23/10/2006 (Agence Europe) - On Monday 23 October, the Council of Ministers in Luxembourg formally adopted the new regulation on medicinal products for paediatric use. On the basis of the agreement reached with the European Parliament, the main obligation is that a paediatric investigation plan must be submitted as part of the procedure for obtaining market authorisation, while incentives are provided through the extension of exclusive rights and the introduction of a new type of market authorisation for generic medicines. The regulation, which completes the Community's pharmaceutical legislation, was necessary to ensure that children have access to more suitable medicines. To date, the dosage for children was simply calculated according to the weight of the child (see EUROPE 9203). (oj)