The European Medicines Agency has recently launched a consultation on their Draft guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration.
The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for a human normal immunoglobulin for subcutaneous and/or intramuscular administration.
The deadline for comments for this concept paper is 31 January 2013. The document is available for consultation by clicking here.
Registration No. 1058005