Orphan medicines
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List item
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 (PDF/185.35 KB)
Adopted
First published: 14/02/2012
Last updated: 14/02/2012
Legal effective date: 13/02/2012
SOP/H/3371 -
List item
Standard operating procedure for preparation of the public summary of opinion for orphan medicinal product designation (PDF/189.88 KB)
Adopted
First published: 11/06/2007
Last updated: 02/09/2011
Legal effective date: 05/09/2011
SOP/H/3046