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Notice given 20 October 2006

2588  Senator Allison: To ask the Minister representing the Minister for Health and Ageing—

(1) Is it the case that the Therapeutic Goods Administration (TGA) has rejected an application for the evaluation, via the over-the-counter route, of a new non-prescription analgesic containing a low dose opioid.

(2) Is it the case that there is a TGA mechanism whereby an applicant can submit a ‘Justification for proposed route of evaluation’; if so, does this justification process apply to medicines in Schedules 4, 8 and 9 of the ‘Standard for the uniform scheduling of drugs and poisons’.

(3) What factors are taken into account in assessing the justification.

(4) Why was this application rejected.