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A review of the concept of "similar medicinal products" in the context of orphan legislation is planned by the European Commission to revamp its regulatory framework and ensure timely access to drug products. The commission will launch a review of the Commission Regulation 847/2000 on the concept of similarity and will finalize the revision of 2003 Communication on Regulation 141/2000 on orphan medicinal products.


Source: Regulatory Focus, 29 July 2016.


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