EIGA Technical Bulletin 33/19 –Elemental impurity product risk assessment summary

This Technical Bulletin is intended to be used to prepare the overall elemental impurity product risk assessment summary for Marketing Authorisation Module 3.2.P.5.5 (Characterisation of Impurities) and needs to be adapted for the specific product under consideration.

This publication can be viewed or downloaded on the EIGA Website by clicking here. You can view or download many other EIGA publications at the following address: www.eiga.eu.

29 October 2019

 

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