Perth, May 28, 2008 AEST (ABN Newswire) - Stirling Products (ASX: STI) advises that its South African partner, Afgri Limited, has submitted the next stage in the regulatory process towards Act 36 approval.
In a previous announcement (ASX: 24 January), the company reported that in an official correspondence from the South African Medical Control Council (SAMCC), exemption from Schedule 4 of the Medicines and Related Substances Act had been granted for all applications where R-salbutamol is being used as a growth agent, subject to two areas; clarifying the degree of any human impact to the feed additive and the control of potential dust generation.
"Using the subject matter experts in South Africa, our distribution partner Afgri has now submitted an expert report that addresses the potential aspect of any impact on humans," indicated CEO and Managing Director, Dr Calvin London. "We are confident that the report presents a logical argument addressing the concerns about the potential impact of R-salbutamol on users. This is a compound that is used all over the world and is dispensed in several different pharmaceutical forms even at significantly higher dosages without any deleterious effects."
While this is being considered by the SAMCC, the company will prepare and submit a second report to address potential concerns with dust generation thereby satisfying all conditions placed on the approval.
"While we cannot predict what length of time for the reviewers to complete their assessment of the reports, we are one step closer to an approval. On a recent trip to South Africa we discussed some innovative steps to address the dust issue and I am very confident that these steps will not only lead to a better product in South Africa but also provide us with a novel formulation for R-salbutamol products in other jurisdictions.
We look forward to sharing the outcomes of this process with our shareholders," indicated Dr London.
Contact
Dr London
TEL: +61-8-9480-1480
MOB: +61-400-204616
Company website www.stirlingproducts.net
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