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Implementing Minor Changes is Hard to Do Under Variations Regulation

This article was originally published in The Gold Sheet

Executive Summary

European generic drug makers say that it is difficult to implement Type IA changes under the variations regulation because of all the paperwork involved in submitting these changes to competent authorities. A 26 percent fee hike in filing variations is also making it more costly and difficult for manufacturers to justify making changes.


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Minor Changes Still Burdensome to Report Under Revised Variations Regulation, European Industry and Competent Authorities Complain





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