A patient with a rare medical condition receives approval fr…
A patient with a rare medical condition receives approval from SAHPRA to use an unregistered medicine through a Section 21 application. After several months of treatment, the treating doctor is required to submit a follow-up report to SAHPRA describing the patient’s response to treatment, any side effects experienced, and the overall clinical outcome. Why is it mandatory for the treating practitioner to submit an outcome or progress report to SAHPRA after approval of a Section 21 application?
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