The EU Paediatric Regulation (Regulation 1901/2006) entered into force approximately 10 years before October 2017.
Sources
- Farmacoepidemiologia documentazione in Europa (epicentro.iss.it)
- https://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overview/paediatric-regulation (ema.europa.eu)
- https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-regulatory-aspects-regulation-ec-no-19012006-paediatric-regulation-amended-regulation-ec-no-19022006_en.pdf (ema.europa.eu)
- https://www.bfarm.de/EN/Medicinal-products/Licensing/Medicines-for-children/EU-Regulation-Medicinal-Products-Children/eureg-hinweise-en.html (bfarm.de)
- https://www.ema.europa.eu/en/documents/press-release/emea-prepares-entry-force-new-legislation-paediatric-medicines_en.pdf (ema.europa.eu)
- https://link.springer.com/article/10.1007/s00228-011-0997-4 (link.springer.com)
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