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Revision of the document “Implementation of policy on elemental impurities in the Certification Procedure”

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Certification of suitability (CEP)
CEP revision
News
19 May 2021
Strasbourg, France

The document of the European Directorate for the Quality of Medicines & HealthCare (EDQM) entitled “Implementation of policy on elemental impurities in the Certification Procedure” has been revised to reflect that risk assessments have to be performed and suitable controls for elemental impurities should be implemented using the principles of risk management for substances for veterinary use. These data must be submitted in CEP applications. This applies to new CEP applications, CEP renewals and requests for revision where changes related to elemental impurities are introduced into the manufacturing process for substances for veterinary use. The title of the document and the template RMS have also been updated.

Its implementation date is the 1 June 2021.

Consult the document Implementation of policy on elemental impurities in the Certification Procedure PA/PH/CEP (16) 23, 2R April 2021

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