Orphan medicines

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Document(s) Language Status First published Last updated Effective Date
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 2017-01-10 2016-02-09