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December 2009

EC regulation on conditional approval of medicinal products

New EU rules on conditional marketing authorisations for medicines for human use came into force at the beginning of April 2006, following a Regulation issued by the Commission on 29 March 2006 (No 507/2006).
Eurordis contributed to the shaping of this important regulation by submitting comments to the Commission in Jan. 2005 on the first draft regulation on conditional approval for medicinal products.
The regulation is of particular importance to rare diseases and orphan drugs. Conditional approval addresses situations where an urgent public health need exists, and a drug in development promises significant health benefits, but full safety or efficacy testing has not been completed. Conditional approval aims at speeding the product to market.
In a situation of conditional approval, the manufacturer, or “marketing authorisation holder” is committed to fulfil post-marketing obligations to obtain a definitive authorisation, based on full safety research and testing, or the product may be withdrawn from the market.