Natural Micronised Progesterone exemption applied to a product with excipients where its essential character remained unchanged.

The exemption for Natural Micronised Progesterone was held to extend to a product marketed as "Sugest" despite the presence of added excipients, because the essential character of the medicine remained unchanged and it continued to match the exempted entry in substance. The inclusion of other ingredients was treated as consistent with manufacture of a medicine from the base drug, and not as a reason to deny the benefit of the notification. On that basis, the product was treated as eligible for exemption under the relevant notifications.

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Issues: Whether the product marketed as "Sugest", containing Natural Micronised Progesterone with added excipients, remained covered by the exemption for Natural Micronised Progesterone under the relevant notifications.

Analysis: The exemption entry covered the drug and medicine identified as Natural Micronised Progesterone. The addition of excipients did not change the basic character of the medicine where the product continued to be sold as Natural Micronised Progesterone and matched the exempted entry in substance. The product's composition with other ingredients was treated as consistent with manufacture of a medicine from the basic drug and not as a ground to deny exemption.

Conclusion: The product was held eligible for exemption under the notifications.

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