CASE COMMENT: REGULATORY - HEALTH CARE - DRUGS TARIFS
Health care: The ECJ and a Decree dated January, 20, 2005 set up a new framework designed to foster the sales of generic drugs (Lilly - SKB - Décret du 18/02/05)
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– ECJ, 9 December 2004, Approved Prescription Services v. Licensing Authority, Case C-36/03.
– ECJ, 20 January 2005, SmithKline Beecham, Case C-74/03
– Decree No. 2005-156 of 18 February 2005 on changes to marketing authorisations for medicinal products for human use and amending the Public Health Code
Competition between pharmaceutical companies and generic manufacturers is multi-faceted. One of the least known to the general public concerns the data that must be provided to the health authorities (in France, AFSSAPS) to obtain marketing authorisation (MA). When a medicinal product is first placed on the market for the first time - as a speciality
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