EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies - Scientific guideline

This document describes the EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies. It discusses how best this requirements can be put into practice.

Keywords: Batch, batch potency, developmental safety and efficacy studies

Current effective version

Guideline on EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies

AdoptedReference Number: EMEA/CVMP/552/02-CONS.