Act-No.-36-of-2017-International-Business-Companies-Amendment-Act-2017
商务谈判中的委婉语及其表达方式

商务谈判中的委婉语及其表达方式摘要: 委婉语的使用在商务英语中是一种普遍现象。
它不仅是一种社会语言现象,更是一种文化现象。
文中分析了委婉语与礼貌原则在商务谈判和商务函电中的委婉表达方式,从虚拟语气法、被动语态法、时态倒退法、否定法四个方面归纳分析了商务英语中的委婉表达法,从而使商务工作者“深人字里行间”以求最充分理解和欣赏商务英语的委婉表达方式,从而在商界竞争获取成功。
关键词:委婉语,礼貌原则,商务谈判,委婉表达方式.Abstra ct: Euphem ism expres sionare monlyused in busine ss corres ponde ncesand busine ss negoti ation. whichis not only a social langua ge phenom enon, but it is also a cultur al phenom enon.By making an analys is of euphem istic expres sions and courte sy princi ple used in busine ss corres ponde ncesand busine ss negoti ation s,this papermainly discus ses the fulfil lment of euphem istic expres sions in busine ss Englis h throug h the follow ing four ways: the subjun ctive mood, passiv e voice, tensebackwa rd,negati ve. So the busine ss person nel can fuulyundeer stand and apprec iatethe ephemi sticexpres sionand achiev e a succes s in the petiei ons.Key words:euphemisti c expression; courtesy principle; business negotiation;前言:英语中的委婉语((Euphemism)一词来自希腊语的前缀eu=well和词根phe me=speaking,意思是说好听的话。
租船英语缩写

ABT about大约ABV above以上ACCT accoun t 由...承担,ADV advise通知ADD addres s 地址AFMT afterfix main terms主要条款定下之后AGT agent代理ARBI arbitr ation仲裁AA - Always Afloat经常在海上的AAAA - Always Access ibleAlways Afloat始终保持浮泊并可接近AARA - Amster dam-Antwer p-Rotter dam Area 阿姆斯特丹-安特卫普-鹿特丹地区ADCOM- Addres s Commis sion委托佣金,回扣佣金。
AFSPS- Arriva l FirstSea PilotStatio n (Norway) 到达第一海区引航站(挪威)AFFREI GHTME NT - The hiring of a ship in wholeor part 货(海)运合同,采取整船包运或部分订舱。
AFT - At or toward s the sternor rear of a ship 在船尾,近船尾,向船尾。
AGW - All GoingWell 一切顺利AHL - Austra lianHold Ladder s 澳洲舱梯ANTHAM - Antwer p-Hambur g Range安特卫普汉堡港APS - Arriva l PilotStatio n 抵达引水站ARAG - Amster dam-Rotter dam--Antwer p-GhentRange阿姆斯特丹-鹿特丹-安特卫普-根特港A/S - Alongs ide 靠泊ATDNSH INC - Any Time Day or NightSunday s and Holida ys Includ ed任何时间不分日夜,包括周日和节假日ATUTC- Actual TimesUsed to Count计算用的实际时间BBB before breaki ng bulk 开舱卸货前B/DAYS bankin g days 银行工作日BENDS.BE both ends 指装卸两头(港)BGD bagged袋装的BLK bulk 散装(货)BS/L billsof lading提单BSS 1/1 bases以一个装港一个卸港为基准BWAD bracki sh waterarriva l draft船到卸港的吃水BAF- Bunker Adjust mentFactor. A Fuel Surcha rge expres sed as percen tageaddedor subtra ctedfrom the freigh t amount reflec tingthe moveme nt in the market placepricefor bunker s. 燃油附加费BALLAS T - Heavyweight, oftensea water,necess ary for the stabil ity and safety of a ship whichis not carryi ng cargo.压舱物BAREBO AT CHTR - Barebo at Charte r - Owners leasea specif ic ship and contro l its techni cal manage mentand commer cialoperat ionsonly. 空船租约BDI - Both DatesInclus ive 首尾两天均包括在内BENDS- Both Ends (Load & Discha rge Ports)装卸两港BI - Both Inclus ive xx,xx两者包括在内BIMCO- The Baltic and Intern ation al Mariti me Counci l 波罗的海及国际海事委员会BL (1) - Bale 包装,打包。
CHIMEI KIBISAN SAN PRODUCT GUIDE

CHIMEI KIBISAN® SAN PRODUCT PROPERTY GUIDE
WATER FILTER HOUSINGS
KITCHEN HOUSEWARES
COSMETIC CONTAINERS
TOOTHBRUSH HANDLES
BATHROOM HOUSEWARES
KITCHEN APPLIANCES
MEDICAL DIAGNOSTICS
INSTRUMENT CARRIER RESINS FOR
Tensile Strength at Yield
ISO 527-2/50
MPa
65
65
67
74
79
83
65
65
67
74
Tensile Strength at Break
ISO 527-2/50
MPa
65
65
67
74
79
83
65
65
67
74
Tensile Elongation at Break
ISO 527-2/50
PANEL LENSES
CONCENTRATES
Compared to many other transparent polymers, KIBISAN® offers better chemical resistance, better processability and higher stiffness while maintaining high clarity. Because of its excellent dishwasher resistance, KIBISAN® makes an excellent material choice for housewares that will routinely be cleaned in the dishwasher.
ClinicalInfectiousDiseases

Clinical Infectious Diseases Volume28•Number1January199957Editorial Response:Trains,Travel,and the Tuberclei Checklist for Submitted ManuscriptsMallory D.Wittii List of Abbreviations59Risk Factors for Nosocomial Bloodstream Infections Dueto Acinetobacter baumannii:A Case-Control Study of State-of-the-Art Clinical ArticleAdult Burn PatientsHilmar Wisplinghoff,Walter Perbix,and Harald Seifert 1Cytokines and Chemokines in Meningeal Inflammation:Biology and Clinical Implications67Mayaro Virus Disease:An Emerging Mosquito-Borne Martin G.Ta¨uber and Bernhard MoserZoonosis in Tropical South AmericaRobert B.Tesh,Douglas M.Watts,Kevin L.Russell, 13Photo QuizChitra Damodaran,Carlos Calampa,Cesar Cabezas,Gladys Ramirez,Bruno Vasquez,Curtis G.Hayes,Cynthia A.Rossi,Ann M.Powers,Christine L.Hice, Clinical ArticlesLaura J.Chandler,Bruce C.Cropp,Nick Karabatsos, 14Clinical Experience and Choice of Drug Therapy for John T.Roehrig,and Duane J.Gubler Human Immunodeficiency Virus Disease74Malaria Prophylaxis Using Azithromycin:A Double-Carol L.Brosgart,Thomas F.Mitchell,Blind,Placebo-Controlled Trial in Irian Jaya,Indonesia Rebecca L.Coleman,Toby Dyner,Walter R.J.Taylor,Thomas L.Richie, Kathryn E.Stephenson,and Donald I.AbramsDavid J.Fryauff,Helena Picarima,Colin Ohrt, 23Editorial Response:Time for a New Paradigm—Optimal Douglas Tang,David Braitman,Gerald S.Murphy, Management of Patients with Human Immunodeficiency Hendra Widjaja,Emiliana Tjitra,Asep Ganjar,Virus Infection and AIDS Trevor R.Jones,Hasan Basri,and Josh BermanGregory K.Robbins82Early Mycological Treatment Failure in AIDS-AssociatedCryptococcal Meningitis26Acinetobacter Bacteremia in Hong Kong:ProspectivePhilip A.Robinson,Madeline Bauer, Study and ReviewMary Ann E.Leal,Susan G.Evans,Paul D.Holtom, Hong Siau,Kwok-Yung Yuen,Pak-Leung Ho,DeAnn M.Diamond,John M.Leedom, Samson S.Y.Wong,and Patrick C.Y.Wooand Robert rsen31Editorial Response:Acinetobacter Bacteremia in the93Newly Recognized Focus of La Crosse Encephalitis in TropicsTennesseeHarald SeifertTimothy F.Jones,Allen S.Craig,Roger S.Nasci, 33Legionnaires’Disease on a Cruise Ship Linked to the Lori E.R.Patterson,Paul C.Erwin,Reid R.Gerhardt, Water Supply System:Clinical and Public Health Xilla sery,and William SchaffnerImplications98Assessment of Complement Deficiency in Patients with Maddalena Castellani Pastoris,Renato Lo Monaco,Meningococcal Disease in the Netherlands Paola Goldoni,Bruno Mentore,Giacomo Balestra,Cees A.P.Fijen,Ed J.Kuijper,Marie T.te Bulte, Lorenzo Ciceroni,and Paolo ViscaMohamed R.Daha,and Jacob Dankert 39Editorial Response:Sea,Wind,and Pneumonia106Infective Endocarditis Due to Staphylococcus aureus:59 Paul H.Edelstein and Martin S.CetronProspectively Identified Cases with Follow-up 42U.S.Food and Drug Administration Approval of Vance G.Fowler,Jr.,Linda L.Sanders,Li Kuo Kong, AmBisome(Liposomal Amphotericin B)for Treatment of R.Scott McClelland,Geoffrey S.Gottlieb,Jennifer Li, Visceral Leishmaniasis Thomas Ryan,Daniel J.Sexton,Georges Roussakis, Andrea Meyerhoff Lizzie J.Harrell,and G.Ralph Corey 49Editorial Response:U.S.Food and Drug Administration115Editorial Response:Increasing Importance of Approval of AmBisome(Liposomal Amphotericin B)for Intravascular Device–Associated Staphylococcus aureus Treatment of Visceral Leishmaniasis EndocarditisJonathan D.Berman Chatrchai Watanakunakorn 52A Train Passenger with Pulmonary Tuberculosis:117Obturator Internus Muscle Abscess in Children:Report of Evidence of Limited Transmission During TravelSeven Cases and ReviewMarisa Moore,Sarah E.Valway,Walter Ihle,Rolando M.Viani,Kenneth Bromberg,andand Ida M.OnoratoJohn S.Bradley147Recurrent Ventriculoperitoneal Shunt Infection Due to 123Lymphadenitis Due to Nontuberculous Mycobacteria inChildren:Presentation and Response to Therapy Nontypeable Haemophilus influenzaeRohan Hazra,Caroline D.Robson,Mary E.Lim,Jill A.Hoffman,and Kwang Sik Kim Antonio R.Perez-Atayde,and Robert N.Husson148Herpes Simplex Virus Encephalitis:Chronic ProgressiveCerebral Magnetic Resonance Imaging Abnormalities inPatients Despite Good Clinical Recovery Tuberculosis CommentaryUta K.Meyding-Lamade´,Wolfram made´,130Issues in the Treatment of Active Tuberculosis in Human Brigitte T.Wildemann,Klaus Sartor,and Immunodeficiency Virus–Infected Patients Werner HackeNeil W.Schluger150Endocarditis Due to Fusarium dimerum Four Years AfterCoronary Artery Bypass GraftingAnne-Marie Camin,Christian Michelet,NoteThierry Langanay,Christian de Place,136Successful Short-Term Suppression of Clarithromycin-Sylviane Chevrier,Eveline Gue´ho,and Resistant Mycobacterium avium Complex Bacteremia in Claude GuiguenAIDS151Fatal Group B Streptococcal Meningitis in a Previously Michael P.Dube´,Francesca J.Torriani,Darryl See,Healthy Young AdultDiane V.Havlir,Carol A.Kemper,John M.Leedom,A.J.Barile,A.J.Kallen,and M.R.WallaceJeremiah G.Tilles,J.Allen McCutchan,andFred R.Sattler,for the California Collaborative152Polyradiculitis,Perimyocarditis,and Nephrotic Syndrome: Treatment Group Unusual Manifestations of Infection Due to Listeriamonocytogenes139Answer to Photo QuizC.S.Padovan,M.Liebetrau,A.Danek,W.Scheuerer,and H.