According to the German Medicines Act (AMG) – also since the 15th Amendment of July17th 2009 – skin antiseptics and hand disinfectants are medicinal products

1. if they can be applied to humans to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action (section 2 para 1 No. 2 AMG, medicinal products by function), or
2. if their designation and/or presentation or the way they are promoted give ordinarily informed persons the impression that these products are suitable for application to humans and for treating, alleviating or preventing diseases or symptoms (section 2 para 1 No.1 AMG, medicinal products by presentation).

Skin antiseptics and hand disinfectants destined for preventing or treating diseases (e.g. hygienic hand disinfection in accordance with the European Standard EN 1500) are to be assessed for pharmaceutical quality, efficacy and safety by the competent authority in regular drug authorisation procedures.

If skin antiseptics and hand disinfectants conform to the AMG definition of medicinal products and to that of the Chemicals Act (Biocides in terms of section 3b ChemG), they are medicinal products according to the “in-case of-doubt-regulation” (section 2 para 3a AMG).

Skin antiseptics and hand disinfectants authorised as medicinal products, continue to be considered as medicinal products (section 2 para 4 AMG).