Based on the legislatively defined sets of "basis for change" documents, changes in the definition of a Marketed Substance related to the Marketed Substance Quality Control Test Procedure initiate the following variations that have to be reported to the competent Health Authorities:

• B.I.b.2 Change in test procedure for active substance or starting material/reagent/intermediate used in the manufacturing process of the active substance

  • a) Minor changes to an approved test procedure

  • b) Deletion of a test procedure for the active substance or a starting material/reagent/intermediate, if an alternative test procedure is already authorized.

  • c) Other changes to a test procedure (including replacement or addition) for a reagent, which does not have a significant effect on the overall quality of the active substance

  • d) Substantial change to or replacement of a biological/immunological/immunochemical test method or a method using a biological reagent for a biological active substance

  • e) Other changes to a test procedure (including replacement or addition) for the active substance or a starting material/intermediate