In regard to registration of Fiber and Whitening product.
In case of fiber product, we will try to make an application according to Sor.Bor.5, right? (There is a possibility to be rejected by FDA)
If we apply for according to Sor.Bor.5, we do not have to submit safety information as attached, right?
Of course, according to discussion with Ms.Piyanee and Ms.Kannika , they will try to submit Sor.Bor.5 as first.
and when you make an application by Sor.Bor.5, you do not have to make and prepare documents of safety and monitoring assessment.
In case of whitening product, we will make an application according to Sor.Bor.3, right?
If we apply for according to Sor.Bor.3, we have to submit safety information as attached, right?
Of course, the whitening product you must do by Sor.Bor.3 but if in the formulation have beet ceramide is an active ingredient, you must do safety and
monitoring assessment and if the beet ceramide is an inactive ingredient, you do not have to make and prepare documents of safety and monitoring assessment.
If you have any questions please let me know.
In regard to registration of Fiber and Whitening product. In case of fiber product, we will try to make an application according to Sor.Bor.5, right? (There is a possibility to be rejected by FDA)If we apply for according to Sor.Bor.5, we do not have to submit safety information as attached, right?Of course, according to discussion with Ms.Piyanee and Ms.Kannika , they will try to submit Sor.Bor.5 as first.and when you make an application by Sor.Bor.5, you do not have to make and prepare documents of safety and monitoring assessment.In case of whitening product, we will make an application according to Sor.Bor.3, right?If we apply for according to Sor.Bor.3, we have to submit safety information as attached, right?Of course, the whitening product you must do by Sor.Bor.3 but if in the formulation have beet ceramide is an active ingredient, you must do safety and monitoring assessment and if the beet ceramide is an inactive ingredient, you do not have to make and prepare documents of safety and monitoring assessment.If you have any questions please let me know.
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