Location: De Montil, Essene (Affligem)

Timing: from 13h30 until 17h00

Agenda

Legal Background
- medicinal products - herbal medicinal products (HMP) - traditional herbal
  medicinal products (THMP)
- historical & current milestones in pharmaceutical legislation for (T)HMP
- herbals and the definition of a medicinal product: borderline?

Applications for HMP authorization and THMP registration: what?
- overview procedures
- overview dossier types
- overview dossier requirements
- new possibilities relating to THMP

COFFEE BREAK

Applications for HMP authorization and THMP registration: how?
- orienting the dossier
- preparing the dossier
- evaluation of the dossier

Practical implications of THMP-applications
- dossier requirements in practice
- community monographs/list of entries
- position of the FAMHP
- notification & end of transition period

Round table