-W.Pfister153The Use of Technetium-99m–Labeled White Blood Cell Brief Reports Scan in the Management of a Case of Group AStreptococcus Necrotizing Fasciitis with Polymyositis 140Ehrlichia chaffeensis–Associated Cardiomyopathy in aBonita E.Lee and Joan L.Robinson Patient with AIDSStevan P.Whitt,E.Dale Everett,William Roland,and154Strongyloidiasis and Infection Due to HumanStephen Dolan Immunodeficiency Virus:25Cases at a BrazilianTeaching Hospital,Including Seven Cases of141Spontaneous Recovery from Perinatal Infection Due toHyperinfection SyndromeHepatitis C VirusMarcelo S.Ferreira,Se´rgio de A.Nishioka, Debora Padula,Anna Rodella,Michele Spandrio,Aercio S.Borges,Julia M.Costa-Cruz,Iris R.Rossin, Angelo Rossini,and Elisabetta CarianiAdemir Rocha,M.Tulio A.Silvestre,andF.Regina F.Nunes-Arau´jo142Identification of Shigella boydii in Colonic Malacoplakiaby Universal Bacterial16S Ribosomal DNA–Based155Iatrogenic Meningitis Due to Abiotrophia defectiva After Amplification in a Human Immunodeficiency Virus–MyelographyInfected Patient L.Schlegel,C.Merlet,roche,A.Fre´maux,and Gilles Raguin,Judith Nemeth,Michel Wassef,P.GeslinJean Aerts,Marcelo Salmeron,Nicole Desplaces,156Intravenous Cidofovir-Induced Iritis and Laurent BelecD.Neau,M.B.Renaud-Rougier,J.F.Viallard,143Additional Reports of Failure to Respond to Treatment H.Dutronc,C.Cazorla,J.M.Ragnaud,M.Dupon, After Rabies Exposure in Thailand and cutThiravat Hemachudha,Erawady Mitrabhakdi,157Hematogenous Infection of a Total Hip Prosthesis Due to Henry Wilde,Apirom Vejabhuti,Clostridium perfringensSomporn Siripataravanit,and Darika KingnateH.Ch.Vogely,F.C.Oner,A.Fleer,W.J.A.Dhert, 144Disseminated Nocardia pseudobrasiliensis Infection in a and A.J.VerboutPatient with AIDS in Brazil159Spontaneous Gas Gangrene Due to Clostridium Barbara A.Brown,Jorge O.Lopes,perfringensRebecca W.Wilson,Jane M.Costa,Carla Z.Minutti,Lilly Cheng Immergluck,and Agueda C.de Vargas,Sydney H.Alves,Clovis Klock,Mary Lou SchmidtGrace O.Onyi,and Richard J.Wallace,Jr.160Successful Treatment of Rhinocerebral Zygomycosis:A 145Successful Triple-Antibiotic Therapy for CutaneousCombined-Strategy ApproachInfection Due to Mycobacterium chelonaeton Gaviria,Lisa A.Grohskopf,Robert Barnes, S.Fridolijn Jongevos,Errol P.Prens,andand Richard K.RootJ.M.Werner Habets161Ritonavir,Triglycerides,and Pancreatitis164NoticesR.Clark Perry,Herbert E.Cushing,Mark A.Deeg,and Melvin J.Prince165Statement of Editorial Policy162Myocardial Infarction,Culture-Negative Endocarditis,andChlamydia pneumoniae Infection:A Dilemma?167Checklist of Information for Inclusion in Reports Heinz J.Schaad,Raffaele Malinverni,of Clinical TrialsLee Ann Campbell,and Lukas MatterInstructions to Authors。
Annex 4 Good Manufacturing Practices for pharmaceutical products main principles

© World Health OrganizationWHO Technical Report Series, No. 908, 2003Annex 4Good Manufacturing Practices for pharmaceutical products: main principlesIntroduction37General considerations39 Glossary39Quality management in the drug industry: philosophy and essentialelements451.Quality assurance452.Good manufacturing practices for pharmaceutical products (GMP)473.Sanitation and hygiene484.Qualification and validation48plaints496.Product recalls507.Contract production and analysis51General51The contract giver51The contract accepter52The contract528.Self-inspection and quality audits53Items for self-inspection53Self-inspection team54Frequency of self-inspection54Self-inspection report54Follow-up action54Quality audit54Suppliers’ audits and approval549.Personnel55General55Key personnel5510.Training5911.Personal hygiene5912.Premises60General60Ancillary areas61 36Storage areas61Weighing areas62Production areas62Quality control areas6413.Equipment6414.Materials65General65Starting materials66Packaging materials67Intermediate and bulk products68Finished products68Rejected, recovered, reprocessed and reworked materials68Recalled products68Returned goods69Reagents and culture media69Reference standards69Waste materials70Miscellaneous7015.Documentation70General71Documents required7216.Good practices in production79General80Prevention of cross-contamination and bacterial contaminationduring production80Processing operations81Packaging operations8217.Good practices in quality control84Control of starting materials and intermediate, bulk and finishedproducts85Test requirements86Batch record review87Stability studies88 References88IntroductionThe first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-first World Health Assembly under the title “Draft requirements for good manufacturing practice in the manufacture and quality control of drugs and pharmaceutical specialities” and was accepted.The revised text was discussed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1968 and published37as an annex to its twenty-second report. The text was then reproduced (with some revisions) in 1971 in the Supplement to the second edition of The International Pharmacopoeia.In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the Quality of Pharma-ceutical Products Moving in International Commerce in resolution WHA22.50, it accepted at the same time the GMP text as an integral part of the Scheme. Revised versions of both the Certification Scheme and the GMP text were adopted in 1975 by resolution WHA28.65.Since then, the Certification Scheme has been extended to include the certification of:—veterinary products administered to food-producing animals;—starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting Member State and theimporting Member State;—information on safety and efficacy (resolution WHA41.18, 1988).In 1992, the revised draft requirements for GMP were presented in three parts, of which only Parts One and Two are reproduced in this document (1).“Quality management in the drug industry: philosophy and essential elements”, outlines the general concepts of quality assurance as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspec-tion, personnel, premises, equipment, materials and documentation.“Good practices in production and quality control”, provides guid-ance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of quality assurance.These two parts were subsequently supplemented by further guide-lines which are integral parts of these good manufacturing practices for pharmaceutical products. All these texts are available on the web page of the World Health Organization. (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html)Considerable developments in GMP have taken place in the interven-ing years, and important national and international documents, in-cluding new revisions, have appeared (2, 3, 4, 5). Thus the necessity to revise the main principles and incorporate the concept of validation. 38General considerationsLicensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manu-facturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government drug inspectors, as well as for production, quality control and quality assurance personnel in the industry.The guide is applicable to operations for the manufacture of drugs in their finished dosage forms, including large-scale processes in hospi-tals and the preparation of supplies for use in clinical trials.The good practices outlined below are to be considered general guides1, and they may be adapted to meet individual needs. The equivalence of alternative approaches to quality assurance, however, should be validated. The guide as a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation. A new concept of hazard analysis related to the risks in production and personnel safety is also newly recommeded (Annex 7). The manufac-turer should assure the safety of workers and take the necessary measures to prevent pollution of the external environment. Interna-tional Nonproprietary Names (INNs) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.GlossaryThe definitions given below apply to the terms used in this guide.They may have different meanings in other contexts.active pharmaceutical ingredient (API)Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form.Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.1The word “should” in the text means a strong recommendation.39airlockAn enclosed space with two or more doors, which is interposed be-tween two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment.authorized personThe person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.batch (or lot)A defined quantity of starting material, packaging material, or prod-uct processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the auto-clave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended ho-mogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.batch number (or lot number)A distinctive combination of numbers and/or letters which uniquelyidentifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.batch recordsAll documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.bulk productAny product that has completed all processing stages up to, but not including, final packaging.calibrationThe set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding 40known values of a reference standard. Limits for acceptance of the results of measuring should be established.clean areaAn area with defined environmental control of particulate and micro-bial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.consignment (or delivery)The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch. contaminationThe undesired introduction of impurities of a chemical or microbio-logical nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.critical operationAn operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.cross-contaminationContamination of a starting material, intermediate product or finished product with another starting material or product during production.finished productA finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.in-process controlChecks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.intermediate productPartly processed product that must undergo further manufacturing steps before it becomes a bulk product.41large-volume parenteralsSterile solutions intended for parenteral application with a volume of 100ml or more in one container of the finished dosage form.manufactureAll operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.manufacturerA company that carries out operations such as production, packaging,repackaging, labelling and relabelling of pharmaceuticals.marketing authorization (product licence, registration certificate)A legal document issued by the competent drug regulatory authoritythat establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life.master formulaA document or set of documents specifying the starting materialswith their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.master recordA document or set of documents that serve as a basis for the batchdocumentation (blank batch record).packagingAll operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Filling of a sterile product under aseptic conditions or a product intended to be termi-nally sterilized, would not normally be regarded as part of packaging.packaging materialAny material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.42pharmaceutical productAny material or product intended for human or veterinary use pre-sented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state. productionAll operations involved in the preparation of a pharmaceutical prod-uct, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product.qualificationAction of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning of the word “validation” is sometimes extended to incorporate the concept of qualification.quality assuranceSee Part One (pp. 7–35).quality controlSee Part One (pp. 7–35).quarantineThe status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing. reconciliationA comparison between the theoretical quantity and the actual quantity.recoveryThe introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another batch at a defined stage of manufacture. It includes the removal of impurities from waste to obtain a pure substance or the recovery of used materials for a separate use.reprocessingSubjecting all or part of a batch or lot of an in-process drug, bulk process intermediate (final biological bulk intermediate) or bulk43product of a single batch/lot to a previous step in the validated manu-facturing process due to failure to meet predetermined specifications.Reprocessing procedures are foreseen as occasionally necessary for biological drugs and, in such cases, are validated and pre-approved as part of the marketing authorization.reworkingSubjecting an in-process or bulk process intermediate (final biologi-cal bulk intermediate) or final product of a single batch to an alternate manufacturing process due to a failure to meet predetermined speci-fications. Reworking is an unexpected occurrence and is not pre-approved as part of the marketing authorization.self-contained areaPremises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings.specificationA list of detailed requirements with which the products or materialsused or obtained during manufacture have to conform. They serve asa basis for quality evaluation.standard operating procedure (SOP)An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (e.g.equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection).Certain SOPs may be used to supplement product-specific master and batch production documentation.starting materialAny substance of a defined quality used in the production of a phar-maceutical product, but excluding packaging materials.validationAction of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also qualification).44Quality management in the drug industry: philosophy and essential elements1In the drug industry at large, quality management is usually defined as the aspect of management function that determines and imple-ments the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and autho-rized by top management.The basic elements of quality management are:—an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources;—systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality.The totality of these actions is termed “quality assurance”.Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to gener-ate confidence in the supplier.The concepts of quality assurance, GMP and quality control are inter-related aspects of quality management. They are described here in order to emphasize their relationship and their fundamental impor-tance to the production and control of pharmaceutical products.1.Quality assurance1.1Principle.“Quality assurance” is a wide-ranging concept coveringall matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.1.2The system of quality assurance appropriate to the manufactureof pharmaceutical products should ensure that:(a)pharmaceutical products are designed and developed in away that takes account of the requirements of GMP and other 1Good manufacturing practices for pharmaceutical products, Part One. In: WHO ExpertCommittee on Specifications for Pharmaceutical Preparations. Thirty-second report.Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No.823).45associated codes such as those of good laboratory practice (GLP)1 and good clinical practice (GCP);(b)production and control operations are clearly specified in a writ-ten form and GMP requirements are adopted;(c)managerial responsibilities are clearly specified in job descriptions;(d)arrangements are made for the manufacture, supply and use ofthe correct starting and packaging materials;(e)all necessary controls on starting materials, intermediate prod-ucts, and bulk products and other in-process controls, calibra-tions, and validations are carried out;(f)the finished product is correctly processed and checked, accord-ing to the defined procedures;(g)pharmaceutical products are not sold or supplied before the au-thorized persons (see also sections 9.11 & 9.12) have certified that each production batch has been produced and controlled in ac-cordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products;(h)satisfactory arrangements exist to ensure, as far as possible, thatthe pharmaceutical products are stored by the manufacturer, dis-tributed, and subsequently handled so that quality is maintained throughout their shelf-life;(i)there is a procedure for self-inspection and/or quality audit thatregularly appraises the effectiveness and applicability of the qual-ity assurance system;(j)deviations are reported, investigated and recorded;(k)there is a system for approving changes that may have an impact on product quality;(l)regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consis-tency of the process and ensuring its continuous improvement.1.3The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their in-tended use, comply with the requirements of the marketing authoriza-tion and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibil-ity of senior management and requires the participation and commit-ment of staff in many different departments and at all levels within the 1This is a code governing the testing of chemicals to obtain data on their properties and ensuring safety with respect to human health and the environment. It is different from that described in “Good laboratory practices in governmental drug control laboratories”in the Thirtieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 748, 1987, Annex 1).company, the company’s suppliers, and the distributors. To achieve the quality objective reliably there must be a comprehensively de-signed and correctly implemented system of quality assurance in-corporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of the quality assurance sys-tem should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities.2.Good manufacturing practices for pharmaceutical products(GMP)2.1Good