Bundled Variations

What is the procedure for changes to the finished product manufacturer if several new quality control sites and several deletions and/or name changes are to be applied for in a bundle?

As an alternative to submitting several variations for notifications . a variation subject to approval for a Quality Manufacturer Finished Product (EU B.II.b.1) may be submitted with all notifications No.13 (new or additional production site for the primary, secondary packaging or repacking of a ready-to-use medicinal product) and notification No.15 (deletion of a production site). It is likewise possible to submit a variation subject to approval for a Quality Manufacturer Finished Product (EU B.II.b.2) with all  notifications No.14 (new/additional test laboratory for quality control or new/additional manufacturer responsible for batch release of the ready-to-use medicinal product or active substance) and notification No.15. A notification No.11 (change of name or domicile of a manufacturer of ready-to-use medicinal products) must be submitted separately.

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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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