Module 12 2019

M2-5 Granularity

• ICH document that defines the granularity for the Modules 2 to 5. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/ M4_R4_Organisation/M4_R4__Granularity_Document.pdf • Once a particular approach has been adopted, the same approach should be used throughout the life of the dossier since it is the intention that replacement documents/files be provided when information is changed

The Organisation for Professionals in Regulatory Affairs

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