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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 do not include information on safe and effective use in paediatric populations. , in turn, says document, leads to use of unauthorised medicinal products and/or medicines used outside their approved terms "off-label" and may result in significant risks, including lack of efficacy and/or unexpected. results, might even be fatal.

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

In December 1999 Regulation on Orphan Medicinal Products was 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, says EU Commission, "there is currently no legal provision for obliging these studies to be performed if company does not present product for use in paediatric population."

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