Re-scheduling / Re-classification Services - Project Examples

First-in-class Switch from Prescription to OTC

Capital K was commissioned by the local affiliate of a major pharmaceutical company to plan, manage and submit an Australian rescheduling application for a prescription product. The application represented the first attempt at rescheduling this therapeutic area in Australia and the first attempt for the medicine worldwide. Engagement was required with a wide range of medical, pharmacy and patient stakeholder groups, an algorithm to be implemented in pharmacy was developed, and supporting training and education materials for healthcare professionals and consumers were drafted to support the overall application, with excellent feedback received from all stakeholders.


Rescheduling from OTC to Free-Sale

Capital K was engaged by the local affiliate of a major pharmaceutical company to provide strategic and operational support for a second attempt submission to allow sales of a first-in-class Australian medicine in grocery. Capital K's strategic direction was pivotal in developing suitable grocery labelling, and the application under Capital K's guidance received a positive recommendation by the ACSOM.


Broad Review of Reclassification Opportunities

Capital K was appointed by an international consulting firm to provide insight into the most likely medicines to be granted recommendations for down-scheduling in the Australian and New Zealand markets. The project involved a critical appraisal of current prescription medicine classes for switch feasibility, comparison of pharmacological classes and individual molecules within the classes, and potential opportunities to further down-schedule existing OTC classes. The project involved evaluating the feasibility for local market translation of international precedents and also identification of particular challenges and data gaps for re-scheduling to be successful. Capital K's insight was a significant influence in the consulting firm's global report conclusions.


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Re-scheduling / Re-classification Services