In the European Union, new pharmaceutical specialities are increasingly not authorised in each individual member state, but simultaneously for all member states via the European Medicines Agency.
The Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) play a central role. Both committees are composed of representatives of the individual member countries and represent the scientific committee of the Commission. The legal basis for the centralised procedure is provided by Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Central authorisation is mandatory for certain drugs, including drugs manufactured using biotechnological processes (e.g. recombinant DNA, monoclonal antibodies, etc.). Not only the manufacture of the medicinal product, but also the therapeutic indication can be decisive for the mandatory centralised marketing authorisation.
- Acquired immunodeficiency syndrome (HIV/AIDS)
- neurodegenerative diseases
- autoimmune diseases and other immune disorders
- viral diseases
Furthermore, central authorisation is mandatory for orphan medicinal products and veterinary medicinal products to increase growth or yield.
Optional centralised authorisation
- New active substances for indications other than those mentioned above if this active substance has not yet been authorised in the EU.
- Significant therapeutic, scientific or technical innovations
- Patient interest (e.g. patient-friendly formulation/administration)
- Generics (e.g. generics of centrally authorised active substances)
In the central procedure, the applicant submits a marketing authorization application to the European Medicines Agency (EMA), which carries out the formal handling of the procedure. The CHMP or CVMP is responsible for the technical assessment of the central applications. The Austrian authority is represented in both committees by experts.
Both committees appoint a rapporteur (rapporteur) and a co-rapporteur (co-rapporteur) for each marketing authorisation application for the central procedure, who play the leading role in the preparation of the scientific assessment report. All CHMP (CVMP) members are involved in the final vote and review of the report.
The Austrian authority has proven expertise in the central authorised procedure and is entrusted with the role of rapporteur or co-rapporteur in the field of biological and biotechnological as well as in the field of chemical drugs.
If the CHMP or CVMP issues a positive opinion, the European Commission in Brussels issues the final notification of authorisation, which is legally binding for all member states of the European Economic Area (27 EU countries + Norway + Iceland + Liechtenstein).