CRED Managing Variations Effectively

Type II/IB/IA grouping & WS illustrated – Article 7(b) 

Definition: Licence holder and associated companies

Prior agreement from UK

MAH

MR Procedure Group number

II Amoxicillin EDMF

UK/H/0254/II/049/G

Amoxicillin 125mg/5ml Amoxicillin 250mg caps Amoxicillin 1g IV

IB test procedure FP

IA tighter spec FP

Definition: MA all forms/strengths

Combined MRP WS number

UK/H/0245/01-03 CMS: FR, DE, IT

UK/H/xxxx/WS/011

II Amoxicillin EDMF IB test procedure FP IA tighter spec FP Prior agreement from IE

Co-amoxiclav 125/31 Sus Co-amoxiclav 357mg tab C0amoxiclav 1.2g IV Purely national MA: IE specific reference number

MR and National variations

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