Centralised procedure

Centralised Procedure of medicinal products

Centralised Procedure of medicinal products
An increasing number of new medicinal products is nowadays centrally authorized at one stroke throughout the EU and not handled by every single member state, as it is the case for e.g. national procedures.
The Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) hold in this regard a central function in this procedure. Both committees consist of representatives of each member state and represent the scientific committee of the Commission. The legal basis for the centralized procedure is laid down in the Regulation (EC) No. 726/2004 of the European Parliament and of the Council.
For certain medicinal products, the centralised authorization is mandatory, e.g.  medicines manufactured by mean of biotechnology processes covering recombinant DNA or monoclonal antibodies. Not only the pharmaceutical technology and manufacture of the drug, but also the therapeutic indication may be relevant with regard to the obligation to apply for a centralized authorization procedure.
Therapeutic areas where centralised procedure is mandatory for marketing authorization applications:
• Acquired immuno-deficiency syndrome (AIDS)Cancer
• Diabetes
• Neurodegenerative diseases
• Autoimmune diseases and other immune dysfunctionsViral diseases
Centralised authorization is also required for Orphan Medicinal Products and for veterinary drugs for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals.Optional centralised authorization:
• New drugs for other than the above indications, if this drug is not yet approved in the EU.
• Significant therapeutic, scientific or technical innovation
• Patient interest (eg, patient-friendly formulation / administration)
• Generic products (eg generics of centrally authorized medicines)
When a company wishes to place on the market a medicinal product that is eligible for the centralised procedure, the application is submitted directly to the European Medicines Agency (EMA). The EMA performs the regulatory affairs of the procedure. The scientific assessment is done by the CHMP or CVMP. The Austrian authority is represented by experts in both committees.
For each new drug application for the centralized procedure the committees define a Rapporteur and a Co-Rapporteur, which take the leading role in the drafting of the scientific assessment report. All CHMP (CVMP) members are involved in the review and final approval of the report.
The Austrian authority has proven expertise in the centralised authorization procedure in the field of biological and biotechnological, as well as in the field of chemical drugs and has already gathered experience as rapporteur as well as co-rapporteur within the last years. In the case of a favourable opinion by the CHMP or CVMP, the European Commission in Brussels takes the final decision which is valid in all Member States of the European Economic Area (the 27 EU countries as well as Norway, Iceland and Liechtenstein).
The European Commission's decision and the European Public Assessment Report (EPAR) are publicly accessible. All centrally authorized products are listed in the Community register.
Web Links:
Centralised Procedure / European Commission
Centralised Procedure / EMA

Created: 19.03.2009 | Page last modified: 15.09.2014

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