Paediatric medicines

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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure for confirmation of applicability of the EMA’s decision on class waivers (English only) adopted 2015-10-09   2015-10-05
Standard operating procedure for paediatric investigation plan or a waiver from pre-submission to start of procedure (English only) adopted 2015-10-09 2017-02-27 2017-02-15
Standard operating procedure for Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion (English only) adopted 2015-10-09 2017-12-01 2017-12-01
Standard operating procedure for paediatric investigation plan from re-start of procedure (after clock-stop) to PDCO opinion (English only) adopted 2009-07-03 2017-12-01 2017-12-01
Standard operating procedure for re-examination of Paediatric Committee opinions (English only) adopted 2010-10-07 2017-12-01 2017-12-01
Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions (English only) adopted 2017-12-08   2017-12-15
Standard operating procedure for compliance check of an agreed paediatric investigation plan (English only) adopted 2017-12-08   2017-12-15
Standard operating procedure for modification of an agreed paediatric investigation plan (English only) adopted 2012-09-14 2017-12-01 2017-12-01
Work instructions for paediatric core master files and numbering (English only) adopted 2009-03-18 2017-02-27 2017-02-15
Standard operating procedure for rectifying errors in PDCO opinions and European Medicines Agency decisions (English only) adopted 2012-07-27 2017-12-01 2017-12-01
Work instructions for review of granted paediatric product-specific and class waivers (English only) adopted 2013-05-13 2017-02-27 2017-02-15