Guidance

Legal requirements for children's medicines

When to carry out a paediatric investigation plan (PIP) and or a paediatric study for a children's medicine or apply for a change to it.

Published 18 December 2014

• From: Medicines and Healthcare products Regulatory Agency

Documents

Legal requirements for children's medicines

HTML

Implementation of changes to product information

PDF, 132KB, 5 pages

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Where paediatric data is assessed

PDF, 474KB, 1 page

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

Information on PIPs, paediatric studies and variations to children’s medicines.

Published 18 December 2014