Pharmaceutical Manufacturing License

Any business that commercially manufactures medicinal products in Germany needs a manufacturing license (Herstellungserlaubnis) under Section 13 of the Medicinal Products Act (AMG). This applies to pharmaceutical companies, contract manufacturers, and businesses involved in packaging or labeling of medicines.

You apply to the state authority responsible for pharmaceutical oversight in your Bundesland. The authority inspects your premises, equipment, and processes for compliance with Good Manufacturing Practice (GMP). You must appoint a qualified person (Sachkundige Person) responsible for batch release. Applications should be submitted at least five months before the planned start of manufacturing. The license specifies which product types and manufacturing steps are covered.