CRED Managing Variations Effectively

18 variations for 2 identical products Branded product

Generic duplicate

UK/H/xxx1/001/II/001 complex fee (UK) UK/H/xxx1/001/II/002 complex fee (UK)

UK/H/xxx2/001/II/001 complex fee (UK) UK/H/xxx2/001/II/002 complex fee (UK)

S4.2 update posolgy (duration of treatment Ph III study A07 ) s5.1 update statement regards duration of treatment (Ph III study A07 )

v1 WS

UK/H/xxx1/001/IB/03

UK/H/xxx2/001/IB/003

s4.2 and PIL Section 3 regards timing of dosage

UK/H/xxx1/001/II/004 complex fee (UK)

UK/H/xxx2/001/II/004 complex fee (UK)

s5.1 and PIL (mechanism of action) from Ph III study B03 s5.1 (P’dynamic properties) - Ph III study B03

v2 WS

UK/H/xxx1/001/II/005 complex fee UK/H/xxx2/001/II/005 complex fee UK/H/xxx1/001/II/006 complex fee UK/H/xxx2/001/II/006 complex fee

s5.1 to reflect results of Phase III study B03 s5.1 editorial update (P’dynamics) s4.8 clarify text to enhance readability Update the clinical part of the dossier Total fee for single submission: 12 Type II complex + 6 Type IB Total fee for WS and grouping: 3 Type II complex + 3 Type II standard + 1 Type IB = ½ Type IB

UK/H/xxx1/001/IB/07 UK/H/xxx1/001/IB/008

UK/H/xxx2/001/IB/007 UK/H/xxx2/001/IB/008

v3 WS

UK/H/xxx1/001/II/009 complex fee UK/H/xxx2/001/II/09 complex fee

v4 WS

6 Type II complex + 3 Type IB

6 Type II complex + 3 Type IB

v1 = 1 complex + 1 standard v2 = 1 complex + 1 standard v3 = 1 Type IB + ½ Type IB v4 = 1 complex + 1 standard

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