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Periodic Safety Update Report (PSUR) The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits. 1 September 2015, companies should use the xml delivery file for all […]



The FDA requires a “Stuctured Product Labeling” (SPL) for the registration of medicinal products. UNII Substances Unique Ingredient Identifier – a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. The substances are to be coded by a UNII code. Country Codes SPL represents countries with ISO 3166-1 […]



XEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA) which defines controlled vocabulary to be used for the marketing authorisation of medicinal products. EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development […]