tailieunhanh - Definition of Non Investigational Medicinal Products (NIMPs)

Because agricultural production is seasonal, the products have to be stored for distribution later. The storage function involves risks -- risks of deterioration of products and risks of fluctuating market prices. Elaborate precautions are taken to guard against any deterioration of products from excessive moisture, heat, contaminating metals, bacteria and fungi, insects, and rodents and against loss from fire and theft. Whether a stored commodity is held by a farmer, a warehouseman, a processor, a wholesaler, or a retailer, the risk of a drop in the market price is always present. Various devices are used to shift the. | EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Definition of Investigational Medicinal Products IMPs Definition of Non Investigational Medicinal Products NIMPs To be included in The rules governing medicinal products in the European Union Volume 10 Clinical Trials Notice to Applicants Chapter V Additional Information Questions and Answers Investigational Medicinal Product IMP Introduction To facilitate clinical trials in the case of multi-centre trials carried out in more than one Member States it is necessary to have a common understanding of the definition of an investigational medicinal product. This document presents a definition of investigational medicinal products and non-investigational medicinal products as agreed between the Member States and the Commission. The definition of an investigational medicinal product IMP is linked to a the definition of a medicinal product b the intended use of a medicinal product and c the definition of a clinical trial for the purposes of Directive 2001 20 EC1. A clear understanding of the definition of an IMP requires knowledge of the definitions of a medicinal product and of a clinical trial these two definitions are provided in Annex A. An algorithm and its endnotes provided in the Notice to applicants Questions and Answers Clinical Trial Documents2 3 will help sponsors to determine whether the study is a clinical trial on medicinal product or not. Directive 2001 20 EC Article 2 d provides the following definition for an IMP a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial including products already with a marketing authorization but used or assembled formulated or packaged in a way different from the authorised form or when used for an unauthorised indication or when used to gain further information about the authorised form. Therefore to classify a medicinal product as an investigational medicinal product a .