Appendix B - Product

Information needs to be supplied on the product, especially on efficacy of the product and the physical-chemical properties of the product. For example:

  • study to demonstrate storage stability during the claimed shelf life
  • validated analytical methods for the active substance in the product
  • studies to substantiate efficacy for the prescribed purpose in relation to contact time and concentration.
  • summary of the efficacy studies, in case multiple studies are provided.