The colourful and rather exotic Italian English-language weblog Catch Us If You Can !!! carries a short
post by Mauro Turrini, "Pharmaceuticals for paediatric use". This item summarises the effect of Regulation 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and reminds readers that there is a significant SPC-related calendar date next month:
"The Paediatric Regulation introduces the requirement to include information about paediatric studies in the Marketing Authorisation (MA) application. This requirement, already mandatory for new medicinal products as from 26 July 2008, will start soon to be compulsory also for previously authorised medicinal products covered by a supplementary protection certificate (SPC) or a patent, which qualifies for the granting of the SPC (as from 26 January 2009)".
The colourful and rather exotic Italian English-language weblog Catch Us If You Can !!! carries a short post by Mauro Turrini, "Pharmaceuticals for paediatric use". This item summarises the effect of Regulation 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and reminds readers that there is a significant SPC-related calendar date next month:
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