manufacturing practice is that part of quality assurancewhich ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.Such risks are essentially of two types: cross-contamination (in par-ticular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers. Under GMP:(a)all manufacturing processes are clearly defined, systematicallyreviewed in the light of experience, and shown to be capable ofconsistently manufacturing pharmaceutical products of the re-quired quality that comply with their specifications;(b)qualification and validation are performed;(c)all necessary resources are provided, including:(i)appropriately qualified and trained personnel;(ii)adequate premises and space;(iii)suitable equipment and services;(iv)appropriate materials, containers and labels;(v)approved procedures and instructions;(vi)suitable storage and transport;(vii)adequate personnel, laboratories and equipment for in-process controls;(d)instructions and procedures are written in clear and unambiguouslanguage, specifically applicable to the facilities provided;(e)operators are trained to carry out procedures correctly;(f)records are made (manually and/or by recording instruments)during manufacture to show that all the steps required by thedefined procedures and instructions have in fact been taken andthat the quantity and quality of the product are as expected; anysignificant deviations are fully recorded and investigated;(g)records covering manufacture and distribution, which enable thecomplete history of a batch to be traced, are retained in a compre-hensible and accessible form;(h)the proper storage and distribution of the products minimizes anyrisk to their quality;(i) a system is available to recall any batch of product from sale or supply;(j)complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken inrespect of the defective products to prevent recurrence.3.Sanitation and hygiene3.1A high level of sanitation and hygiene should be practised inevery aspect of the manufacture of drug products. The scope of sani-tation and hygiene covers personnel, premises, equipment and appa-ratus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamina-tion to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sani-tation and hygiene. (For personal hygiene see section 11, and for sanitation see section 12, “Premises”.)4.Qualification and validation4.1In accordance with GMP, each pharmaceutical company shouldidentify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled.4.2The key elements of a qualification and validation programme ofa company should be clearly defined and documented in a validationmaster plan.4.3Qualification and validation should establish and provide docu-mentary evidence that:(a)the premises, supporting utilities, equipment and processes havebeen designed in accordance with the requirements for GMP(design qualification or DQ);(b)the premises, supporting utilities and equipment have been builtand installed in compliance with their design specifications (in-stallation qualification or IQ);(c)the premises, supporting utilities and equipment operate in ac-cordance with their design specifications (operational qualifica-tion or OQ);(d)a specific process will consistently produce a product meeting itspredetermined specifications and quality attributes (process vali-dation or PV, also called performance qualification or PQ).4.4Any aspect of operation, including significant changes to thepremises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.4.5Qualification and validation should not be considered as one-offexercises. An on-going programme should follow their first imple-mentation and should be based on an annual review.4.6The commitment to maintain continued validation status shouldbe stated in the relevant company documentation, such as the quality manual or validation master plan.4.7The responsibility of performing validation should be clearlydefined.4.8Validation studies are an essential part of GMP and should beconducted in accordance with predefined and approved protocols.4.9A written report summarizing the results recorded and the con-clusions reached should be prepared and stored.4.10Processes and procedures should be established on the basis ofthe results of the validation performed.4.11It is of critical importance that particular attention is paid to thevalidation of analytical test methods, automated systems and cleaning procedures.plaints5.1Principle. All complaints and other information concerning po-tentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.5.2A person responsible for handling the complaints and decidingthe measures to be taken should be designated, together with suffi-cient supporting staff to assist him or her. If this person is different from the authorized person, the latter should be made aware of any complaint, investigation or recall.5.3There should be written procedures describing the action to betaken, including the need to consider a recall, in the case of a com-plaint concerning a possible product defect.5.4Special attention should be given to establishing whether a com-plaint was caused because of counterfeiting.5.5Any complaint concerning a product defect should be recordedwith all the original details and thoroughly investigated. The person responsible for quality control should normally be involved in the review of such investigations.5.6If a product defect is discovered or suspected in a batch, consid-eration should be given to whether other batches should be checked in order to determine whether they are also affected. In particular,。
新世纪大学英语综合教程4-课后题翻译答案

Unit 11这个村子离边境很近,村民们一直担心会受到敌人的攻击。
(in fear of)2这个国家仅用了20年的时间就发展成了一个先进的工业强国。
(transf orm)3这个公司已经发展成为这个地区主要的化工生产基地之一。
(evolve)4鉴于目前的金融形势,美元进一步贬值 (devalu e) 是不可避免的。
(inevitable)5政府号召市民就控制水污染问题献计献策,但响应却不强烈。
(respon se)6天气没有出现好转的迹象,所以政府号召我们做好防洪的准备。
(show signsof; call upon)7科学家曾一度认为没有比原子更小的东西了,但现在大多数人都知道原子是由更小的粒子(partic le)构成的。
(at one time)8这些同学对世界杯十分关注,每天至少花两个小时看比赛的现场直播。
(be concer ned about; at least)9因为得不到贷款,无法按时开业,这家百货商店损失惨重。
(come by; lose out)10我们不能到那里散步,因为那里有一个海军基地,禁止游客进入。
(off limits)1. The villag e is so closeto the border that the villag ers live in consta nt fear of attack s from the enemy.2. In only twenty yearsthe countr y was transf ormed into an advanc ed indust rialpower.3. This compan y has evolve d into one of the majorchemic al manufa cturi ng basesin this region.4. Giventhe curren t financ ial situat ion, it is inevit ablethat the US dollar will be furthe r devalu ed.5. The govern ment's call for sugges tions aboutthe contro l of waterpollut ion produc ed very little respon se from the citize ns.n mentcalled6. The weathe r showed no signsof gettin g better so the goverr ed for floods.upon us to get prepa7. At one time scient iststhough t that therewas nothin g smalle r thans ts of even smalle r an atom but now most people know that an atom consipartic les.8. The studen ts were all very much concer ned aboutthe WorldCup, spendi ngat leasttwo hourseveryday watchi ng the live matche s on TV.9. The depart mentstorelost out becaus e loanswere very hard to come by and it couldnot startbusine ss on time.s e thereis a navy base there,which10. We can't go therefor a walk becauis off limits to touris ts.Unit 21他的确懂得很多理论,但是,一碰到实际工作就显得非常无知。
肉毒杆菌病的诊断金标准

肉毒杆菌病的诊断金标准英文回答:The gold standard for the diagnosis of botulism is the demonstration of botulinum toxin in clinical specimens orthe isolation of Clostridium botulinum from these specimens.The most common method used to detect botulinum toxinis the mouse bioassay. In this test, a sample from the patient is injected into mice and observed for signs of botulism. If the mice show symptoms of botulism, such as paralysis, then the sample is considered positive for botulinum toxin. This method is highly sensitive and specific, but it is time-consuming and requires the use of live animals.Another method for detecting botulinum toxin is the enzyme-linked immunosorbent assay (ELISA). This test uses antibodies that specifically bind to botulinum toxin to detect its presence in a sample. ELISA is faster than themouse bioassay and does not require the use of live animals, but it may have lower sensitivity and specificity comparedto the mouse bioassay.In addition to detecting botulinum toxin, the diagnosis of botulism also involves the clinical evaluation of the patient. The symptoms of botulism include muscle weakness, difficulty swallowing, blurred vision, and dry mouth. The presence of these symptoms, along with a history of exposure to botulinum toxin, can support the diagnosis of botulism.Furthermore, electromyography (EMG) can be used to confirm the diagnosis of botulism. EMG measures theelectrical activity of muscles and can show acharacteristic pattern of muscle weakness and decreased nerve conduction in patients with botulism.In summary, the gold standard for the diagnosis of botulism is the demonstration of botulinum toxin inclinical specimens or the isolation of Clostridiumbotulinum from these specimens. This can be achievedthrough methods such as the mouse bioassay and ELISA. Clinical evaluation of the patient's symptoms and electromyography can also be used to support the diagnosis.中文回答:肉毒杆菌病的诊断金标准是在临床样本中检测到肉毒杆菌毒素或从这些样本中分离出肉毒杆菌。
