Module 12 2019

Change is variation

• Change of information of a manufacturer (i.e. name and/or address), leads to a large number of variations • One supplier supplies multiple companies • Registered in multiple products, type of procedures, different status of Life Cycle of product • Grouping and worksharing possible, but often challenging In eCTD, still a sequence per product is needed • Possible that a change of one manufacturer is not implemented by all MAHs (information not provided to MAH, renewal ongoing, etc) • ISO IDMP can improve this and thus saving a lot of time and money

The Organisation for Professionals in Regulatory Affairs