Module 6

04/10/2024

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Responsible self- medication…

• Initial focus… ● “Medicines for the worried well” ✓ Symptomatic treatment of conditions that would otherwise resolve without treatment … and/or that can obviously be safely and easily treated without medical supervision.

The Organisation for Professionals in Regulatory Affairs

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Example - UK Government attitude to OTC Switching

• Continuing to shift … ● RECLASSIFICATION PLATFORM ❑ 2014: Major report on reclassification ❑ ARM: Application for Reclassification of a Medicinal Product ❑ One year data exclusivity for significant test or trial results used for reclassification

https://www.gov.uk/guidance/medicines-reclassify-your-product

The Organisation for Professionals in Regulatory Affairs

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