Information on Medicinal Products
The BfArM provides information on medicinal products for healthcare professionals and consumers. The Public Assessement Reports state the background for scientific evaluations, discussions, and decisions regarding a medicinal product. Product informations containing Package Leaflet and Summary of Product Characteristics which ensure corrrect use of the medicinal product are also published.
Likewise, both the withdrawal of an application for marketing authorisation as well as the refusal of such an application and the reasons that led to this decision have to be published. Decisions of the BfArM on the refusal of a marketing authorisation are published together with the reasoning when the decision is adopted. As long as a decision is not yet legally binding, this circumstance is pointed out.
This reference to the administrative finality in accordance with Section 34 sub-section 1d AMG cannot be immediate on a daily basis as complaints are lodged with the court and the BfArM is only informed of this subsequently. Decisions on withdrawals of applications for marketing authorisation are mady by the company and not by the authority. The BfArM does not receive any information on the reasoning for such a withdrawal and can therefore not publish any. The reference to the administrative finality is also not applicable.
The BfArM also publishes data on shortages in the supply of medicinal products in cases assumed to be of especial interest to healthcare professionals.