Module 1 2021

01/07/2021

Paediatric regulation

The Organisation for Professionals in Regulatory Affairs

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• Came in to into force in December 2006 • Regulation (EC) NO 1901/2006 of the European Parliament and the Council of medicinal products for paediatric use and amending regulation (EEC) No1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No727/2004t; • Goals • To ensure high-quality research into the development of medicines for children • To ensure, over time, that the majority of medicines used by children are specifically authorized for such use with appropriate forms and formulations • To ensure the availability of high-quality information about medicines used by children • Aims should be achieved without subjec ting children to unnecessary clinical trials Paediatric regulation:

The Organisation for Professionals in Regulatory Affairs

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