A question arose with the TGA as to whether the ingredient restrictions on the recommended daily dose within the Permissible Ingredients Determination made under Section 26(BB) of the Act ('the Determination') and in some cases, within the Poisons Standard, were applicable to the physical (actual) content of the medicine, or, to the stated (labelled) content. This is important as TGO 101 and other default standard manufacturing tolerances (for example, 90-120%) generally apply to the stated content of the ingredient within the medicine.
The issue arose due to the long-standing understanding of industry that the restriction applies to the stated content of active ingredients. However, the TGA noted the wording in the Permissible Ingredients Determination or the Poisons Standard does not convey that the limits are permitted to be exceeded in manufactured batches of a good in accordance with default quality standards, further, it has not been clarified in published guidance or explanatory information in the instruments that the limits pertain to the stated content of the ingredients, rather than the physical content.
After further correspondence on this issue, CMA are pleased to advise members that the ingredient restrictions in the Determination and Poisons Standard have been confirmed with the TGA to apply to the stated content. Specifically, it has been confirmed by the TGA that it is consistent with the Act for manufacturing tolerances (incorporating stability overages to allow end-of-shelf-life specifications to be met) to apply to ingredients for which limits are prescribed by the Determination and Poisons Standard. That is, the limits in these instruments should be taken to relate to the stated content of an ingredient in a medicine as read in concert with default standards.
While it may be permissible for ingredient limits to be exceeded (in the physical content of the medicine due to permissible manufacturing tolerances) in accordance with default standards, the TGA note that sponsors make a certification when listing a medicine that it is safe for its intended purpose and that this may be asked to be substantiated.
CMA will continue to work with TGA during the year on ways to remove ambiguity of the wording in the Determination and/or the accompanying guidance for listed medicines, to ensure further clarity for industry on the permissible approach to manufacturing tolerances on restricted ingredients.
