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Partnership Initiative between Ireland, the UK and Belgium for National Variation Applications

The Veterinary Medicines Department of the IMB and the UK's Veterinary Medicines Directorate (VMD) began a work-sharing initiative for certain national Type II variations in June 2008.  This is known as a 'Partnership Initiative'.  Since 24th September 2010, the initiative has been extended to include the medicines agency in Belgium and since 10th October 2011, the initiative has been extended to include the medicines agency in Netherlands.

Marketing authorisation holders (MAHs) often submit the same national variation applications to a number of countries. Where the supporting data are identical and the originally-submitted data for the product concerned are very similar, a lead country is appointed to conduct the assessment of the data. The non-lead countries may also input into the assessment in accordance with an agreed timetable. MAHs that choose to use the procedure benefit by receiving a single list of questions from the involved countries in accordance with a fixed timeframe.

Details of the initiative are available in the Clarification Paper: Partnership Initiative between the UK, Ireland and Belgium for National application procedures.


Date Printed: 17 May 2012

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