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

This file may not be suitable for users of assistive technology. Request an accessible format.

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.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Where paediatric data is assessed

PDF, 474KB, 1 page

This file may not be suitable for users of assistive technology. Request an accessible format.

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.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
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.