EMA issues updated guidance on Type II variations and marketing authorisation extensions for orphan medicines

Following publication of guidance on the application of the Orphan Regulation by the European Commission, the European Medicines Agency (EMA) has issued updated guidance to companies providing them with details of the information that need to include in a Type II variation or marketing authorisation extension for an orphan-designated medicine.

The new guidance states that for a new therapeutic indication that falls under a previously confirmed orphan designation, the EMA’s Committee for Orphan Medicinal products (COMP) must determine whether the specific scope of the variation might mean there is non-fulfilment of the orphan-designation criteria.

This guidance is applicable from 18th November 2016.

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