European licensing

In conclusion, a procedure makes it possible to avoid duplication of work not only by manufacturers of raw materials and manufacturers of medicines (finished products) when they prepare licensing dossiers but also by the licensing authorities and pharmacopeia authorities when they assess these dossiers. Differences among the various European licensing authorities in approach and assessment of compliance with European Pharmacopeia monographs are also avoided, and clearer communications are facilitated. Finally, the procedure allows European Pharmacopeia monographs to be constantly updated to keep up with new developments in the world market. 

The institution of the new European licensing systems (centralised and de-centralilsed) in 1995 hcis brought about the most profound change in European pharmaceutical regulation since its inception. The scientific skills and the standards applied have undoubtedly risen, the leveling-off effect hcis been upwards rather than downwards. This is most evident in the new systems where the assessment reports are freely available, but it is edso likely to have affected the national procedures. Skills learned in the centralised procedure will also be applied to national applications. 

There are essentially two types of European licensing procedures ... 

Specifications for hGH products are defined by the governmental licensing authorities, eg, the U.S. Pood and Dmg Administration. Draft monographs for hGH have been prepared by both the EnitedStates Pharmacopia and the European Pharmacopeia commissions and should be formally adopted by 1995. These specifications are suitable for biosynthetic hGH. The much less purified pituitary-derived hGH has virtually disappeared from commercial production. An international reference standard for pituitary-derived hGH (lot 80/505) has been used for caUbration, particularly for bioassay purposes. A highly purified biosynthetic hGH standard (lot 88/624) has been prepared and should be formally adopted by 1995, or before. 

Through Francolor, Farben gained exclusive licenses to 259 foreign patents and 53 patent applications. Some 153 of these were in France, 59 in the United States, and 100 in the other countries of the American, European, and Asiatic worlds. 

Aquatic Life. After Chernobyl, the consumption of freshwater fishes by Europeans declined, fish license sales dropped by 25%, and the sale of fish from radiocesium-contaminated lakes was prohibited (Brittain et al. 1991). Many remedial measures have been attempted to reduce radiocesium loadings in fishes, but none have been effective to date (Hakanson and Andersson 1992). 

BPR [By-Product Recycle] A process for recycling the chlorine-containing by products from the manufacture of vinyl chloride, 1,2-dichloroethane, and other chlorinated hydrocarbons. Combustion with oxygen converts 90 percent of the chlorine to anhydrous hydrogen chloride, and 10 percent to aqueous hydrochloric acid. Developed by BASF and licensed by European Vinyl Corp. 

CC This SWISS-PROT entry is copyright. It is produced through a CC collaboration between the Swiss Institute of Bioinformatics and the CC EMBL outstation - the European Bioinformatics Institute. There are no CC restrictions on its use by non-profit institutions as long as its CC content is in no way modified and this statement is not removed. Usage CC by and for commercial entities requires a license agreement (See CC http //www.isb-sib.ch/announce/ or send an email to CC license isb-sib.ch). 

Gocke E, King MT, Eckhardt K, et al. 1981. Mutagenicity of cosmetics ingredients licensed by the European communities. Mutat Res 90 91-109. 

Establishment Inspection Report Establishment License Application enzyme linked immunosorbent assay European Medicines Agency Environmental Protection Agency European Public Assessment Report end of production cell bank erythropoietin... 

Figure 7 Venomous hymenoptera insects, (a) Common honeybee (Apis me/Z/fera) (b), eastern yellowjacket Vespula maculifrons)-, (c) European hornet (Vespa crabro), (d) bull ant (Myrmecia esuriens)-, (e) Asian giant hornet (Vespa mandarinia japonica,)] (f) wasp stinger. Photos from (a) to (f) by Autan (Creative Commons Attribution ShareAlike License), E. Begin (Creative Commons Attribution ShareAlike License), N. Jones (Creative Commons Attribution ShareAlike License), Nuytsia (Creative Commons Attribution ShareAlike License), Netman (Creative Commons Attribution ShareAlike License), and M. Halldin (GNU free documentation license), respectively.

Eurther to this directive, the European Medicines Agency (EMEA) began, in 2001 [98], to outline a feasible risk assessment scheme, which was later published in a draft form in 2003 [50] in 2006 [51], the following five-step procedure was adopted, with a view to guaranteeing that possible long-term and low-level effects of the new substances are not overlooked this procedure is also used in the licensing of new compounds (including pharmaceuticals). 

Much of the resin reclamation and reprocessing technology comes from overseas, as the Europeans and Japanese have been involved in recycling for a longer period of time. There are other reclamation processes for different resins, which have been developed by or licensed to private companies, but because these are usually proprietary the details of their operations are not known. 

European clinical trial products do not currently require manufacture to GMP however, a new clinical trial directive is undergoing implementation and will necessitate the manufacture to GMP in licensed premises. 

The company has a legal obligation to report all suspected serious ADRs occurring in the European Union to the Licensing Authority within 15 days of the receipt from any health professional. Serious and unexpected suspected ADRs are required to be reported from outside the EU within 15 days of receipt from health professionals. All other ADRs should be reported in the periodic safety updates. 

Ceci A, Felisi M, Catapano M, Baiardi P, Cipollina L, Rav-era S et al. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products. Eur J Clin Pharmaco 2002 58 495-500. 

In 1998, Rochem Group licensed the technology to Pall Corporation (Pall). Prior to 1998, the license for the U.S. Disc Tube market was held by Rochem Environmental, Inc. According to the vendor, the technology has been used successfully in more than 900 European and U.S. petroleum-related applications. Between 1989 and 1995, Disc Tube systems were used to treat landfill leachate at over 30 European landfills. 

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