Licences for Medicinal Products in Germany

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Chapter: Pharmacovigilance: Spontaneous Reporting in Germany

The former EU Directive 75/319/EC was completely implemented into national law in 1978 with regard to the registration and licensing of all medicinal products as defined in that Directive.


LICENCES FOR MEDICINAL PRODUCTS IN GERMANY

The former EU Directive 75/319/EC was completely implemented into national law in 1978 with regard to the registration and licensing of all medicinal products as defined in that Directive. Thus, not only chemically defined medicinal products but also herbal medicines and products used within the homeopathic or anthro-posophic therapeutic medical concept are licensed, if they fit the definition of medicinal products. The same applies to blood products, vaccines and other biologicals. After the complete re-evaluation of old products already on the market in 1978 was finalised by the end of 2005, around 45 370 medicinal prod-ucts are presently licensed in Germany. This figure includes generic products, identical drugs of the same Marketing Authorisation Holder (MAH) and parallel imported drugs. This figure divides into

·    290 centrally authorised medicinal products,2 including vaccines, monoclonal antibodies and biotechnology-derived products in haemotherapy;

·    33 300 chemically defined medicinal products;

·    1150 blood products, vaccines and other biologi-cals;

·    2900 herbal drugs;

·    6650 drugs containing only homeopathic prepara-tions and

·    1120 drugs used in anthroposophic therapy.

 

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