Orphans: Regulatory and Procedural Guidance and Forms

9 June 2022 — EMA announced updated procedural guidance documents on orphan designation.

The following regulatory and procedural guidance and forms on orphan designation were updated:

  • Template - Translations required with the submission of an application for orphan medicinal product designation
  • Procedural advice for post-orphan medicinal product designation activities:

Guidance for sponsors

  • Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation
  • Template - Translations required with the submission of an application for transfer of orphan medicinal product designation
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