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VIRTUAL Overextended EudraVigilance Medicinal Product Dictionary Training CourseOVERVIEW The submission of data on medicines by marketingauthorisation holders is a legal requirement from Article 57(2)
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To fill out wwwemaeuropaeuendocumentsextended eudravigilance medicinal product, follow these steps:
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Fill out all the required fields of the form, such as product details, batch number, manufacturing information, etc.
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wwwemaeuropaeuendocumentsextended eudravigilance medicinal product is needed by pharmaceutical companies, manufacturers, and distributors who want to report adverse effects or safety issues related to their medicinal products to the EMA (European Medicines Agency). It is also required for regulatory compliance purposes.
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Extended Eudravigilance Medicinal Product is a system for electronically reporting information on suspected adverse reactions and events related to medicinal products.
Marketing authorization holders are required to file the Extended Eudravigilance Medicinal Product.
The Extended Eudravigilance Medicinal Product can be filled out electronically through the EudraVigilance system following the provided guidelines and templates.
The purpose of the Extended Eudravigilance Medicinal Product is to ensure the safety and monitoring of medicinal products in the EU market.
The information to be reported on the Extended Eudravigilance Medicinal Product includes suspected adverse reactions, events, and any relevant details related to medicinal products.
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