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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

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EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.