Japan Tobacco International 商业用户测试负担减少指南说明书

Who is Japan T obacco International?Japan T obacco International (JTI) is a leading to-bacco product manufacturer, selling its brands in 120 countries. The international division of the company is headquartered in Geneva, Switzerland. JTI employs approximately 40,000 people around the world at 400 offices, 27 fac -tories, five research and development centres, and five tobacco-processing facilities.Reducing the T esting Burden on Business UsersAs a global organisation, JTI relies on its suite of SAP solutions to keep everything runningsmoothly; from finance to Human Resources, and logistics to manufacturing and distribu-tion. T o reduce the overall risk level when new features or versions are introduced, testing is an important part of the software develop-ment lifecycle. JTI traditionally asked the SAP business users to take responsibility for this, as explained by José Jiménez, SAP Delivery Center T est Management Lead within JTI’s IT Global Development Centre: “T esting used to be a manual effort, involving many SAP users on the business side. We used an in-house developed test management tool, along with a record of test plans and results. As our SAP implementation grew, we were very aware that software testing is not a part of our users’ core job and yet we were asking them to spend more and more time on this effort. We could also see that involving so many users in manual testing makes it an error prone activity and we wor-ried about the quality of our software in the long term.”In a bid to increase efficiency and give the users more time for their core jobs, the team looked at outsourcing regression test execu-tion and introducing functional test automa-tion. SAP and Wipro, the chosen outsource partner, weighed in on the technology selec-tion. After extensive market and vendor re-search, the combined team chose the Micro Focus suite of testing tools, licensed through SAP, to support this effort. Micro Focus ALM/Japan T obacco InternationalAchieving ambitious S/4HANA migration with tried and trustedMicro Focus Application Delivery Management solutionsAt a Glance■Industry Manufacturing ■Location Switzerland ■ChallengeReduce the software testing burden on business users, and support a major migration to S/4HANA with huge testing requirements ■Products and ServicesMicro Focus ALM/Quality CenterMicro Focus LoadRunner Professional Micro Focus UFT OneMicro Focus Business Process T esting ■Critical Success Factors+72% test automation drastically reduces burden on business users+98.8% of defects identified and fixed before go-live+Improved test coverage increases software quality+Highly effective combination of regression testing outsourcing and functional test automation +S/4HANA migration involved 2,000 business users, 160,000 tests, and 16,200 defectsCase StudyApplication Delivery Management“We could support a huge-scale project such as the S/4HANAmigration with trusted tools we were already familiar with. Through testing outsourcing and sophisticated automation, we have drasticallyreduced the burden on our business users, improved our test coverage, and increased the quality of our service.”JOSÉ JIMÉNEZSAP Delivery Center T est Management Lead, IT Global Development Centre Japan Tobacco InternationalCase StudyJapan T obacco InternationalQuality Center was implemented as the central test repository, with Micro Focus LoadRunner Professional deployed for performance test-ing, Micro Focus UFT One for functional test-ing, and Micro Focus Business Process T esting (BPT) to accelerate functional test automation. Moving from Business UserT esting to Outsourced and Automated T estingThe new test suite covered all relevant JTI busi-ness processes and even though business users were still key to the success, the new process drastically reduced their time involved. “ALM/Quality Center tracks and manages the entire testing process and defects for us, and we introduced automation for 72 percent of all test cases,” says José. “Business users don’t need to execute the tests themselves any-more, but through an automated process they review and approve the test results before the SAP release go-live. We saw an immediate pro-ductivity improvement with our business users spending 68 percent less time on their testing activities. Over the next couple of years, we refined and automated our testing processes even further, and saw another 65 percent im-provement against the new baseline numbers. This time saving means the users can focus on their core job functions.”The integration between the Micro Focus solu-tions makes it far easier to create test plans, assign testers, set deadlines, execute the au-tomated test scripts, and record the results for each test. Stakeholder feedback was over-whelmingly positive with comments such as: “Great tool!”Smooth S/4HANA Migration—Huge Undertaking Supportedby Micro Focus SolutionsThis level of automation became especially important when JTI made the strategic decision to migrate its SAP environment toSAP S/4HANA, an ERP solution with built-inintelligent technologies, including AI, machinelearning, and advanced analytics. These capa-bilities align with JTI’s ambition to transform itsbusiness and become more agile and flexible.This huge undertaking involved all businessand IT functions within JTI and it would be areal test for the Micro Focus suite of solutions.Micro Focus was able to offer a more flexiblelicence agreement, better suited to the scaleof the SAP S/4HANA testing effort, which led tothe direct partnership between JTI and MicroFocus. The testing project, managed throughALM/Quality Center, involved over 2,000 JTIpeople from all 120 operating countries, tocover all legal entities. In Madrid, the team intro-duced a purpose-built campus facility wheretesters from all over the world worked duringa two-month period. ALM/Quality Center re-corded a peak activity of over 600 concurrentusers, not surprising when you imagine that al-most 160,000 functional tests were executed.User Acceptance T esting (UAT) required themost testers and test runs –however it is es-sential to the success of any major project re-lated to core business systems. Through thetesting process 16,200 defects were reportedwith over 98 percent of them fixed before thenew solution went into production.When asked how the SAP S/4HANA migra-tion might have been managed without thesupport of Micro Focus solutions, José says:“All IT projects within JTI are driven by busi-ness requirements. Moving to S/4HANA hadvery clear benefits and so the migration wouldhave happened, but without the Micro Focussolutions our test coverage would not havebeen as extensive and fewer defects wouldhave been caught before production. T eamswould have managed the testing effort throughspreadsheets and emails which is inherentlyerror prone and higher risk, so we were gratefulthat we already had experience with an inte-grated set of enterprise-ready testing solu-tions to support us. The direct collaborationwith Micro Focus really helped our productivity.We were impressed with the level of supportwe received.”Defining a New RegressionT est Scope with Micro FocusAlmost as soon as the S/4HANA environmentwent live the world was hit with COVID-19, andJTI was forced to change its traditional work-ing practices quite drastically, in line with manycompanies around the world. ALM/QualityCenter and its ecosystem of Micro Focus test-ing solutions enable effective remote teamcolla b or a tion regardless of location and timezones. José was pleased to report that therewas no disruption at all during the pandemic,and in fact, it showcased to management thatthere is a more efficient and agile way of work-ing through o ut the software developmentorganisation.After the successful go-live of S/4HANA, theteam’s attention turned to preparing for the an-nual SAP upgrade process. “S/4HANA is a verydifferent and new environment, so the majorityof our existing test scenarios and processesno longer applied, and we used ALM/QualityCenter to define a new regression test scope,”comments José. “We carefully analysed andselected 5,000 tests that were adapted to workin our S/4HANA environment. The test execu-tion was outsourced, and we worked closelywith Wipro testers in India on a mix of auto-mated and manual test execution. We receivedreports for 170 defects which we visualised ona heatmap we created on top of ALM/QualityCenter with Microsoft Power BI. This was reallyhelpful for us as it clearly showed the urgencyand severity of each defect and its potentialimpact on our users, focusing and prioritisingthe resolution process.”Micro Focus—a T rusted Partnerin High-Profile ProjectsThe annual S/4HANA upgrade is a high-profile exercise that requires C-level approval in each of JTI’s legal entities. Having the clear reporting and analytics in ALM/Quality Center to show the comprehensive testing effort and the re-sults is key. For the first upgrade, 52 different CFOs were presented with independently isolated testing results enabling them to con-fidently provide go-live sign-off for over 100 JTI legal entities.José concludes: “Having worked with the Micro Focus testing toolset for a number of years now has helped us mature our processes and create a very tangible asset for us as an organ-isation. We could support a huge-scale project such as the S/4HANA migration with trusted tools we were already familiar with. Through testing outsourcing and sophisticated automa-tion, we have drastically reduced the burden on our business users, improved our test cover-age, and increased the quality of our service.”