CRED Managing Variations Effectively

Changes in presentations: When do I need a new EU number?

• Any changes in the number of units of medicinal product / integral medical device trigger a new EU number

• Replacement of a presentation does not normally trigger a new EU number (e.g. replacement of primary/secondary packaging, number of non integral devices, changes in composition)

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations

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