Procedure for orphan medicinal product designation: an update

Procedure for orphan medicinal product designation: an update

The European Medicines Agency (EMA), based on the opinions on orphan designation (OD) adopted by the Committee for Orphan Medicinal Product (COMP), has released a Guidance  for Sponsors to submit an application via the current existing submission process until 19 September 2018.  Nevertheless, starting from 19 June 2018 onwards, organisations seeking to apply to the EMA for a product to be considered for orphan designation will be able to follow a new process. This new process, which will become mandatory after 19 September 2018, requires some steps to be completed before any activity relating to an orphan designation procedure can be carried out using the new IRIS Portal, in particular:

  • Both the Applicant and Sponsor of an orphan designation, or persons acting on their behalf, must have an active EMA user account and must be registered with IRIS user access roles of either ‘Orphan Industry Manager’ or ‘Orphan Industry Contributor’.
  • The ‘Organisation’ for which the OD application is being submitted must be registered in the EMA’s Organisation Management System (OMS).
  • The ‘Substance(s)’ for which the application is being submitted must be registered and appear on the official EMA list of all substances, the European Union Telematics Controlled Terms (EUTCT) database.
  • Each new OD application must have a Research Product Identifier (RPI) – the process for requesting an RPI will be covered in the ‘Quick Guide to the IRIS Portal’.

The instructions in this guide involve visiting 3 different data and user management portals, all of which sit, for data security reasons, outside the EMA website.

You can find further details on “IRIS Quick guide to registration” here.

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