Guideline for Borderline Products

This guideline provides information on the process to be followed when the appropriate regulatory pathway for a specific product is unclear. It also outlines the criteria to be applied to determine whether the product is regulated in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). It should be noted that regulatory decisions relating to borderline products will be made on a case-by-case basis. Applicants are urged to comply with the administrative requirements when submitting applications relating to borderline products to facilitate efficient processing. The South African Health Products Regulatory Authority reserves the right to request additional information where necessary.