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European Medicines Evaluation Agency Products

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... [Pg.279]

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... [Pg.241]

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... [Pg.371]

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... [Pg.237]

European Medicines Evaluation Agency (EMEA) Guideline. Production and Quality Control of Monoclonal Antibodies, Directive 75/318/EEC, 1995. http // www.q-one.com/guidance/emea.htm... [Pg.599]

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). ... [Pg.15]

Major headings should be easily identifiable. The date on which the last version of PI was approved by the State Institute for Drug Control (SUKL) or for centrally registered products by the European Medicines Evaluation Agency (EMEA) must be included. [Pg.164]

European Medicines Evaluation Agency, Committee for Medicinal Products for Human use (CHMP), Efficacy working party, therapeutic subgroup on pharmacokinetics (EWP-PK). Questions Answers on the bioavailability and bioequivalence guideline. Doc. Ref. EMEA/ CHMP/EWP/40326/2006, July 2006. [Pg.38]

The consequences for the scientific assessment of study validity did induce the European Medicines Evaluation Agency and its Committee for Proprietary Medicinal Products (EMEA/CPMP) to issue a draft guideline to deal with this problem of control sample contamination (CPMP, 2004). In this draft guideline reference is made to the GLP Principles and their requirement of fully, and truthfully, representing all results from a study, and the guideline stresses what is required for a GLP-compliant study report as follows The contamination of control samples with the test compound in toxicology studies shall be reported appropriately within a GLP statement as a deviation or violation. Contamination of controls should also be clearly acknowledged in the study reports and discussed by the Study Director with respect to its impact on the validity ofthe study. ... [Pg.19]

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... [Pg.306]

Council Regulation (EEC) No. 2309/93 (see below) stands at the origin of the European Medicines (Evaluation) Agency (EMEA). Established in 1995, EMEA s main task is to coordinate the scientific evaluation of the safety, efficacy and quality of medicinal products which undergo either a Centralized (CP) or Mutual Recognition Procedure (MRP) for authorization. All scientific questions arising in these procedures are dealt with by the EMEA. (A detailed description of how these procedures work is given below). [Pg.1677]


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See also in sourсe #XX -- [ Pg.432 , Pg.434 , Pg.445 , Pg.447 , Pg.454 , Pg.455 , Pg.465 , Pg.559 , Pg.600 ]




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