The European Medicines Agency is carrying out a survey to gather information on your current experience with the Orphan Maintenance Assessment Reports (OMARs) / Orphan Designation Withdrawal Assessment Reports resulting from the review by the Committee for Orphan Medicinal Products (COMP) of the orphan designation criteria at the time of marketing authorisation application.
The OMAR was introduced to bridge the gap of publicly available information between the marketing authorisation and the review of the orphan criteria and to increase transparency of the assessment.
This survey and the data collected will provide valuable feedback to help the continuous improvement of the OMAR procedure and output. The results of the survey will be made public on EMA website.
An electronic link to the survey is included below. The survey will be open until 10 December 2021: https://ec.europa.eu/eusurvey/runner/OMARSurvey2021