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Better medicines for children: EU Commission initiative to get best and safest treatments for children Part 4 (Teacher: Michael)

Medicines available in Europe frequently not include information on safe and effective in paediatric populations. This, in , the document, leads to the of unauthorised medicinal products and/or medicines outside their approved terms "off-label" and result in significant risks, including lack of efficacy and/or unexpected. results, that fatal.

The initial process of providing a remedy to this situation traced to 1997 when a round organised by the EU Commission in the premises of the European Agency for the Evaluation of Medicinal products. The following year the Commission supported the for international discussion of the performance of clinical trials in children and an International Conference on Harmonisation guideline adopted in July 2000.

In December 1999 the Regulation on Orphan Medicinal Products adopted.

Directive 2001/20/EC on Good Clinical Practice, adopted in April 2001, also takes into account some specific concerns of performing clinical trials in children.

However, the EU Commission, "there is currently no legal provision for obliging these studies to performed if the company not present the product for in the paediatric population."

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