EU PLOTS HAMONISATION OF NATIONAL MARKET AUTHORISATION VARIATION RULES
February 1st, 2012
BY KEITH NUTHALL
THE EUROPEAN Commission is pushing forward with developing proposals to harmonise the way that European Union (EU) member states allow variations to national marketing authorisations for pharmaceutical products. It is considering revising the EU's variations regulation (EC) No. 1234/2008 to help companies make and abide by these legal changes. The idea has been welcomed by the Bundesverband der Pharmazeutischen Industrie (BPI), Germany's pharmaceutical industry association, which said in formal consultation: "...different variation ...
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