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EC consults on orphan drug application guidelines

Also seeks input on the transfer of designations from one sponsor to another

The European Commission (EC) has put its proposed guideline on the format and content of applications for orphan drug status out to public consultation.

The proposed guideline provides supplementary advice on how to compile the documents that should be provided by sponsors in an application for orphan medicinal product designation

It also covers the provision of advice to sponsors wishing to transfer the designation of an orphan medicinal product and/or to change the name or address of a sponsor.

• Comments and suggestions are invited by September, 30 and should emailed to: sanco-pharmaceuticals-d5@ec.europa.eu

19th July 2013

From: Regulatory

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