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EUCOPE comments on the Draft Notice on Significant Benefit for Orphan Medicinal Products

3. March 2016 in News Newsletter Press Releases

On 15 February, EUCOPE has submitted its comments on the Draft Commission Notice on the Application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on Orphan Medicinal Products (OMPs) defining and explaining the criteria that lead to an OMP designation.

Given that these guidelines have remained unchanged for several years while the number of OMP designation applications has significantly risen and new regulatory schemes such as adaptive pathways have been introduced, certain adjustments to the existing Communication 2003/C 178/02 where necessary. In this context, it is of utmost importance that, during the revision process, the positive results already achieved with regard to the approvals of OMPs in Europe are not being jeopardised through restrictions on the designation and marketing authorisation level. Thus, the EUCOPE submission highlights EUCOPE’s concerns and explains our amendment proposals in particular in relation to the definition of “significant benefit”, procedure for the reassessment of orphan criteria when two authorisation application procedures are pending in parallel, and 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.

Please find the full submission here: EUCOPE submission_15 02 2016