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March 4, 2026
Approximately 5 minutes
Legal Requirements for Children's Medicines in the UK
Legal Requirements for Children's Medicines in the UK
1. Introduction
The Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs), contain provisions to ensure medicines are adequately studied in children and developed to meet their needs, including age-appropriate formulations. These regulations require the submission of paediatric investigation plans (PIPs) and completed paediatric studies to the Medicines and Healthcare products Regulatory Agency (MHRA). https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines/legal-requirements-for-childrens-medicines The aim is to obtain necessary data through studies to support the efficacy and safety of medicines for authorisation in the paediatric population and to increase available paediatric information.
2. Paediatric Investigation Plans (PIPs)
A PIP is required for new medicines or certain developments of licensed medicines unless a waiver is granted. It outlines the studies needed to evaluate the medicine in children. Submissions must be made no later than the completion of human pharmacokinetic studies in adults. https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines/legal-requirements-for-childrens-medicines Applications for marketing authorisations falling under specific regulations must cover all subsets of the paediatric population unless grounds for a waiver exist.
3. Paediatric Studies
Studies in children are mandatory to support marketing authorisations where appropriate. The regulations ensure data are obtained to support paediatric use. Completed studies sponsored by marketing authorisation holders (MAHs) must be submitted to MHRA. https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines/legal-requirements-for-childrens-medicines
4. Variation Codes
Variations to marketing authorisations for paediatric developments may require specific codes. This includes new indications, formulations, or routes of administration for children.
5. New Formulations for Children
Age-appropriate formulations are encouraged to meet children's needs. The regulations promote the development of suitable pharmaceutical forms for paediatric use.
6. Excipients
Excipients in children's medicines must be evaluated for safety in the paediatric population. Specific guidance on excipients like preservatives and sweeteners is provided.
7. Clinical Trials in Children
Clinical trials involving children must comply with the Clinical Trials Regulations 2004, implementing the EU Clinical Trials Directive. Ethical considerations and informed consent are crucial. https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines/legal-requirements-for-childrens-medicines
8. Labelling
Labelling must include age-specific information, dosage instructions, and warnings suitable for children. Inclusion of age is a legal requirement for prescription-only medicines for children under 12.
9. Packaging
Packaging should be child-resistant where appropriate and designed to minimise risks in paediatric use.
10. Patient Information Leaflets
Patient information leaflets (PILs) must be clear, age-appropriate, and include specific instructions for use in children.
11. Pharmacovigilance
Enhanced pharmacovigilance is required for children's medicines, including monitoring adverse reactions in paediatric populations. Reporting obligations apply to ensure ongoing safety assessment.
12. Class Waivers
For certain medicines or classes, PIP submission is waived if they are likely ineffective or unsafe in children, intended only for adults, or offer no significant benefit over existing treatments. MHRA maintains a list of class waivers. https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines/legal-requirements-for-childrens-medicines
13. Publication and Updates
Published 18 December 2014, last updated with details on compliance with HMRs. https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines/legal-requirements-for-childrens-medicines
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