Based on the legislatively defined sets of "basis for change" documents, changes in the definition of a Medicinal Product - Preparation Production Chain related to the Design Space of the Medicinal Product initiate the following variations that have to be reported to the competent Health Authorities:

• B.II.g.1 Introduction of a new design space or extension of an approved design space for the finished product, concerning:
  

  • a) One or more unit operations in the manufacturing process of the finished product including the resulting in-process controls and/or test procedures

  • b) Test procedures for excipients/intermediates and/or the finished product.

• B.II.g.2 Introduction of a post approval change management protocol related to the finished product

• B.II.g.3 Deletion of an approved change management protocol related to the finished product

• B.II.g.4 Changes to an approved change management protocol

  • a) Major changes to an approved change management protocol

  • b) Minor changes to an approved change management protocol that do not change the strategy defined in the protocol

• B.II.g.5 Implementation of changes foreseen in an approved change management protocol

  • a) The implementation of the change requires no further supportive data

  • b) The implementation of the change requires further supportive data

  • c) Implementation of a change for a biological/immunological medicinal product