New regulations for API manufacturing in Germany "AMWHV"

Based on the EU Directive 2004/27/EC, amending directive 2001/83/EC, which requires for that all medicine APIs must be manufactured according to the GMP guidelines as defined by ICH-Q7A, Germany's health agency published the 14. AMG-Novelle (14th amendment of the law) on Sep. 06, 2005. Concurrently to this update the agency revised the Pharmabetriebsverordnung (PharmBetrV), that regulates manufacture and control of pharmaceuticals. The revised version of the PharmBetrV is now called AMWHV, ArzneiMittel- und WirkstoffHerstellungsVerordnung (regulation for the manufacturing of pharmaceuticals and APIs). The AMWHV is effective since November, 10, 2006