Procedural Advice for Post-orphan Medicinal Product Designation Activities

On 3 July 2020 the EMA published revision 8 of the guidance for sponsors.

This guidance covers the information and procedures applicable to orphan designated products:

  • incentives
  • annual reports
  • transfer of sponsorship
  • change of sponsor’s name or address
  • amendment of designated condition
  • marketing authorisation application
  • review of the maintenance of orphan medicinal product designation at the time of marketing authorisation application
  • review of the maintenance of orphan medicinal product designation at the time of extending the therapeutic indication post-authorisation
  • withdrawal of orphan designation
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