Module 6

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● Can the illness be easily self-diagnosed?

● Is the illness self-limiting?

● What underlying conditions might be masked by self treatment?

● Does the product have a wide safety margin?

● Can the product be used safely without medical supervision?

The Organisation for Professionals in Regulatory Affairs

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● Will the use of the product lead to abuse or mis-use?

● Will the product present a hazard to the community if used unsupervised?

● Is the illness life-threatening?

● Can patients adequate self-monitor and self-treat asymptomatic disease?

● Can management of the condition be enhanced by greater OTC access?

The Organisation for Professionals in Regulatory Affairs

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