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EMA Releases New Guidance on Type II Variations and MA Extensions of Orphan Drugs

December 13, 2016

The European Medicines Agency (EMA) released an updated version of its post-authorization guidance on the effects of extensions of marketing authorizations and type II variations on orphan-designated medicines.

Among the contents of the document are:

  • Consideration of EMA’s Committee for Orphan Medicinal products (COMP) whether the specific scope of the variation raises justified and serious doubts in respect to the fulfillment of the orphan-designation criteria for “new therapeutic indication under a previously confirmed orphan designation”
  • Confirmation by COMP of the maintenance of the orphan designation before authorization of the new indication for a “new therapeutic indication under a new orphan designation”

The guidance was released on November 18, 2016.

Source URL: Regulatory information – New guidance on type II variations and marketing authorization extensions for orphan-designated medicines