Medicinal Products according to Section 2 of the German Medicinal Products Act (Arzneimittelgesetz, AMG)

Medicinal products are substances that are used to treat diseases, to relieve complaints, or to prevent such diseases or complaints in the first place. This definition applies regardless of whether the medicinal product is administered to humans or to animals. The substances can act both within or on the body.

Any substance that is administered in order to enable a medical diagnosis is also considered a medicinal product. One example for this are contrast agents used to make anatomic structures better visible in medical imaging procedures (radiography, magnetic resonance imaging, sonography). The legal definition of medicinal products is laid down in Section 2 of the German Medicinal Products Act (Arzneimittelgesetz, AMG).

It is the purpose of this law to ensure the safety of medicinal products. Therefore, finished medicinal products as defined by the AMG must only be placed on the market if they have been granted a corresponding German or European marketing authorisation, while homoeopathic medicinal products require a German or European registration. Both marketing authorisation and registration of medicinal products belong to the main tasks of the BfArM.

Tasks of the BfArM

However, the BfArM's tasks do not end after a medicinal product has been granted marketing authorisation. At the time of first licensing, the findings on the safety of a medicinal product are not complete. Therefore, experiences with regard to the use of a medicinal product also have to be collected and evaluated consecutively and systematically after granting of the marketing authorisation. This is the most important task of the pharmacovigilance division. If the assessment of the drug risks shows that the licensing status of a medicinal product has to be adjusted to the scientific state of the art, this division will coordinate the necessary measures to avert the danger.