Advice on the submission of information about use of authorised medicinal products in children as required by Articles 45 and 46 of the Paediatric Medicines Regulation (EC) no. 1901/2006
The European Regulation (EC) 1901/2006 relating to medicines for children came into force on 26 January 2007, and is directly applicable in Member States.
The Regulation aims to make high-quality, safe and efficient medicines accessible to children and adolescents. Therefore, the Regulation specifies the requirements for the development and authorisation of new medicinal products. It further requires the submission of line listings of studies already conducted with children and adolescents in connection with authorised products (see Articles 45 and 46 of the Regulation).
The purpose of these activities are:
- to reassess safety and efficiency and to avoid exposure of children and adolescents to improper treatment due to overdosing or underdosing or inappropriate dosage forms or inadequately verified dose recommendations;
- to avoid clinical trials with children if appropriate data are already in place for deriving proper therapeutic recommendations;
- to ensure qualified selection of products eligible for the paediatric symbol (see Art. 32 of the Regulation);
- to update package leaflet and expert information/SPC, where necessary, in accordance with the presented information (available doses or formulations).
For authorised medicinal products, Article 45 requires authorisation holders to submit for assessment any paediatric studies already completed before the new Regulation came into force, by 26 January 2008.According to Article 46, all other studies relating to the use of an authorised medicinal product in children should be submitted to the competent authority within six months of completion.The studies are assessed by European experts within the “Paediatric Worksharing Project“, for the benefit of efficient and harmonised assessment and uniform information derived from it for physicians and patients.
EU Member States and EMA have agreed on a harmonised procedure for submission of the required data and studies by pharmaceutical companies. The ”Procedural Guidance concerning submission of information about medicinal products as requested by the Paediatric Regulation“ as well as the relevant forms and questions and answers (Q&A) are published at the CMD-h websites.
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