European Union Basic Regulation

Since the last edition of this book was published, a plethora of new updating information has become available on the internet. The sheer volume of this is such that it is beyond the reach of this chapter. Attempts to create a standard set of procedures and requirements in the new and enlarged European Union have certainly made progress although the pharmaceutical physician will have to consult the most recent regulations and guidelines if errors are to be avoided. Even such basic concepts as a suspected serious adverse reaction may vary between countries. 

R Mason. Options for the regulation and control of the environmental impact and human health consequences of chemicals in the European Union. In Seiler JP, Vilanova E, eds. Applied Toxicology Approaches Through Basic Science. Berlin Springer Verlag, 1997, pp 113-122. 

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