Global Authorisation: Intention and Reality

The declared purpose of the 2001 Community Code on Medicinal Products was, in the interests of clarity and rationalization, to codify and consolidate into a single text the existing EU legislative provisions on medicinal products for human use. However, has the clash between the need for innovation and the desire to encourage generic medicines led to unintended, and in some areas unwelcome, consequences? Elisabethann Wright examines the debate.


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