CRED Managing Variations Effectively

Type IA Variations – Rejection Rates • Rejections rates fluctuated in the range 10-20% • Increase in rejections linked to specific circumstances

New drug driving offence Specific warning on the SmPC , PIL and label Type IA notification, code C.I.z

New ADR reporting wording Type IA notification, code C.I.z

New variation regulations New codes

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