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Further guidance on assessment and management of B12 deficiency is available via NICE Clinical Knowledge Summary (CKS): Anaemia B12 and folate deficiency

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The MHRA ( Medicines and Healthcare products Regulatory Agency ) has two main application procedures: Simple Reclassification : This is a straightforward and quick procedure based on an analogous product (a medicinal product already on the UK market with the same active ingredient, route of administration, use, and a similar or higher strength/dosage)