CRED Managing Variations Effectively

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

• Addition of a new presentation normally triggers a new EU number. – Introduction of an alternative injection kit with a different number of syringes or swabs, – Introduction of an alternative syringe of different volume or an alternative syringe with a needle guard, – Introduction of an alternative immediate (primary) packaging made from a different material, – Introduction of an alternative shape/dimension of a pharmaceutical form (pre-rolled sealant matrix versus flat, change in size of patch).

Two packs with different contents cannot be covered by the same EU number

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

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