On 19 January 2006, EFA and the International Primary Care Respiratory Group (IPCRG) submitted comments to the European Medicines Agency (EMEA) draft “Guideline on conduct of pharmacovigilance for medicines used by the paediatric population” outlining the danger of prescribing unlicensed medicines for children. We are particularly concerned about the small number of thorough dose-ranging studies in children with asthma of inhaled medicines, in allergic rhinitis and atopic eczema. The guideline is designed as preparatory work for the implementation of the proposed EU paediatric medicines regulation once it comes into force, since this also contains a number of provisions on pharmacovigilance (safety of medicines). We will keep you informed of any feedback we receive.

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The EFA Team