Completion requirements
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8. Further reading
- Paediatric regulation EU (EC No 1901/2006). Available at: EUR-Lex - 02006R1901-20190128 - EN - EUR-Lex (europa.eu)
- European Commission medicines for children. Available at: Medicines for children - European Commission (europa.eu)
- EMA guideline on good pharmacovigilance practices: EMA/873138/2011 Rev 1. Available at: Good pharmacovigilance practices | European Medicines Agency (europa.eu)
- EMA Presentation: Q&A on Off-Label Use. Available at: Q&A on Off-Label Use (europa.eu)