CRED Managing Variations Effectively

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Including an Article 61 (3) notification (self cert) within a variation grouping

Tablet 25 mg and Tablet 50 mg (same active substance) Change in shelf life & storage conditions, finished product: • Type IB B.II.f.1. (b)1: shelf life extension  Tablet 50 mg : 36  48 months • Type IB B.II.f.1. (d)1: change storage conditions 25 ° C  none  Tablet 25 mg : 24  48 months

 Tablet 25 mg and Tablet 50 mg • Consequential changes to the label/PIL • Additional non-consequential Article 61(3) 

Notification eligible under self-certification scheme

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