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Brief
'The Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, require medicines to be adequately studied in children and developed for their needs. The regulations ensure that necessary data are obtained through studies to support efficacy and safety of medicines and ultimately their authorisation in the paediatric population. Marketing Authorisation Holders must submit Paediatric Investigation Plans (PIPs) and completed paediatric studies to the Medicines and Healthcare products Regulatory Agency (MHRA). '
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