Research for infection protection

Standardised marketing authorisation

Certain pharmaceuticals or group of pharmaceuticals may be exempted from the obligation of authorisation if their efficacy and safety have been proven. Within the scope of a standard marketing authorisation, certain quality requirements, labelling and authorisation number are specified. Standard marketing authorisations are published in the German Federal Gazette. Manufacturer of pharmaceuticals may produce a medicine in accordance with a standard marketing authorisation without applying for an individual approval. The Federal Institute for Drugs and Medical Devices (BfArM) need to be notified only if it is a pharmacy-only medicine. For hand, skin and mucous membrane disinfection, there are standard marketing authorisations with alcohols, iodine and hydrogen peroxide.
The formulas of standard marketing authorisations contain only as much ingredients as necessary (e.g. in terms of efficacy) and as little ingredients as possible (e.g. in term of nourishing substances).