A guide to the EU variation procedure from a quality viewpoint

Abstract

This article gives an overview from a regulator’s perspective on the European variation procedure for type IA, type IB and type II variations, including line extensions. Grouping and worksharing processes which should facilitate variation procedures are briefly depicted. Some advice is given on how to avoid unnecessary variation procedures. Four case studies are outlined to illustrate best practice for variation procedures. The fideals with the update of an active substance master fi(ASMF), whereas the second case study illustrates grouping of consequential changes. The third case study reviews sections of Module 3 which should be updated concerning addition of a new supplier of a drug substance which is covered by a certifi cate of suitability (CEP). An example of an unforeseen variation is presented in the fourth case.

Cite this paper

@article{nopitschmai2015guide,
  title = {{A guide to the EU variation procedure from a quality viewpoint}},
  author = {Nopitsch-Mai, Cornelia and Winterscheid, Susanne},
  year = {2015}
}

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