English to Serbo-Croat Medical Medical: Pharmaceuticals

1.3 “REGISTRATION DOSSIER”, “DOSSIER” shall mean a document supplied by LICENSOR according to the requirements of the European Union by the date of signature of this Agreement, limited to the Common Technical Documentation (CTD); such document being necessary and useful for the grant of the MARKETING AUTHORIZATIONS for the related PRODUCTS. REGISTRATION DOSSIER shall contain all relevant analytical, technical and galenical data and batch records as well as stability tests, bioequivalence studies and comparative dissolution testing for the TERRITORY, Declaration Letters about Manufacturer, DMF, certificate of TSE freeness according to applicable EU-guidelines and Letter of Access