CRED Managing Variations Effectively

Classification of editorial changes

Editorial changes in the SmPC (and corresponding PIL/labelling) updates in line with QRD template, adaptation to excipient guidelines, etc without any impact on the content of the dossier can be included within the scope of another planned IB or type II variation under chapter C that affects the product information. No variation submission is necessary and no reference to a variation code is required.

Q/A List for the submission of variations according to Commission Regulation (EC) 1234/2008 [CMDh/132/2009/Rev. 49 Jan. 2018]

Can be included as part of another variation - not a group fee - Or if no upcoming variation, can be submitted as Type IB C.I.z (see Q&A)

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