European Commission Notice on Significant Benefit

The European Commission has now published its updated Notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products which in particular addresses the concept of “significant benefit”.

  1. Satisfactory method authorised in the Union – Article 3(1)(b) of Regulation 141/2000 requires the sponsor to establish that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the European Union
  2. Re-evaluation of orphan designation criteria at time of marketing authorisation — preauthorisation phase
    1. The new Notice addresses the situation where two MA applications for the same condition are pending with the EMA but where these proceedings not remain in parallel
  3. Designated condition versus authorised indication

The Commission consultation document also discussed the reassessment of the orphan criteria for a new subset of the condition when a sponsor extends the use of its product after marketing authorisation.

The updated notice is available here.

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Published 22. November 2016 in News EU