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In order to encourage pharmaceutical companies to invest in orphan drug development, legislation provides for a number of incentives. These include application fee waiver (the extent of reduction varies with the region of the world, and in the European Union it is 50% for all fees since 2002), market exclusivity and protocol assistance. In the European Union, there is 100% reduction in the fee applicable to the provision of any scientific advice. The fund made available by the Community for fee exemptions for orphan medicinal products amounts to= 3 700000 in 2005. [Pg.493]

To provide the NRLs within the European Union and third countries with methods of analysis, technical advice, scientific assistance, and to promote and coordinate research into new methods (65). A series of... [Pg.375]

Occupational Exposure Limits, OELs, are set by the European Union. In 1990, at the request of the Council, the European Commission had set up an informal group of scientists, known as the Scientific Expert Group, SEQ to give advice on setting limit values, after having reviewed the different approaches in the Member States. To encourage the Occupational Exposure Limits, OELs, the European Commission decided to formalize the SEG and with its Decision 95/320/EC of 12 July 1995 has set up a formal base for the work on the scientific evaluation of risk at the workplace related to chemical substances. " The proposed values include ... [Pg.622]


See other pages where European Union scientific advice is mentioned: [Pg.78]    [Pg.78]    [Pg.480]    [Pg.489]    [Pg.370]    [Pg.70]    [Pg.82]    [Pg.83]    [Pg.89]    [Pg.254]    [Pg.405]    [Pg.79]    [Pg.293]    [Pg.285]   
See also in sourсe #XX -- [ Pg.78 ]




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