Transferring an orphan designation

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

United Kingdom’s (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', which also applies to orphan designation holders.

For detailed information on the practical handling of transfer applications related to orphan designations, see questions 5 and 5a of the Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure​.

These transfers of orphan designation must be fully completed before 30 March 2019.

For more information, see Brexit-related guidance for companies.

From 19 September 2018, sponsors need to use the European Medicines Agency's (EMA) IRIS system to submit all post-designation activities. EMA will not be able to process any submissions outside of IRIS. For information and guidance on using IRIS, please see Applying for orphan designation.

A transfer may result from the designation holder's commercial decision to divest the orphan designation, or be needed in anticipation of the designation holder ceasing to exist as a legal entity and the orphan designation being taken over by another legal entity.

A transfer of the orphan designation can only be initiated once a designation has been granted by the European Commission.

If there is a need to change the sponsor during validation or evaluation of the application for orphan designation, the applicant who initially applied for the orphan designation will have to withdraw the application and a new application should be submitted by the new sponsor.

Transfers of orphan designations are free of charge. If a transfer is sought for several orphan designations, a separate submission in IRIS is required for each designation.

A transfer of orphan designation does not include a transfer of marketing authorisation, which is subject to a different procedure. For more information, see Transfer of marketing authorisation: questions and answers.

Procedural guidance

To transfer an orphan designation, the current sponsor needs to submit an application using the IRIS system, together with the documents and details described in the 'Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation' (see link below).

The Agency can only provide an opinion on the transfer if all documentation is complete and satisfactory. The Agency will issue an opinion within 30 days of submission of the documentation and the opinion will be forwarded to:

  • the existing sponsor;
  • the sponsor to whom the designation will be transferred;
  • the European Commission.

If the European Commission agrees to the transfer, it will amend the decision granting the orphan designation. The transfer is valid from the date of the notification of the amended decision.

A change of name and/or address of the orphan designation holder are not considered a transfer if the holder remains the same person/legal entity. Such change should be notified through the procedure for changing the name or address of a sponsor.

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