Transcription of Medicinal products in the European Union
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Medicinal products in the European Union
Medicinal products in the European Union The legal framework for medicines for human use IN-DEPTH ANALYSIS. EPRS | European Parliamentary Research Service Author: Nicole Scholz Members' Research Service April 2015 PE EN. This paper gives a general overview of several aspects of EU legislation on human medicines. It describes relevant regulatory rules and procedures, identifies the actors involved, and highlights current practices. The document also takes stock of stakeholder views. It concludes with a snapshot of an emerging approach in medicines approval. PE ISBN 978-92-823-6827-5. doi: QA-01-15-230-EN-N. Original manuscript, in English, completed in March 2015. Disclaimer The content of this document is the sole responsibility of the author and any opinions expressed therein do not necessarily represent the official position of the European Parliament.
The first Community rules on medicinal products for human use date back 50 years. Beginning with Council Directive 65/65/EEC,6 which was introduced in the wake of the thalidomide disaster, the then-European Economic Community began developing structured legislation. The legal framework has since been continuously updated.
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