Joint answer given by Mr Andriukaitis on behalf of the Commission
Written questions: P-007464/17 , P-007342/17

8.1.2018

The Commission is aware of an ongoing procedure at the European Medicines Agency (EMA) for a marketing authorisation application for a medicinal product for treatment of multiple myeloma, containing an active substance plitidepsin.

The Commission has been informed by representatives of the applicant about concerns regarding the procedure. The scientific assessment is the responsibility of the EMA. The Commission relies on the Agency as regards the procedures of scientific evaluation. In accordance with EMA procedures, the applicant has several opportunities to present data in favour of their application. Due to the fact that this is a pending procedure, the Commission is not in position to further comment on it.

The Commission will proceed with the decision-making process as regards the application once the final opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) has been received.