European Medicinal Evaluation Agency

Anon., European Medicines Evaluation Agency, Human Medicines Evaluation Unit, Committee for Proprietary Medicinal Products, Points to Consider The assessment of QT interval prolongation by non-cardiovascular medicinal products, CPMP/986/96, London, December 17, 1997, http //www.emea.eu.int/pdfs/human/swp/098696en.pdf... 

Fig. 2 Scheme of the tiered approach of the European Medicines Evaluation Agency (EMEA) for environmental risk assessment... 

EMEA/CHMP - European Medicines Evaluation Agency/Committee for Medicinal Products for Human Use (2006) Doc Ref EMEA/CHMP/SWP/4447/00, guideline on the environmental assessment of medicinal products for human use, 12 pp... 

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... 

Finally, we would like to thank the World Medical Association, The European Medicines Evaluation Agency and the Association of the British Pharmaceutical Industry for permission to reproduce their various documents as appendices to this book. All others who allowed us to quote or use their material are acknowledged in the text, however, a general thanks is appropriate at this point. 

European Medicines Evaluation Agency (EMEA) home page... 

European Medicines Evaluation Agency (EMEA) (2003), Good Manufacturing Practices, Chapter 4 Building and facilities, EMEA. 

Bioavailability According to the European Medicines Evaluation Agency (EMEA), bioavailability (F%) is the rate and extent to which an active moiety is absorbed from a pharmaceutical form, and becomes available in the systemic circulation. As a parameter, there are two types of bioavailability ... 

Combe C, Tredree RL, Schellekens H Biosimilar epoetins an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy (2005) 25(7) 954—962. 

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