Dr. Andreas Andersen, Anja Hoppenheit, Cornelia Höhne, Dr. Frank Kreutz, Dr. Barbara Steinhoff
Pharmind 11/2015, S. 1593-1602
Life cycle management in general plays an important and increasing role for medicinal products. Adaption to technical progress and simplification of processes require procedural changes that may lead to modification of documentation and variations within the marketing authorisation dossier. For such modifications pragmatic solutions are necessary which take legal requirements as well as feasibility in daily practice and economic aspects into account. Due to their particularities the risk assessment and change management of herbal medicinal products often differ from chemically defined drug products. For this reason proposals for solution are developed which may help to implement the rules for variations within the marketing authorisation dossier for herbal medicinal products in an adequate and reasonable manner. The overall goal is to produce state-of-the art herbal medicinal products and to enable further technical progress in a very strictly regulated area.