Annex 21 – Are We On Track And Is There An Impact?

By Geraldine Carr-Mulry, Quality and Regulatory Consultant

Annex 21 details the GMP requirements specified for human, investigational, and/or veterinary medicinal products imported to the European Union and European Economic Area (EEA) by holders of a Manufacturing Import Authorization (MIA). It is possible that the implementation of Annex 21, which aims to establish a robust compliance system, has inadvertently created additional barriers to supply that were not anticipated. Take a deeper look at what Annex 21 entail, what else is involved in the Annex, and what makes the process of meeting these requirements complex and time-consuming.