definiens: means a description of the Product, its manufacture, its Specification and other information relevant to its production by Sterling including such information about Sterling and Sterling 's production operation as is relevant to satisfy regulatory authorities as to the fitness of the Product as manufactured by Sterling for use of the Product in human and veterinary medicine . A European Drug Master File will comprise an and a or other designations with the same meanings . means that Information contained within a regulatory submission which is in principle accessible by the public . means that Information contained within a regulatory submission which is not available for public disclosure or use and shall include but not be limited to a description of the manufacturing process, Product specification and methods of analysis, raw materials and intermediates and their specifications and methods of analysis, a description of possible impurities, stability test data and packaging and labelling . The Information contained in the Open Part and the Closed Part of a European Drug Master < PAGE > Page 3 of 22 File or any other Drug Master File the format of which includes a Closed Part or confidential section, shall be authorised by Stegram