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Paediatric Regulation Q&A.pdf

CMDh_007_2007_Rev11_2021_09_clean_Q_A_on_the_Paediatric_Regulation.pdf
Preview of Paediatric Regulation Q&A
🔗 Source: hma.eu
📊 Size: 362 KB
👤 Author: European Medicines Agency
⬇️ Downloads: 72

Summary

Articles 45 and 46 of the Paediatric Regulation apply to all medicinal products, regardless of authorization route. The obligations apply to all authorized products, including generics, hybrids, and traditional herbal products. Marketing Authorization Holders must submit completed pediatric studies to competent authorities within 6 months of completion, including studies conducted in pediatric and adult populations. Submissions should include clinical and non-clinical studies, and may require amendments to product information. Competent authorities will assess submissions, with the EMA handling centrally authorized products and national authorities handling nationally authorized products.

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Description

Articles 45 and 46 of the Paediatric Regulation apply to all medicinal products, regardless of authorization route.

Technical Information

  • File Format: PDF
  • File Size: 362 KB
  • Pages: 8
  • Language: EN
  • Author: European Medicines Agency
  • Total Downloads: 72
  • Last Updated: 1 week ago

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