Guidance

Legal requirements for children's medicines

• From: Medicines and Healthcare products Regulatory Agency
• Part of: Patient safety and Marketing authorisations, variations and licensing guidance
• Published: 18 December 2014

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.

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.

Document information

Published: 18 December 2014

From: Medicines and Healthcare products Regulatory Agency

Part of: Patient safety Marketing authorisations, variations and licensing guidance