“ALM/Quality Center tracks and manages the entire testing process and defect management for us, and we introduced automation for 72 percent of all test cases.”JOSÉ JIMÉNEZSAP Delivery Center T est Management Lead, IT Global Development CentreJapan T obacco International。
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BELIZE:INTERNATIONAL BUSINESS COMPANIES (AMENDMENT)ACT, 2017ARRANGEMENT OF SECTIONS1.Short title.2.Amendment of section 2.3.Amendment of section 5.4.Amendment of section 9.5.Amendment of section 11.6.Amendment of section 12.7.Amendment of section 16.8Amendment of section 31.9.Repeal and replacement of section 34.10.Amendment of section 41.11.Amendment of section 45.12.Amendment of section 49.13.Amendment of section 69.14.Amendment of section 71.15.Insertion of new Part VI A.16.Amendment of section 96.17.Amendment of section 102.18.Amendment of section 103.19Amendment of section 107.20.Amendment of section 108.21.Amendment of section 111.22.Amendment of section 113.23.Repeal and replacement of Part XII.24.Insertion of section 133A.25.Amendment of section 151.26.Transitional.AN ACT to amend the International Business CompaniesAct, Chapter 270 of the Laws of Belize, RevisedEdition 2011; to prohibit the issuance of bearershares in an international business company; toprovide for Register of Directors and Register ofBeneficial Owners and for such Registers to be keptat the registered office in Belize; to provide for theRegisters upon request by the competent authorityto be produced within twenty-four hours; to repealprovisions relating to tax exemptions and providefor the optional payment of income and businesstax by an international business company; and toprovide for matters connected therewith or incidentalthereto.(Gazetted 22nd July, 2017.)1.This Act may be cited as the INTERNATIONAL BUSINESS COMPANIES(AMENDMENT) ACT 2017,Short title.No. 36 of 2017I assent,(SIR COLVILLE N. YOUNG)Governor-General21st July, 2017.and shall be read and construed as one with the International Business Companies Act , which, is hereinafter referred toas the principal Act.2.The principal Act is being amended in section 2(1) to insert the following definitions -a)“Approved Stock Exchange” means the International Stock Exchange of the United Kingdom and the Republic of Ireland Limited (including the Unlisted Security Market of the International Stock Exchange), the New York Stock Exchange, the American Stock Exchange, the National Association of Securities Dealers’ Automated Quotation System of the United States of America or any other stock exchange approved for this purpose by the Minister.b)“beneficial owner” means the natural person–(a)who ultimately owns or controls a customer;(b)on whose behalf a transaction is being conducted; or (c)who exercise ultimate effective control over a legal person or arrangement; and c)“register of beneficial owners” means the register of beneficial owners pursuant to section 82B.d)“ultimately owns or controls” and “ultimate effective control” refer to situations in which ownership or control is exercised through a chain of ownership or by means of control other than direct control.Cap. 270.S.I. 11/2016.S.I. 39/2016.Amendment of section 2.3.The principal Act is amended in section 5(2)(f) by deleting the words “Registration of Merchant Ships Act”and substituting the words “Merchant Ships (Registration) Act”.4.The principal Act is amended in section 9 –(a)in subsection (1)(a)by deleting the words “orshares issued to bearer or both” and substitutingthe word “only.”; and(b)by inserting the following new subsectionsimmediately after subsection (1) –“(1A)Any company that has shares listed forquotation on an Approved StockExchange list may by notice in writingrequire any member of the companywithin such reasonable time as isspecified in the noticeto inform it —(a)whether he holds any voting sharesin the company as beneficial owneror as trustee; and(b)if he hold such voting shares astrustee, to indicate the persons forwhom he holds them by name andby other particulars to enablethose persons to be identified andthe nature of their interest.(1B)Where a company is informed inpursuance of a notice given to anyperson under subsection (1A) or underthis subsection that any other personhas an interest in any of the votingshares in a company, the company may Amendment of section 5. Amendment of section 9.by notice in writing require that other person within such reasonable time as is specified in the noticeto inform it —(a)whether he holds that interest as beneficial owner or as trustee;and (b)if he holds such interest as trustee,to indicate the persons for whom he holds it by name and by other particulars to enable those persons to be identified and the nature of their interest.(1C) Any company to which this section applies may by notice in writing require any member of the company to inform it, within such reasonable time as is specified in the notice, whether any of the voting rights carried by any voting shares in the company held by him are the subject of an agreement or arrangement under which another person is entitled to control his exercise of those rights and, if so, to give particulars of the agreement or arrangement and the parties to it.”1D) A notice under subsection (1A), (1B)or (1C) may be sent either generally to members of the company concerned or to one or more particular members,and may be sent electronically.”.5.The principal Act is amended in section 11–(a)in subsection (1) by deleting the word “Society”and substituting the word “Société”;Amendment of section 11.(b)in subsection (3)(i)by deleting from paragraph (a) the words“except where the company in existencegives its consent”;(ii)by inserting in paragraph (b) immediately after the word “Imperial”, the word“Monarchy”;(iii)by deleting paragraph (d) and substituting the following–“(d)contains any one or more of thewords “Academy”, “AssetManagement”, “Assurance”,“Bank”, “Brokerage”, “CreditUnion”, “Education”, “Fiduciary”,“Financial”, “Foreign Exchange”,“Forex”, “Fund”, “InvestmentManagement”, “Insurance”,“Lending”, “Securities”, “Trust”,or “University” or any of theirderivatives or cognate expressions,unless it is licensed under theenactment or enactments thatauthorize it to carry on the businessor activities associated with theword or words, so contained”;(iv) by inserting after paragraph (d) the following as paragraph (e) –“(e)contains the top level domain suchas “.com”, “.org”, “.net” or “.bz”of a domain name.”(c)by inserting after subsection (3) the followingas subsection (3A) -“(3A)The Registrar may, by Order published in the Gazette , modify the list of words specified in subsection (3)(d ) to which the business or activities of a company may be associated, by, among other things, adding words or abbreviations to the list.”(d)in subsection (5) by inserting after the word,“Gazette ” a comma and the words “the website of the Registrar or other publication of general circulation in Belize.”;(e)by inserting after subsection (8) the following as subsection (9) -“(9)Despite anything contained in this section,an international business company that is continued under this Act –(a)shall be continued with the name it lawfully had before that continuance if there is no other company registered under this Act or the Companies Act in that name; and (b)may only submit to the Registrar a request for the consideration of a change of name after a period of six months has elapsed from the date of continuation pursuant to section 92.6.The principal Act is amended in section 12(1) by deleting paragraphs (i),(j) and (k)and substituting thefollowing –“(i) a statement that the company is prohibited bythis or any other enactment from issuingCAP. 