EU MANUFACTURING GUIDELINES

BY KEITH NUTHALL
THE EUROPEAN Commission has released guidelines on dossier requirements for official notifications submitted by European pharmaceutical manufacturers wishing to secure marketing authorisations. The note gives details for handling so called Type 1A and 1B notifications, warning companies to always check that other guidelines are not applicable. * http://pharmacos.eudra.org/F2/eudralex/vol-2/C/GdVarTyplAB_rev0_200307.pdf



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