Marketing Authorisation of Medicinal Products for Human Use
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:
- blood products (blood components for transfusions, plasma derived products, recombinant preparations)
- gene transfer medicinal products
- tissue preparations
- immunoglobulin preparations
- bone marrow preparations
- monoclonal antibodies
- sera from donor animals
- tuberculins and other medicinal products
- cell therapeutics (somatic and xenogenic)
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 Act – AMG).
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:
- national procedure
European marketing authorisation procedures:
- centralised procedure
- mutual recognition procedure (MR procedure)
- decentralised procedure: For the marketing authorisation of medicinal products containing a new active substance and for the treatment of a particularly serious disease, the Centralised European marketing authorisation is absolutely required. The marketing authorisation is granted by the European Commission. The groups of medicinal products concerned are listed in the Annex of the European Regulation (EC) No. 726/2004. Optionally, such medicinal products may the authorised using the centralised marketing procedure if it constitutes an innovation and/or if it is in the interest of public health to market the medicinal product in the whole of Europe (cf. Article 3 (2) of Regulation (EC) No. 726/2004.
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”).