A manufacturer markets a product containing a pharmacologica…
A manufacturer markets a product containing a pharmacologically active substance listed in the Annexes to the Complementary Medicine guidelines but exceeds the use stipulated for children. The manufacturer claims that because the product is of low risk and has been used in limited settings, it should not require full registration as a medicine for children. When is a product considered registerable as a medicine in South Africa as opposed to listing with a GMP licence?
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