250.Amendment of section 12.bearer shares, and that the company is not authorised to,(a)issue bearer shares;(b)convert registered shares to bearer shares;or(c)exchange registered shares for bearershares;”.7.The principal Act is amended in section 16(2) by inserting immediately after the word “Registrar” where it first appears, the words “along with an authenticated copy of the resolution passed or other authenticated documents, to the satisfaction of the Registrar that the amendment was duly authorised”.8.The principal Act is amended in section 31(1)–(a)in paragraph (c), by inserting after the words,“share register;” the word “and”;(b)in paragraph (d), by deleting the semi colon atthe end of the paragraph and substituting a fullstop;(c)by deleting paragraphs (e) and (f).9.The principal Act is amended by repealing section 34 and substituting the following–“34.A company shall not issue bearer share, convertregistered shares to bearer shares nor exchangeregistered shares for bearer shares, and every companywho contravenes this provision commits an offenceand shall be liable on summary conviction to a fineof $5,000.00 for each day of such failure to comply”.Amendment of section 16. Amendment of section 31.Repeal and replacement of section 34. Bearer shares prohibited.10.The principal Act is amended in section 41–(a)in subsection (1) by deleting the words, “bearer share or the”; and (b)by deleting subsection (2).11.The principal Act is amendment in section 45–(a)in subsection (2) by deleting the words “in the Gazette ” and substituting the words “on the website of the Registrar”;(b)in subsection (4)(c)–(i)after the word “Gazette ” first appearance,insert a comma and the words “the website of the Registrar or other publication of general circulation in Belize”; and (ii)after the word “Gazette ,” second appearance, insert the words “website or other publication,”.(c)in subsection (4)(d), after the word “Gazette ”by inserting a comma and the words “the website of the Registrar or other publication of general circulation in Belize”.12.The principal Act is amended in section 49–(a)in the marginal note by deleting the words“Optional register” and substituting the word “Register”; and(b)by deleting subsection (1) and substituting thefollowing –Amendment ofsection 41.Amendment ofsection 45.Amendment of section 49.“(1)A company incorporated under this Act shall keep a register to be known as aregister of directors containing thefollowing particulars –(a)in the case of an individual director,the individual’s –(i)full name;(ii)former name, if any, unlessthe former name was changedby deed poll or other legalmeans or disused for morethan 10 years;(iii)usual residential address,unless that address is the sameas the individual’s address forthe service of documents;(iv)address for the service ofdocuments;(v)date of birth;(vi)nationality;(vii)occupation;(viii)date of appointment asdirector;and(ix)date of cessation as director(b)in the case of a corporate director,the corporate director’s –(i)corporate name;(ii)corporate or registrationnumber, if any;(iii)registered office or principaloffice;(iv)address, but if the corporatedirector is incorporated orregistered in Belize, itscorporate or registrationnumber only;(v)place of incorporation orregistration and date ofsuchincorporation orregistration;(vi)date of appointment asdirector'(vii)date of cessation as director;and(c)such other information as may beprescribed.”(c)by inserting after subsection 3 the followingas subsections (4) and (5) –“(4)The register of directors is prima facie evidence of any matters directed orauthorised by this Act to be containedtherein.(5) A company thatcontravenes this sectionis liable to a penalty of $25 for each dayor part thereof during which thecontravention continues, and a directorwho knowingly permits thecontravention is liable to a like penalty.”13.The principal Act is amended in section 69–(a)in subsection (1) by deleting the words “depositbearer shares with, or”; and(b)in paragraph(e) by deleting the words, “in thecase of registered shares and the certificates incase of bearer shares”.14.The principal Act is amended in section 71—(a)deleting subsection (1) and substituting thefollowing —“(1) Any notice, information or written statement required under this Act to be given by acompany incorporated under this Act to membersmust be served, in the case of members holdingregistered shares,(a)in the manner prescribed in thememorandum or Articles, as the casemay be; or(b)in the absence of a provision in theMemorandum or Articles, by personalservice of by mail addressed to eachmember at the address shown in theshare register.”; and(b) by deletingsubsections (2) and (3).15.The principal Act is amended by inserting the following as new Part VI A after section 82 –Amendment of section 69. Amendment of section 71.Insertion of new Part VI A.“PART VI ABeneficial Owners 82B. (1) A company incorporated under this Act shall keep a register to be known as the register of beneficialowners containing the following particulars –(a)full name;(b)former name, if any, unless the former namewas changed by deed poll or other legal meansor disused for more than 10 years;(c)date on which the person became a beneficialowner;(d)date on which the person ceasedto be abeneficial owner;(e)usual residential address, unless that address isthe same as the individual’s address for theservice of documents;(f)date of birth;(g)nationality;(h)occupation;(i)particulars of each beneficial owner’s beneficialinterest and how it is held; and(j)such other information as may be prescribed.(2)The directors shall ensure that the information required by subsection (1) to be kept in its register of beneficial owners is accurate and up-to-date.Register ofbeneficial owners.(3)The register of beneficial owners may be in such form as the director may approve but if it is in magnetic, electronic or other date storage form, the company must be able to produce legible evidence of its contents.(4)The register of beneficial owners is prima facie evidence of any matters directed or authorised by this Act to be contained therein.(5)An entry relating to a former beneficial owner of the company may be removed from the register of beneficial owners after 5 years from the date on which that person ceased to be a beneficial owner of the company.(6)A company that contravenes this section is liable to a penalty of $500 for each day or part thereof during which the contravention continues, and a director who knowingly permits the contravention is liable to a like penalty.82C. (1) A beneficial owner of a company incorporated under this Act may, in person or by attorney and in furtherance of a proper purpose, request in writing, specifying the purpose, to inspect during normal business hours the register of beneficial owners of the company and to make copies or extracts therefrom.(2) For the purposes of subsection (1) of this section,a proper purpose is a purpose reasonably related to the beneficial owner’s interest.(3)If a request under subsection (1) of this section is submitted by an attorney, the request must be accompanied by a power of attorney authorising the attorney to act for the beneficial owner.(4)If the company, by a resolution of directors, determines that it is not in the best interest of the company Inspection of register of beneficial owners.or of any other member of the company to comply with a request under subsection (1) of this section, the company may refuse the request.(5)Upon refusal by the company of a request under subsection (1) of this section, the beneficial owner may,before the expiration of a period of 90 days of his receiving notice of the refusal, apply to the court for an order to allow the inspection.82D. (1)If -(a)information that is required to be enteredin the register of beneficial owners undersection 82B (1) of this Act, is omittedtherefrom or inaccurately entered therein;or(b)there is unreasonable delay in entering theinformation in the register of beneficial owners,a beneficial owner of the company, or any person who is aggrieved by the omission, inaccuracy or delay, may apply to the court for an order that the register of beneficial owners be rectified, and the court may either grant or refuse the application, with or without costs to be paid by the applicant, or order the rectification of the register of beneficial owners, and may direct the company to pay all costs of the application and any damages the applicant may have sustained.(2) The court may, in any proceedings under subsection (1) of this section, determine any question relating to the right of a person who is a party to the proceedings to have his name entered in or omitted from the register of beneficial owners, whether the question arises between -Rectificationof register ofbeneficial owners.