EC: Revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products - annex 16

This Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Economic Area (EEA) of medicinal products for human or veterinary use holding a marketing authorisation or made for export. The principles of this guidance also apply to investigational medicinal products, subject to any difference in the legal provisions and more specific guidance in Annex 13 to the Guide.