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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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How to fill out extended eudravigilance medicinal product

01

Log in to EudraVigilance system using valid credentials.

02

Select 'Medicinal Products' tab from the menu.

03

Click on 'New medicinal product' button.

04

Fill out all the required fields including product name, dosage form, route of administration, etc.

05

Provide detailed information about the medicinal product including active substance, strength, packaging details, etc.

06

Verify the information entered and submit the form for review.

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Once the form is reviewed and approved, the extended eudravigilance medicinal product is successfully filled out.

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What is extended eudravigilance medicinal product?

Extended Eudravigilance Medicinal Product refers to a specific product with detailed information on its safety profile and pharmacovigilance data.

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 can be filled out using the designated electronic submission system provided by the regulatory authorities.

What is the purpose of extended eudravigilance medicinal product?

The purpose of extended eudravigilance medicinal product is to monitor the safety and efficacy of medicinal products throughout their lifecycle.

What information must be reported on extended eudravigilance medicinal product?

Information such as adverse reactions, safety data, real-world evidence, and risk management plans must be reported on extended eudravigilance medicinal product.

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