In 2013 the Commission has to present a general report on experience acquired as a result of the application of the Regulation on medicinal products for pediatric use. The Regulation was seen by the legislator as a response to the absence of sufficient numbers of suitable, authorised medicinal products to treat conditions in children. The key measures were the establishment of an expert pediatric committee within the European Medicines Agency, as well as the requirement, when applying for marketing authorisation for medicines and line extensions for existing patent-protected medicines, to submit data on the use of the medicine in children in accordance with an agreed pediatric investigation plan. In preparation of this report the Commission released a public consultation document. Citizens and organisations (public and private) are welcome to contribute by 28 November 2012 at the latest. For more information on how to contribute, please read the consultation document.
430
previous post