Orphan medicines

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Document(s) Language Status First published Last updated Effective Date
Work instructions for preparation of an Orphan Maintenance Assessment Report (OMAR) following a positive or negative opinion on the maintenance of the orphan designation criteria at time of marketing authorisation or extension of indication (English only) adopted 2018-06-05   2018-05-30
Work instructions for preparation of a Withdrawal Assessment Report - Orphan Maintenance following the request of withdrawal of an orphan designation after COMP review at time of marketing authorisation or extension of indication (English only) adopted 2018-06-05   2018-05-30
Standard operating procedure on preparation and publication of the public summary of opinion on the review of orphan designation at the time of granting/varying a marketing authorisation (English only) adopted 2012-02-14   2012-02-13
Standard operating procedure for preparation of the public summary of opinion for orphan medicinal product designation (English only) adopted 2007-06-11 2011-09-02 2011-09-05
Work instructions on orphan electronic product folders (English only) adopted 2016-02-10 2017-06-13 2017-06-12
Standard operating procedure for orphan-medicinal-product designation and amendment of an existing orphan-medicinal-product designation (English only) adopted 2007-10-15 2016-02-10 2016-02-09
Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (English only) adopted 2007-10-08 2017-10-19 2017-10-04