The current note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg, EMA/CHMP/BPWP/94033/2007 revision 2) and the core summary of product characteristics (SmPC) for human normal IVIg (CHMP/BPWP/94038/2007 revision 4) have been in operation since December 2000 and underwent a major revision process from 2006 to 2010. The question arises whether the guideline and the core SmPC should be updated to include chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy as being ‘established indications’. Additionally, some international experts recommend that dosing in replacement therapy and in.immunomodulation should be re-evaluated, possibly with adjustment according to lean body weight.