The BSC-based biowaiver procedure is applied to medicinal products in solid dosage forms for systemic action with immediate release for oral use that have the same pharmaceutical form. At the same time, the BSC-based biowaiver procedure is not applied to sublingual, buccal medicinal products and medicinal products with modified release. For medicinal products that disperse in the oral cavity, the BSC-based biowaiver approach may be applied only when absorption in the oral cavity can be excluded.
The biowaiver procedure based on the BCS applies to immediate-release medicinal products if it has been demonstrated that the active substance exhibits high solubility and complete absorption (BCS Class I) and the medicinal product is very rapidly dissolving (> 85 % of the active substance within 15 minutes) or rapidly dissolving (85 % within 30 minutes), or the active substance exhibits high solubility and limited absorption (BCS Class III), and the medicinal product is also very rapidly dissolving (> 85 % within 15 minutes).
