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Extended EudraVigilance Medicinal
Product Dictionary Training Course #14166
1011 February 2014
Euro sites, Paris, France Key Topics
General Terms and Definitions
Registration in EudraVigilance and
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Log in to the Eudravigilance system
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Select the option to fill out extended medicinal product information
03
Provide details such as product name, dosage form, strength, route of administration, etc.
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Who needs extended eudravigilance medicinal product?
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Pharmaceutical companies
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Manufacturers of medicinal products
03
Health regulatory authorities
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What is extended eudravigilance medicinal product?
Extended EudraVigilance Medicinal Product is an electronic system for managing and analysing information on suspected adverse reactions to medicinal products that are authorised or being studied in clinical trials in the European Economic Area (EEA).
Who is required to file extended eudravigilance medicinal product?
Marketing Authorization Holders (MAHs) are required to file extended EudraVigilance Medicinal Product.
How to fill out extended eudravigilance medicinal product?
Extended EudraVigilance Medicinal Product must be filled out online through the EudraVigilance system using the required templates and following the guidelines provided.
What is the purpose of extended eudravigilance medicinal product?
The purpose of extended EudraVigilance Medicinal Product is to improve the monitoring and reporting of suspected adverse reactions to medicinal products in the EEA.
What information must be reported on extended eudravigilance medicinal product?
Extended EudraVigilance Medicinal Product requires the reporting of suspected adverse reactions, patient information, and details of the medicinal product.
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