(a)two or more members or allegedmembers; or(b)between members or allegedmembers and the company, and generally the court may in the proceedings determine any question that may be necessary or expedient to be determined for the rectification of the register of beneficial owners.82E. (1)Subject to subsection (2), a company to which section 82B (1) applies shall identify each beneficial owner of the company.(2)A company to which section 82B applies shall give written notice to anyone whom it knows or has reasonable cause to believe to be a beneficial owner in relation to it, which notice shall require that person –(a)to state whether or not he is a beneficial ownerin relation to the company; and(b)if so, as applicable to provide, confirm orcorrect the registable particulars relating tohim.(3)A company to which section 82B applies shall give written notice to anyone whom it knows or has reasonable cause to believe that such person knows the identity of a person who is a beneficial owner in relation to it, which notice shall require that person –(a)to state whether or not he knows the identityof a beneficial owner in relation to the companyor knows the identity of any person likely tohave that knowledge; and Company’s duty to seek beneficial ownership information.(b)if so, supply any particulars of such persons that are within the knowledge of the person notified.(4)Without limiting subsections (2) and (3), a company may at any time give written notice to a member of the company to provide, confirm or correct the information supplied under section 82B in relation to the shares or guarantee membership interest in the company held by the member.(5)A notice under this section shall state that the person to be notified must comply with the notice within thirty days commencing from the date of the notice.(6)A company is not required to take steps or give notice under this section with respect to a beneficial owner if the company has already been informed in writing of the person’s status as a beneficial owner in relation to it,and has been supplied with the information under section 82B.(7)A company that fails to comply with subsections (2) or (3), commits an offence and is liable on summary conviction to a fine of $50,000.00.82F. (1)Within 30 days of a person becoming a beneficial owner in relation to a company, he shall give written notice to the company of the information requiredpursuant to section 82B.(2)If there is a change in any information provided to the company in relation to a beneficial owner, that beneficial owner shall give written notice to such change to the company and the date on which the change occurred.(3)A person shall not provide false or misleading information under this section.Updating ofbeneficialownership information.(4)A person who contravenes this section commits an offence and is liable on summary conviction to a fine of $50,000.00.”16.The principal Act is amended in section 96(4)(c) after the word “Gazette” by inserting a comma and the words “the website of the Registrar or other publication of general circulation in Belize”.17.The principal Act is amended in section 102–(a)in subsection (4) after the word “Gazette” byinserting the words “ or the website of theRegistrar,”; and(b)in subsection (8) after the word “Gazette” byinserting the words “ or the website of theRegistrar,”.18.The principal Act is amended in section 103(3) after the word “Gazette” by inserting the words “ or the website of the Registrar,”.19.The principal Act is amended in section 107–(a)in subsection (3) after the word “Gazette” byinserting a comma and the words “the websiteof the Registrar or other publication of generalcirculation in Belize”;(b)in subsection (4) by deleting the words “publishin the Gazette” and substituting the words“publish in the website of the Registrar orother publication of general circulation inBelize”.20.The principal Act is amended in section 108(3) by deleting the words, “within 3 years” and substituting “within 5 years”.Amendment of section 96. Amendment of section 102.Amendment of section 103. Amendment of section 107.Amendment of section 108.21.The principal Act is amended in section 111(2)(b)after the word “Gazette ” by inserting the words “ or the website of the Registrar,”.22.The principal Act is amended in section 113 by inserting the following as new paragraphs immediately after paragraph (v) –“(w)$25 upon the approval by the Registrar for publication of a document on the website of the IBC Registry;(x)$25 upon the change of details kept by the Registrar in the register of registered agents.”23.The principal Act is amended by deleting Part XII and substituting the following as new Part XII –“PART XII Income Tax And Other Taxes, Duties And Exchange Control Restrictions 130. (1)An international business company may elect—(a)to be exempted from taxes under the Incomeand Business Tax Act; or(b)to be liable to taxes under the Income andBusiness Tax Act relating to the profits andgains of theinternational business company atthe rate specified in subsection (6).(2)Notwithstanding any provisions of the Income and Business Tax Act an internationalbusiness company that elects to be exempt from tax undersubsection (1)(a)Amendment ofsection 111.Amendment ofsection 113.Repeal andreplacement ofPart XII.Income tax and other taxes.shall not be required to file any tax returns,but an international business company that elects to pay taxunder subsection (1)(b) shall file an annual tax return based on annual financial statements.(3)An international business company shall not be subject towithholding, capital gains or other like taxes except for taxes for an international business company making an election asprovided for in subsection (1)(b).(4)For purposes of this Part, an international business companyshall not be considered to be doing business in Belize solely because it engages in one or more of the activities specified in section 5(2).(5)Notwithstanding, any provision of the Stamp Duty Act to the contrary—(a)an instrument relating to transfers of anyproperty to or byan international businesscompany;(b)an instrument relating to transactions in respectof theshares, debt obligations or other securitiesof aninternational business company; or(c)an instrument relating in any way to the assetsoractivities of an international businesscompany,is exempt from the payment of stamp duty.(6)Pursuant to subsection (1)(b), there shall be levied and paid to the Commissioner of Income Tax, a tax at the rate prescribed by the Minister.CAP. 64. CAP. 55.130A.Any dividend paid or distributedby an international businesscompany, which does no business in Belize, to anotherinternational business company, or to persons, trusts or other entitieswhich are not residents, shall be exempt from any tax or withholdingprovisions of the law in force in Belize which would otherwisebe applicable to the international business company or to the recipientof the dividend or distribution.”24.The principal Act is amended by inserting the following new section 133A immediately after section 133 –“133A. (1) Any registers required to be kept by a company shall be kept at the registered office, and upon a request made by the competent authority, the registered agent shall produce the requested registers within twenty-four hours of the date of receipt of the request.(2) For the purposes of subsection (1)“competent authority” means the International Financial Services Commission established under the International Financial Services Commission Act or other authority so designated, recognized or appointed under an enactment.”25.The principal Act is amended in section 151(2) after the word “Gazette ” by inserting the words “ or the website of the Registrar,”.26.(1)Every company which has issued bearershares shall, within one year from the date of commencementof this Act, convert such shares into registered sharesand cancel all bearer share certificates issued (if any).Exemption fordividends anddistributions.Insertion ofsection 133A.Production of registers.CAP. 272.Amendment ofsection 151.Transitional.(2)Any bearer shares which have not been converted and cancelled within the said period of one year pursuant to subsection (1) shall thereafter be null and void and be without effect for all purposes of law.(3)Where a company which has been in existence prior to the commencement of this Act, fails to comply with section 12(1)(i) within one year from the date of commencement of this Act, as of 1st July 2018 such company shall be deemed to have amended its memorandum in accordance with said section 12(1)(i) and any reference to bearer shares in the company’s memorandum shall be null and void.(4)Every company which has been in existence prior to the commencement of this Act shall, within one year from the date of commencement of this Act, file its register of directors and register of beneficial owners at the registered office.Printed in Belize by the Government Printer。