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.
Documents
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
Updates to this page
Published 18 December 2014
Last updated 31 December 2020
show all updates
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Updated to reflect changes in regulations following Brexit transition.
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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.
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Added information and link to new guidance page about Completed Paediatric Studies - submission, processing and assessment in the event of a no deal scenario.
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First published.