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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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Helen Vella Director Licensing 21 January 2011

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    1. Helen Vella Director Licensing 21 January 2011

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    26. prelicensing.mru@gov.mt

    28. 28 The information has been provided with generosity by experts in their field and is the property of the Medicines Authority. You are free to re-use the resources for non-profit use, as long as you do not infringe the Authority’s rights. If you are unsure whether you can use or re-use the material presented or their parts, please contact:

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