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9 paragraph 104. http //www. ema.europa.eu/ema/index. jsp curl pages/regulation/documentlisting/document listing000336. II XEVPRM User Guidance Legal Notice on the Implementation of Article 57 2 of Regulation EC No. 726/2004 Electronic submission of Article 57 2 data - Questions Answers Q As Training in developing messages compliant with the published XEVPRM XSD schemas Hands-on training using the XEVMPD to generate XEVPRMs the detailed guidance CT-3 and the electronic submission of...
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Step 1: Open the extended EudraVigilance Medicinal Product application form.
02
Step 2: Fill out the required fields, such as the name of the medicinal product and its marketing authorization number.
03
Step 3: Provide detailed information about the medicinal product, including its formulation, dosage form, strength, and packaging details.
04
Step 4: Fill in the information regarding the product manufacturer, including their name, address, and contact details.
05
Step 5: Attach any relevant supporting documentation, such as product labeling or safety data sheets.
06
Step 6: Double-check all the entered information to ensure accuracy and completeness.
07
Step 7: Submit the completed extended EudraVigilance Medicinal Product form through the designated submission portal.

Who needs extended eudravigilance medicinal product?

01
Pharmaceutical companies manufacturing medicinal products that require pharmacovigilance activities.
02
Marketing authorization holders of medicinal products in the European Union.
03
Healthcare professionals involved in the reporting and monitoring of adverse drug reactions.
04
National competent authorities responsible for the regulation of medicinal products.
05
EudraVigilance, the European database for suspected adverse drug reactions.
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Extended EudraVigilance Medicinal Product is a system for collecting, managing, and analyzing information on the safety of medicines in the European Economic Area (EEA).
Marketing authorization holders (MAHs) are required to file extended EudraVigilance Medicinal Product.
Extended EudraVigilance Medicinal Product can be filled out using the EudraVigilance data entry tool.
The purpose of extended EudraVigilance Medicinal Product is to monitor and ensure the safety of medicines in the EEA.
Information such as suspected adverse reactions, batches of the product, and patient populations must be reported on extended EudraVigilance Medicinal Product.
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