Medicines assessed under Article 58

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Article 58 of Regulation (EC) No 726/2004 allows the European Medicines Agency's Committee for Medicinal Products for Human Use to give opinions, in co-operation with the World Health Organization, on medicinal products for human use that are intended exclusively for markets outside of the European Union.

Information on medicines assessed under Article 58 is contained in the human regulatory section. Please refer to:

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