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Licensing Procedures

In the course of a licensing procedure, the authority evaluates whether a medicinal product is efficacious and safe and is of the necessary pharmaceutical quality. The corresponding licensing documentation is submitted by the pharmaceutical entrepreneur who wishes to place the medicinal product on the market.

The licensing documentation includes data on analytical, pharmacological-toxicological, and clinical trials as well as the corresponding expert reports. Furthermore, the pharmaceutical entrepreneur has to present the Package Leaflet and Summary of Product Characteristics, labelling texts, and information on the pack sizes. An exact description of the intended pharmacovigilance and risk-management systems is also part of the licensing documentation.

The legal basis for granting a marketing authorisation in Germany is Section 21 sub-section 1 of the Medicinal Products Act ("Arzneimittelgesetz", AMG); Sections 22 to 24 of this Act stipulate the requirements that the licensing documentation must fulfil with regard to content.

If the medicinal product is exclusively intended for marketing in Germany it requires a national licensing procedure.

In order to gain a marketing authorisation for several EU countries at the same time, the pharmaceutical entrepreneur must initiate a so-called Decentralised Procedure (DCP) or submit an application for Mutual Recognition (MRP).

A Centralised Licensing Procedure is necessary in order to receive a marketing authorisation for the entire European Economic Area (EEA). In these procedures, the marketing authorisation for the medicinal product is not granted by a national licensing authority but by the Commission in Brussels. The organisational aspect of such procedures is coordinated by the European Medicines Agency (EMA) in London. The scientific staff of the BfArM as well as that of the other licensing authorities of the Member States of the European Union (EU) are involved in the evaluation of the submitted documentation.

Medicinal products are called "parallel imported medicinal products" if a third party company that is independent of the original marketing authorisation holder or manufacturer purchases them in another Member State of the EU or EEA and imports them to Germany, in order to place them on the market there as well – parallel to the original pharmaceutical entrepreneur. No parallel imported medicinal product may be imported or placed on the German market unless the company has received a corresponding licence by the national competent authority for human medicinal products – i.e., either the BfArM (Federal Institute for Drugs and Medical Devices) or the PEI (Paul-Ehrlich-Institut). Medicinal products that are licensed and marketed outside the EU or EEA cannot be parallel imported.