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
Last updated 9 April 2019 — see all updates
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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Details

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

Published 18 December 2014
Last updated 9 April 2019 + show all updates
  1. Link to new guidance on procedures for UK-PIPs in the event the UK leaves the EU without a deal has been added to the page.
  2. Added information and link to new guidance page about Completed Paediatric Studies - submission, processing and assessment in the event of a no deal scenario.
  3. First published.