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Search AusPARs. Before a prescription medicine can be made available in Australia, the company legally responsible for supplying the product must lodge a submission with the TGA. The TGA then evaluates the safety, quality and effectiveness of the product https://quizlet.com to determine if the benefits to people taking the medicine outweigh the risks. If a company wants to change something about the medicine once it is available, they also need to lodge a submission for the TGA to evaluate. A new transparency initiative with regards to new prescription medicine decisions will take effect from 1 September This initiative is subject to ongoing assessment. The AusPAR document includes a summary of the clinical findings, while the Extract from the Clinical Evaluation Report provides more detail about the clinical assessment.
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