Helen Vella Director Licensing 21 January 2011
New variations legislation . Regulation 1234/2008. . All changes subsequent to their placing on the EU market, e.g. changes to the production process, product packaging or the address of the manufacturer, are considered in legal terms as 'variations', and must be handled in accordance with a complex legislative framework: the 'Variations Regulation'.This lack of harmonisation had negative consequences in terms of the administrative burden, both for industry and national regulatory authorities21
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