Drug groups warn over new EU law

European patients face the prospect of medicine shortages if legislation designed to ensure the high quality of ingredients comes into force in 2013, top drug company executives have warned.

An EU law set to be implemented by July 2013 would impose higher standards of proof of the purity of any 'active pharmaceutical ingredients' – the contents of medicines – which come from outside the EU.

European Generic Medicines Association (EGA) http://www.egagenerics.com/

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF

EGA: Press Release, 14.6.12: Europe must act firmly to boost its generic medicines sector... http://www.egagenerics.com/pr-2012-06-14.htm

European Commission: Delegated Act on the principles and guidelines of good manufacturing practice for active substances for human use. Concept paper submitted for public consultation, January 2012 http://ec.europa.eu/health/files/gmp/2012_01_20_gmp_cp_en.pdf

European Commission: DG Health and Consumer Potection: Public health: Medicinal products for human use http://ec.europa.eu/health/human-use/index_en.htm

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