Medicinal Products Authorised Under Derogation
Medicinal products authorised under derogation are medicinal products that were on the market in the Federal Republic of Germany (or in the former GDR before Germany's reunification) prior to 1978 when the Medicinal Products Act came into force. For such medicinal products the pharmaceutical entrepreneurs had to submit an application for re-evaluation according to the acquis communautaire ("Nachzulassung") if the medicinal product in question was supposed to remain marketable.
In the course of this so-called "Nachzulassung", the BfArM then evaluated such medicinal products with regard to efficacy, safety and pharmaceutical quality. It was the aim of this procedure to re-evaluate all medicinal products on the market according to the same effective European requirements and thus to ensure that patients are adequately supplied with safe and efficacious medicinal products. Until completion of this re-evaluation procedure the medicinal products were considered to be authorised under derogation ("fiktiv zugelassen") and thus continued to be further marketable.
The re-evaluation process was completed on 31 December 2005. For several medicinal products, the necessary proof of efficacy, safety and pharmaceutical quality could not be provided in the course of the re-evaluation process so that the criteria for further marketability were not fulfilled. Marketing authorisation was refused for these medicinal products.
In several cases where the BfArM refused the marketing authorisation, pharmaceutical entrepreneurs lodged an appeal against this decision. In these cases, the medicinal product's authorisation under derogation continues due to the suspensive power of the action until a legally binding court ruling. Therefore, these medicinal products may still be placed on the market and are thus basically available to patients.