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Extended EudraVigilance Medicinal Product Dictionary (DEEMED) Live Virtual Training Course for Sponsors| COURSE DATES AND Telecourse # 22587 05 May 06 May2022 09:00 13:00 CEST Course # 22588 30 June

How to fill out extended eudravigilance medicinal product

How to fill out extended eudravigilance medicinal product

1. To fill out the extended eudravigilance medicinal product, follow these steps:
2. Access the eudravigilance website and log in to your account.
3. Navigate to the 'Medicinal Products' section.
4. Select the option to 'Add New Medicinal Product' or 'Edit Existing Medicinal Product'.
5. Provide all the necessary information about the product, including its name, ingredients, dosage forms, and strength.
6. Enter the manufacturing and batch details of the medicinal product.
7. Specify the indication and therapeutic areas for which the product is intended.
8. Include the product's unique identification code and any additional relevant codes.
9. Fill in all the mandatory fields and any other optional information as required.
10. Review the entered data for accuracy and completeness.
11. Save the completed form and submit it for further processing.
12. Wait for confirmation of successful submission or follow up on any additional requirements if necessary.

Who needs extended eudravigilance medicinal product?

1. Various entities and stakeholders involved in pharmacovigilance and drug safety need the extended eudravigilance medicinal product, including:
2. - Pharmaceutical companies that manufacture and distribute medicinal products in the European Union (EU).
3. - Regulatory authorities responsible for monitoring the safety and efficacy of drugs in the EU.
4. - Healthcare professionals who prescribe, dispense, or administer medicinal products.
5. - Marketing authorization holders (MAHs) of medicinal products.
6. - Clinical trial sponsors conducting studies in the EU.
7. - Pharmacovigilance service providers responsible for collecting and analyzing adverse drug reaction reports.
8. By using the extended eudravigilance medicinal product, these entities can ensure compliance with EU regulations, enhance drug safety monitoring, and contribute to the overall pharmacovigilance system.

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What is extended eudravigilance medicinal product?

Extended Eudravigilance Medicinal Product is a system for electronic reporting of suspected adverse reactions for medicinal products.

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 through the EudraVigilance system using a specific template.

What is the purpose of extended eudravigilance medicinal product?

The purpose of extended eudravigilance medicinal product is to monitor and report suspected adverse reactions to medicinal products for the safety of patients.

What information must be reported on extended eudravigilance medicinal product?

Information such as patient demographics, suspected adverse reaction details, and medical product information must be reported on extended eudravigilance medicinal product.