Académique Documents
Professionnel Documents
Culture Documents
European Medicine
Strategy and Liver
Diseases/Hepatitis
International Symposium Liver & Drugs 2008 – Viral
Hepatitis – The Health Priority in EU,
September 5, 2008, Bratislava, Slovak Republic
4.CHMP:
Committee for Human Medicinal Products
5.VWP: Vaccine Working Party
The European perspective
= 27 Member States plus
2 observers: Ic & No
The European system – Why?
• Complete single EU market for
pharmaceuticals
• Protect and promote public and animal
health
• Facilitate availability to patients of new
medicines
• Same product information for
professionals and for patients
• Benefit European R&D pharmaceutical
industry
The European system – How?
Management Executive
Board Director
Financial
CHMP CVMP COMP HMPC PedCom
Controller
EMEA Secretariat
Administration Evaluation of Technical Evaluation of
Medicines for Co Medecines for
…… Human Use Ordination Veterinary
Pre- / Post - Use
……. Authorization Inspections
Units …. …….
5/15
Vaccines for preventive use
● Effectivity of vaccines
+
Not reflecting details of the indication wording; * CP = centralised procedure, MRP = Mutual Recognition Procedure;
#
Intron is also approved for use in children and adolescents
Medicinal products for treatment
of Hepatitis (2/2)
http://www.emea.europa.eu/pdfs/human/ewp/3003908en.pdf