Review of ‘similar medicinal products’ in context of orphan legislation

The European Commission is proposing to review the concept of ‘similar medicinal products’ in the context of the orphan legislation. The aim is to improve the implementation of the regulatory framework and to adapt the text to technical progress.

The consultation is open from 29th July to 4th November 2016.

Consultation documents can be found here and should be submitted by email to SANTE-PHARMACEUTICALS-B5@ec.europa.eu.

(In your response, please make reference to the number of the consultation topics and/or the line of the consultation document.)

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Published 29. July 2016 in News UK