Get the free eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide
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6 April 2018 EMA/467742/2014 Information ManagementeXtended EudraVigilance Medicinal Product Dictionary (DEEMED) Stepsister Guide Insert of an Organisation30 Churchill Place Canary Wharf London E14
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How to fill out extended eudravigilance medicinal product
How to fill out extended eudravigilance medicinal product
01
Login to the EudraVigilance web application using your credentials.
02
Navigate to the 'Medicinal Products' section.
03
Select the 'Extended EudraVigilance Medicinal Product' option.
04
Click on 'Create New' to start filling out the form.
05
Enter the mandatory information such as product name, active substances, dosage form, route of administration, and manufacturer details.
06
Provide additional details like product classification, packaging information, and regulatory information.
07
Upload supporting documents if required.
08
Review the completed form for any errors or missing information.
09
Submit the form and wait for approval or further instructions.
10
Make sure to keep a copy of the completed form for future reference.
Who needs extended eudravigilance medicinal product?
01
Pharmaceutical companies and organizations involved in the development, manufacture, and distribution of medicinal products
02
Health authorities and regulatory agencies responsible for monitoring and ensuring the safety and efficacy of medicinal products
03
Healthcare professionals, including doctors, pharmacists, and nurses, who need access to comprehensive and up-to-date information about medicinal products
04
Researchers and scientists involved in pharmacovigilance and drug safety studies
05
Patients and consumer advocacy groups who are interested in understanding the safety profile and potential adverse effects of medicinal products
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What is extended eudravigilance medicinal product?
Extended Eudravigilance Medicinal Product is a system used for the electronic reporting and management of suspected adverse reactions during the post-authorization phase of a medicinal product.
Who is required to file extended eudravigilance medicinal product?
Marketing authorization holders and sponsors are required to file extended Eudravigilance Medicinal Product.
How to fill out extended eudravigilance medicinal product?
Extended Eudravigilance Medicinal Product can be filled out electronically through the Eudravigilance system following the specific reporting guidelines provided.
What is the purpose of extended eudravigilance medicinal product?
The purpose of extended Eudravigilance Medicinal Product is to monitor and gather information on the safety and efficacy of medicinal products after they have been authorized for marketing.
What information must be reported on extended eudravigilance medicinal product?
Information such as suspected adverse reactions, patient demographics, concomitant medications, and outcome of the reaction must be reported on extended Eudravigilance Medicinal Product.
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