Ruairi Quinn (Dublin South East, Labour)
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Question 314: To ask the Tánaiste and Minister for Health and Children if EU Directive 2005/28/EC will be implemented before 29 January 2006; if the directive will not be implemented by 29 January 2006 the reason Ireland will not meet its obligations to implement this directive before the deadline; and if she will make a statement on the matter. [1108/06]

Mary Harney (Dublin Mid West, Progressive Democrats)
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The Government is conscious of the need to ensure Ireland's treaty commitments are met by transposing EU legislation as required. In this context, the Department of Health and Children continues to make every effort, within its available resources, to ensure that relevant EU measures are transposed into Irish law in a timely manner.

While certain elements of Directive 2005/28/EC had been anticipated when Directive 2001/20/EC was being implemented in this country via the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, it will be necessary to introduce some amendments to these regulations to conform fully with the requirements of Directive 2005/28/EC.

In light of the considerable volume of legislation in respect of medicinal products, arising from this country's EU obligations, which is currently being prepared by the Department, it is not expected that the steps necessary for the full implementation of Directive 2005/28/EC will be completed until later in the year.