CRED SMPC 2024

23/09/2024

Regulation (EC) No 1901/2006

The Paediatric Regulation came into force in the EU on 26 th January, 2007

Article 17: “ To provide healthcare professionals and patients with information on the safe and effective use of medicinal products in the paediatric population , and as a transparency measure, information on the results of studies as well as on the status of the paediatric plans, waivers and deferrals, should be included in the product information”.

The Organisation for Professionals in Regulatory Affairs

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EC Paediatric Regulation Objectives

● 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 authorised for such use.

● To ensure the availability of high-quality information about medicines used by children;

The Organisation for Professionals in Regulatory Affairs

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