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Licensed medicines, off-label use or evidence-based. Which is most important?
  1. Maurizio Bonati1,
  2. Evelyne Jacqz-Aigrain2,
  3. Imti Choonara3
  1. 1Laboratory for Mother and Child Health, Department of Public Health, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
  2. 2Department of Paediatric Pharmacology and Pharmacogenetics, CIC1426 Inserm/APHP, University Paris Diderot, Robert Debre Hospital, Paris, France
  3. 3Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK
  1. Correspondence to Emeritus Professor Imti Choonara, Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK; imti.choonara{at}

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Medicines are licensed for use in humans by regulatory authorities. The concept of licensing is that it helps ensure that medicines are safe, effective and of an adequate quality for regular use.1 Licensing was introduced due to concerns about safety not to ensure that medicines are effective. It was a response to specific examples of drug toxicity, notably the grey baby syndrome in neonates following the use of the antibiotic chloramphenicol and phocomelia in the developing fetus following ingestion of thalidomide by pregnant women.2 Within the UK, the Medicines Act was passed in 1968. The licensing of medicines is both a control on products of public interest as well as an authorisation to sell for pharmaceutical companies. Pharmaceutical companies are only allowed to promote licensed medicines. Prescribers, however, are free to prescribe the most appropriate medicine for their patient. This should be based on the best available scientific evidence. Medicines can be licensed (authorised) by either national regulatory agencies (national route) or the European Medicines Agency …

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