European Union applications

In general, the requirements for registration cire similar to those of the European Union. Applications can be submitted in the European format, providing raw data is removed and a cross reference is made between the Annexures of the MBRl and the relevant data in the European dossier. 

The directive will initially come into force on 29 November 1999. From that date until 28 May 2002 manufacturers have a choice between applying the pressure equipment directive or continuing with the application of the existing national legislation. From 29 May 2002 the pressure equipment directive will be obligatory throughout the European Union. 

The Rules Governing Medicinal Products in the European Union, Volume 2, Notice to Applicants, Medicinal Products for Human Use. http //ec.europa.eu/enterprise/pharmaceuticals/index en.htm. 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... 

Design Aesthetic creation (generally not relevant in the pharmaceutical field) Varies from country to country 25 years in the European Union from application 14 years in the United States from grant... 

There are around 250 chemical entities that have been identified as active components of microbiocidal products in the European Union. The aim ofthis chapter is to introduce the range of chemicals in common use and to indicate their activities and applications. 

The main concern regarding the utilization of Monascus pigments relates to the production of the citrinin mycotoxin in Monascus cultures. Several methods for controlling the mycotoxin production were proposed, including selection of non-toxinogenic strains, control of citrinin biosynthesis, and modifications of culture conditions. Despite their wide and traditional food applications in Asian countries, Monascus pigments have not been approved for use in the United States or European Union. 

National programs are underway to develop and deploy the reactor and applications in China, France, South Korea, and United States [35-38]. Many more countries are participating in R D through the High Temperature Reactor Technology Network of the European Union [39] and the GIF including the 10 member countries [40]. Builds of full-scale commercial demonstration reactors are actively planned in several countries such as South Africa [41] and the United States [38]. 

Lists of field-test notifications in the European Union, the USA, Canada, Australia and Japan respectively. Available from http //engl.jrc/it http //www.nbiap.vt.edu/ http // www.inspection.gc.ca/ http // www.health.gov.au/ogtr/index.htm www. s. affrc.go. jp/docs / sebtan / eguide / edevelp.htm. List of field tests applications for many countries in Asia, South America and Africa are available from http //binas.unido.org/binas/home/ php. 

If adopted by the national authority in question, the sponsor can seek marketing licences in other countries on that basis. For this bilateral phase, other states in which marketing authorization are sought have 60 days in which to review the application. The theory, of course, is that no substantive difficulty should arise at this stage, as all countries are working to the same set of standards as laid down in The Rules Governing Medicinal Products in the European Union . 

INCO-DC, International Cooperation with Developing Countries of the European Union (2001) Sustainable halophyte utilization in the mediterranean and subtropical dry regions. Final Report Jeger MJ (2000) Bottlenecks in IPM. Crop Prot 19 787-792 Kang WS (2001) Development of a flame weeder. Trans ASAE 44 1065-1070 Khasawneh FE, Doll EC (1978) The use of phosphate rock for direct application to soils. Adv Agron 30 159-203... 

The effect of environmental concerns on future developments in the paint industry is discussed. Particular attention is paid to volatile organic compound regulations, developments in powder coatings, and radiation-curable coatings. Tabulated information is presented on applications, backbone type and typical mechanical properties of Incorez W830 series PU dispersions and Incorez W2000 series uiethane/aciylic hybrids. 10 refs. EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... 

There are no occupational exposure limits for many hazardous substances which may require control of inhalation exposures. The necessary data and other resources required for setting such limits is restricted and unlikely to match the potential demand. A hazard categorisation scheme was, therefore, developed for application within the chemical industry. The scheme used readily-available information on toxicological endpoints to place hazardous substances into a limited range of hazard categories, expressed as Occupational Exposure Bands. These Bands could be used as a basis for risk assessment and the selection of appropriate control regimes. 10 refs. EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... 

An examination is made of a European Union directive aimed at limiting emissions of volatile organic compounds arising from the industrial use of organic solvents. Proposed emission limits applicable to the use of solvents in coatings, inks and adhesives manufacture, adhesive bonding and rubber processing are presented. 

At first, any C02-storage project on land falls under the sovereignty of the state in which the project is located. Whereas this simple statement is true for any country worldwide, it has to be kept in mind though, that for cases in Europe the supranational law of the European Union would also be applicable to C02-storage activities in the European Union as well. 

World-wide demand for glycerol is projected to be 0.2 Mt in 2007 and is forecasted to grow by 2.2% per year, driven mainly by personal care and food products [10]. If the target of the European Union directive is achieved, European biodiesel demand could increase to 10 Mt per year by 2010, resulting in 1 Mt of glycerol [2]. The price of glycerol has already fallen by 50% over the past ten years [10, 11]. Thus, the application of glycerol, obtained from the biodiesel process,... 

The 22 papers of the symposium [1] were presented under the headings Theory, Laboratory Studies, Calorimetry (2 sessions), Applications. Several papers are devoted to individual instrumental methods of measuring and assessing potential for exothermic runaway reactions to develop. An issue of the Journal of Loss Prevention in the Process Industries is devoted to a variety of, mostly calorimetric, studies of runaway reactions [2], The proceedings of a European Union Seminar in 1994 appear as a book, including hard data as well as debate about such matters as operator training [3],... 

Similar to the US requirements, there are two regulatory steps to go through before a drug is approved to be marketed in the European Union. These two steps are clinical trial application and marketing authorization application. There are 27 member states in the European Union (as of August 2007) clinical trial applications are approved at the member state level, whereas marketing authorization applications are approved at both the member state or centralized levels. 

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