The Commission would like to inform the Honourable Member that on 3 January 2018 the applicant for a marketing authorisation of the medicinal product Aplidin (plitidepsin), Pharma Mar, S.A., requested a re-examination of the opinion of the Committee for Medicinal Products for Human Use (CHMP) which was adopted on 14 December 2017. The CHMP in its plenary meeting in January 2018 appointed re-examination rapporteurs and noted the draft re-examination timetable. The re-examination opinion is expected to be adopted in April 2018.

Some information on the CHMP's initial assessment of Aplidin is available in the European Medicines Agency (EMA) website(1). The Commission is not in a position to disclose elements of the ongoing assessment. Following receipt of the CHMP's final opinion, a Commission decision will be adopted. As for all medicinal products, after adoption of the Commission decision, the EMA will publish standard documents related to the assessment on its website.

Decisions on a marketing authorisation of a medicinal product may differ between different jurisdictions, because of different legal requirements and the scientific evaluation being independent from each other.

(1) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004354/smops/Negative/human_smop_001242.jsp&mid=WC0b01ac058001d127