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Marketing Authorisation of Medicinal Products for Human Use

General

Medicinal products that are to be marketed in Germany fundamentally require official approval for this in the form of a national marketing authorisation or a marketing authorisation from the European Commission.

The competent national agencies in Germany for the granting of marketing authorisations for medicinal products for human use are the Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM).

European marketing authorisations are coordinated by the European Medicines Agency (EMA, London).

Competence of the Paul-Ehrlich-Institut

The PEI is the competent agency for the marketing authorisation of the following medicinal products for human use:

A more precise description of these and other tasks of the PEI may be found in the German list of the PEI’s Official Duties.

The legal basis for the PEI’s activities may essentially be found in the law on the trade in medicinal products (Medicinal Products ActAMG).

Additional legal provisions that are applicable to the marketing authorisation of medicinal products may be found here.

Types of Procedure

Various procedures are available for the marketing authorisation of medicinal products. The type of marketing authorisation procedure to be used depends on the medicinal product itself and whether the pharmaceutical company wishes to market it

  • in Germany alone,
  • in several member states of the European Union (EU) or European Economic Area (EEA) or
  • in the entire European Union (EU) or the entire European Economic Area (EEA).

Medicinal products may be authorised through the following procedures:

All medicinal products that do not fall within the scope of regulation (EC) no. 726/2004, are authorised by the national competent authorities of the EU/EEA member states, either through the national or through the decentralised procedure. Products already authorised in the EU/EEA must be authorised through the mutual recognition procedure. The scientific assessment of the marketing authorisation applications is always performed by the competent national authority (in Germany: the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arnzeimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI)) regardless of the marketing authorisation procedure chosen.

Extensive information on medicinal product legislation at the European level may be found on the website of the European Commission’s Directorate-General for Enterprise and Industry (“EudraLex”).

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Additional Information

Further Information

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