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Licensing

Evaluating medicinal products. Licensing health.

The authorisation of finished medicinal products on the basis of the Medicinal Products Act ("Arzneimittelgesetz", AMG) is one of the main tasks of the BfArM. In the course of these licensing procedures, it reviews the health benefit, i.e. efficacy, safety, and pharmaceutical quality of the medicinal products. Furthermore, the BfArM fulfils important tasks in connection with drug licensing on a European level and thus makes a major contribution towards the prevention of risks to public health.

The BfArM is the authority responsible for licensing medicinal products for humans. Sera, vaccines, allergens, test sera and test antigens, as well as blood products are licensed by the Paul-Ehrlich-Institut; marketing authorisations for medicinal products for use in animals are granted by the Federal Office of Consumer Protection and Food Safety ("Bundesamt für Verbraucherschutz und Lebensmittelsicherheit").
Marketing authorisations of medicinal products are limited to five years. In order for this period to be extended, a corresponding application must be submitted to the BfArM. The medicinal product in question is then again evaluated prior to granting of the renewal. The BfArM must be notified of variations to a medicinal product which has already been granted a marketing authorisation. Substantial amendments can only be made after approval by the BfArM.

Homoeopathic medicinal products are not subject to the same legal requirements as other medicinal products (AMG, Section 38). Most homoeopathic substances do not have to be licensed but are registered. This registration is done by the BfArM.
For further information for healthcare professionals please click "For more information" on the right.

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