Orphan medicines
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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 ext... (PDF/290.82 KB)
Adopted
First published: 05/06/2018
Last updated: 05/06/2018
Legal effective date: 30/05/2018
WIN/H/3372 -
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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 i... (PDF/294.91 KB)
Adopted
First published: 05/06/2018
Last updated: 05/06/2018
Legal effective date: 30/05/2018
WIN/H/3530 -
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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 -
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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 -
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Work instructions on orphan electronic product folders (PDF/148.73 KB)
Adopted
First published: 10/02/2016
Last updated: 13/06/2017
Legal effective date: 12/06/2017
WIN/H/3047 -
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Standard operating procedure for orphan-medicinal-product designation and amendment of an existing orphan-medicinal-product designation (PDF/402.17 KB)
Adopted
First published: 15/10/2007
Last updated: 10/02/2016
Legal effective date: 09/02/2016
SOP/H/3049 -
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Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (PDF/409.03 KB)
Adopted
First published: 08/10/2007
Last updated: 12/11/2019
Legal effective date: 18/10/2019
SOP/H/3190