Paediatric medicines
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Standard operating procedure for paediatric investigation plan or a waiver from pre-submission to start of procedure (PDF/150.19 KB)
Adopted
First published: 09/10/2015
Last updated: 27/02/2017
Legal effective date: 15/02/2017
SOP/H/3451 -
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Standard operating procedure for Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion (PDF/137.46 KB)
Adopted
First published: 09/10/2015
Last updated: 23/05/2018
Legal effective date: 01/12/2017
SOP/H/3452 -
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Standard operating procedure for paediatric investigation plan from re-start of procedure (after clock-stop) to PDCO opinion (PDF/132.31 KB)
Adopted
First published: 03/07/2009
Last updated: 01/12/2017
Legal effective date: 01/12/2017
SOP/H/3453 -
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Standard operating procedure for re-examination of Paediatric Committee opinions (PDF/157.71 KB)
Adopted
First published: 07/10/2010
Last updated: 01/12/2017
Legal effective date: 01/12/2017
SOP/H/3454 -
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Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions (PDF/143.66 KB)
Adopted
First published: 08/12/2017
Last updated: 08/12/2017
Legal effective date: 15/12/2017
SOP/H/3455 -
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Standard operating procedure for compliance check of an agreed paediatric investigation plan (PDF/155.37 KB)
Adopted
First published: 08/12/2017
Last updated: 08/12/2017
Legal effective date: 15/12/2017
SOP/H/3456 -
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Standard operating procedure for modification of an agreed paediatric investigation plan (PDF/138.21 KB)
Adopted
First published: 14/09/2012
Last updated: 01/12/2017
Legal effective date: 01/12/2017
SOP/H/3457 -
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Work instructions for paediatric core master files and numbering (PDF/103.74 KB)
Adopted
First published: 18/03/2009
Last updated: 27/02/2017
Legal effective date: 15/02/2017
WIN/H/3459 -
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Standard operating procedure for rectifying errors in PDCO opinions and European Medicines Agency decisions (PDF/145.34 KB)
Adopted
First published: 27/07/2012
Last updated: 01/12/2017
Legal effective date: 01/12/2017
SOP/H/3458 -
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Work instructions for review of granted paediatric product-specific and class waivers (PDF/96.02 KB)
Adopted
First published: 13/05/2013
Last updated: 27/02/2017
Legal effective date: 15/02/2017
WIN/H/3460