A transfer of the orphan designation is the procedure by which the orphan designation is transferred from the currently approved sponsor (orphan designation holder) to a new sponsor which is a different person/legal entity.

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Question 1

Answer 1

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  Checklist for sponsors applying for the transfer of orphan medicinal product designation (PDF - 230kb)

  Published 15/01/2009
  Updated 13/11/2017
• Available languages (3)

  • French

    (230 kB - PDF)
    (230 kB - PDF)
  • German

    (230 kB - PDF)
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  • Spanish

    (230 kB - PDF)
    (230 kB - PDF)
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  Template 1 - Orphan designation transfer form (DOC - 512kb)

  Published 13/04/2016
  Updated 13/12/2016
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  Template 2 - Translations of the active ingredient and indication for transfer of orphan-medicinal-product designation (DOCX - 132kb)

  Published 24/11/2008
  Updated 04/07/2013

• Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designation from one sponsor to another