The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Documents for Orphan Drug Regulation consultation call
Brief chronology
Existing EU regulation (January 2000) on Orphan Drugs here.
Which was supported by a subsequent regulation in April 2000 “laying down the provisions for implementation of the criteria for designation of medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ here.
A 2003 communication from the Commission was then required to clarify a number of issues including ‘significant benefit’ interpretation here.
Now the Commission is consulting about replacing this communication (a form of guidance) with a new ‘Notice’.
Consultation website here.
Consultation document here (including text of proposed New Notice, and primary issues the Commission seeks view on)
Second draft EAHP response here