European Medicine Evaluation Agency marketing applications

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

Committee on Proprietary Medicinal Products (CPMP) A committee, composed of two people from each EU Member State (see European Union (EU) ), that is responsible for the scientific evaluation and assessment of marketing applications for medicinal products in the EU. The CPMP is the major body involved in the harmonization of pharmaceutical regulations within the EU and receives administrative support from the European Medicines Evaluation Agency. See European Medicines Evaluation Agency (EMEA). ... 

Committee for Proprietary Medicinal Products (CPMP) and European Medicines Evaluation Agency CEM EA) Guidance for industry notes on various aspects of product development and registration in Europe, e.g., Excipients in the dossier for application for marketing authorisation of a medicinal product (111/3196/91) Web sites http //www.eudra.org/ emea/cpmp and http //www.eudra. org/w3/emea.html... 

An application is submitted to the European Medicines Agency (EMEA). The EMEA evaluates the application and forwards its opinion (positive or negative for granting of a marketing authorization) to the European Commis-... 

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