EC: EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use
29.05.2014
Volume 2 of the publications \"The rules governing medicinal products in the European Union\" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements.
The source of the news: http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm
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