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The right to the protection of personal data is not an absolute right; it must be considered in relation to its function in society and be balanced against other fundamental rights, in accordance with the principle of proportionality.This Regulation respects all fundamental rights and observes the freedoms and principles recognised in the Charter as enshrined in the Treaties, in particular the respect for private and family life, home and communications, the protection of personal data, freedom of thought, conscience and religion, freedom of expression and information, freedom to conduct a business, the right to an effective remedy and to a fair trial, and cultural, religious and linguistic diversity.Article 8(1) of the Charter of Fundamental Rights of the European Union (the ‘Charter’) and Article 16(1) of the Treaty on the Functioning of the European Union (TFEU) provide that everyone has the right to the protection of personal data concerning him or her.

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This page provides information for sponsors on how to apply to the European Medicines Agency for orphan designation for a medicine.

Click on the image below to view a guide (flowchart) for the orphan designation process for potential sponsors.

In any of the cases mentioned above sponsors should submit the application to [email protected] the secure system, Eudralink, clearly indicating in the subject message if the application is: Sponsors should contact the online EMA Service Desk to open an account.

The Agency strongly encourages sponsors to request a presubmission meeting with the Agency prior to filing an application.

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This should allow enough time for the organisation and any amendment of the application as recommended by the EMA.

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