CRED Managing Variations Effectively

BSV procedure and process:

Type II (standard) National only • Use the most near matched change code • 60 day timeline (unless expedited) and single Type II fee • Expedited: assessment usually completed within 1-2 days – submit request to RIS variationqueries@mhra.gov.uk – evidence of public health interest eg • maintain supply levels for patient • no alternative medicine – confirmation of need from Department of Health (DH) • MAHs obliged to contact DH of potential/actual shortage

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