Research for infection protection

Authorisation as medicinal product

A distinction is made between medicinal products that require marketing authorisation and those that do not require authorisation. Proprietary medicinal products in accordance to the German Medicines Act (AMG), e.g. Sterillium®, may only be sold when they are authorised by the competent authority. For this, the authority needs to evaluate comprehensive preclinical and clinical documentation and attest a good risk-benefit ratio. For proprietary medicinal product the authorisation needs to be extended after 5 years.