Medicines for children

Mother giving medicine to her childThis page provides links to information about the regulation of medicines for children, including the requirements for submission of paediatric data and the European paediatric work-sharing procedures.

 

Questions and answers on UK strategy

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Requirements for submission of paediatric information required by EU Paediatric Regulation

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Guidance on requirements for 'compliance checks' during validation

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Variations to implement changes to product information following European paediatric work-sharing procedures

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Page last modified: 22 April 2010