Guidance

Legal requirements for children's medicines

An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 31 December 2020
  Show all updates

  1. 31 December 2020

     Updated to reflect changes in regulations following Brexit transition.

  2. 9 April 2019

     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.

  3. 11 March 2019

     Added information and link to new guidance page about Completed Paediatric Studies - submission, processing and assessment in the event of a no deal scenario.

  4. 18 December 2014

     First published.

Documents

Legal requirements for children's medicines

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Details

How to comply with the Human Medicines Regulations 2012, as inserted by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs), including information on

• paediatric investigation plans (PIPs)
• paediatric studies
• variation codes