CRED Managing Variations Effectively

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Presubmission information • list of MAs

Letter of intent for WS • MAH submits to CMDh secretariat min. 6 weeks before planned submission

CMDh secretariat • receives letter of intent •presubmission information

• justification for MAHs • scope of change(s) • preferred Ref Auth wrt granted MAs

• suitability for WS • submission date

CMDh informs MAH • acceptance • confirms Ref Auth • suitability for WS

CMD member of Ref Auth • receives letter of intent • presubmission information

2 weeks

CMDh • discussion and advice if requested

CMDh possible • discussion – CMD/WG • referral

MAH • requests WS procedure No. • submit varn to Ref Auth/CMS – one common form and letter

Ref Auth • validation • start assessment • Type II timeline (60 days)

Ref Auth • final opinion

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