Changing the name or address of a sponsor

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A change in the name and/or address of the existing sponsor for an orphan designation does not require a new legal act, provided that the sponsor remains the same person or legal entity.

A change in the name and/or address should be used only after a designation has been granted by the European Commission. In case there is a need to change the sponsor’s name and/or address during validation or evaluation of the orphan designation application, the applicant should inform the Orphan Medicines Office and send the revised application form to orphandrugs@ema.europa.eu.

To apply for the change, the orphan designation(s) holder should send a signed letter (PDF) to the Agency (orphandrugs@ema.europa.eu), with a copy to the European Commission (sante-pharmaceuticals-B5@ec.europa.eu), listing EU designation(s) numbers and clearly indicating the new name and/or address and a statement that the identity of the company remains the same. If the company's name has changed, the sponsor should attach a copy of the certificate of incorporation.

The Agency and the European Commission will update their records with the new information.

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Document(s) Language Status First published Last updated Effective Date
Template - Orphan designation sponsor’s name and/or address change notification letter (English only)   2015-05-19 2016-12-12 2016-12-12