Help finding German Regulation/Law

Kaider, Brian BKaider at HEWM.com
Fri Sep 4 11:25:29 EST 1998


Hello,

I am hoping someone can help me with something.  I am writing from a law
firm in Washington DC.  We have a client who manufactures a monoclonal
antibody and send it to their facility in Germany, as part of a world-wide
investigational trial.  Recently, the German office of this company sent our
client a letter stating that "under German law," they are required to
re-test the antibody when it arrives in Germany, even though it has already
been tested in the US.  Our client wants to know exactly what needs to be
done.

My questions are:  What is this law? Where can I find it?  Is there a place
that I can see it, written in English?

Any advice or help you could give me would be greatly appreciated.

Sincerely,

Brian D. Kaider
Legal Assistant

Please respond via email to:  bkaider at hewm.com





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