Transferring an orphan designation

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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.

Such 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 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. In case 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 is advised to contact the Agency at

Transfers of orphan designations are free of charge. In case a transfer is sought for several orphan designations, an application must be submitted for each designation (i.e. one application per designation).

A transfer of an orphan designation does not include a transfer of marketing authorisation as this is subject to a different procedure (see: Transfer of marketing authorisation: questions and answers).

United Kingdom’s (UK) withdrawal from the EU (new)

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA).

The European Commission/EMA notice to marketing authorisation holders also applies to orphan designation holders.

EMA’s practical guidance document for procedures related to Brexit contains detailed information on handling applications for transferring an orphan designation.

For more information, see UK’s withdrawal from the EU.

Procedural guidance

On 19 June 2018, EMA launched a new secure online portal for sponsors to submit applications for orphan designation and to manage post-designation activities. For more information, see Applying for orphan designation.

To transfer an orphan designation, the sponsor needs to submit an application to, together with the documents described in the 'Checklist for sponsors applying for the transfer of orphan medicinal product designation' .

The Agency can only provide an opinion on the transfer if all of the documentation required 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 accepted 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 and is subject to a different procedure. Such change should be notified through a change of name and/or address of the orphan designation holder procedure.


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Document(s) Language Status First published Last updated Effective Date
Checklist for sponsors applying for the transfer of orphan medicinal product designation (English only)   2009-01-15 2017-12-01  
Template 1 - Orphan designation transfer form (English only)   2016-04-13 2016-12-13  
Template 2 - Translations of the active ingredient and indication for transfer of orphan-medicinal-product designation (English only)   2008-11-24 2013-07-04