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European Commission: Notice to Applicants, Volume 2C Guidance on Summary of Product Characteristics (SmPC)

24.09.2009
Notice to Applicants, Volume 2C, the guidance document on Summary of Product Characteristics (SmPC) has been updated. It will apply as from 1 May 2010 but submissions in accordance with the updated guidance will also be possible prior to that date.
The source of the news: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/smpc_guideline_rev2.pdf