The EU Paediatric Regulation (Regulation 1901/2006) entered into force approximately 10 years before October 2017.
Notes on verification
Confirmed by multiple independent sources including EMA official documents, press releases, and peer-reviewed journal articles. Regulation entered into force 26 January 2007, consistent with the 'ten-year report' published by the European Commission in October 2017. [tier=gold indep_score=0.983 clusters=3 claim_tier=everyday | kind=empirical eligibility=high (extractor: empirical/medium)]
Sources
- Farmacoepidemiologia documentazione in Europa (seed:health_and_medicine)
- https://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overview/paediatric-regulation (corroboration)
- 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 (corroboration)
- https://www.bfarm.de/EN/Medicinal-products/Licensing/Medicines-for-children/EU-Regulation-Medicinal-Products-Children/eureg-hinweise-en.html (corroboration)
- https://www.ema.europa.eu/en/documents/press-release/emea-prepares-entry-force-new-legislation-paediatric-medicines_en.pdf (corroboration)
- https://link.springer.com/article/10.1007/s00228-011-0997-4 (corroboration)