Further Documents regarding Paediatric Regulation published
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The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMD(h) of the Heads of Medicines Agencies (HMA) has published several documents regarding Paediatric Data Assessment and responsibilities from the Paediatric Regulation. The latest documents were published in September 2008:
Best Practice Guide on Article 45 – Paediatric Regulation, EU Work Sharing Procedure: “this document was produced by the CMD(h) in order to facilitate the assessment of information about nationally authorised medicinal products (including MRP and DCP) as requested by the Paediatric Regulation in a harmonised and coordinated way.”
Questions and Answers on the Paediatric Regulation (Regulation of The European Parliament And of The Council (EC) No 1901/2006, as amended). The existing document from October 2007 was amended and new questioned with respective answers were included. A detailed section was included to discuss the question of a Global Marketing Authorisation concept applicable for the Paediatric Regulation. Another question is dealing with products considered “not authorised in the Community”. Overall, the document gives valuable assistance in questions referring to articles 7, 8, 45, 46 of the Paediatric Regulation.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.
Author: Wolfgang Schmitt On behalf of the European Compliance Academy (ECA)