conditions included in subclauses 7(a)(i) to (vi) inclusive are applicable, the sponsor must apply to the Secretary for permission to use an alternative statement; and
(c) a statement of storage conditions specifying a maximum temperature in excess of 30oC may be permitted on application to the Secretary, subject to the review of data to establish the stability of the goods at the higher temperature.