§ Mr. LoveTo ask the Secretary of State for Health, pursuant to his answer of 20 July 1998,Official Report, columns 407–08, what steps he is taking to monitor the way pharmaceutical companies comply with EU guidance on the licensing of medicines in children; which companies have so far complied with this guidance; which products are being developed in accordance with this guidance; and when the application of the guidance will be extended to products already on the market. [55199]
§ Ms JowellWhen an application for a new medicinal product is assessed by the Medicines Control Agency (MCA), the presence or absence of a paediatric section to the dossier is noted.
Some companies have already complied with the guideline but neither the MCA nor the European Medicines Evaluation Agency keeps a list of those who do.
The MCA does not hold information on those products which are being developed in accordance with the guidance. Companies are not obliged to reveal product development plans to regulatory agencies.
The scope of the guidance applies to marketed products as well as to products in development.
The guidance is not legally binding.