Special situation in Germany: GMP supervision by Bundeslaender Federal States

Germany counts 37 monitoring authorities, including 27 GMP inspectorates which are in charge of monitor manufacturers and importers. There are 6 inspectorates for manufacturers of veterinary vaccines and 10 additional drug examination authorities. According to statistics of the ZLG (only data from 2011 are available), 1,470 inspections were conduct in that year in Germany. Around 2,000 businesses possess a so-called manufacturing and/ or import agreement for medicinal products for human use which therefore means that they manufacture in conformity with the GMP requirements. In such cases, a manufacturing authorization according to § 13 AMG or - for the import - a certificate according to AMG §72a (1)2 is required. Monitoring is analogous to that for therapeutic products.