Get the free EXtended EudraVigilance Medicinal Product Dictionary

Extended EudraVigilance Medicinal Product Dictionary Training Course Two-day training course including Hanson exercises Course # 12168 78 June 2012 COMPUTER HELP, Prague, Czech Republic Key Topics

How to fill out extended eudravigilance medicinal product

How to fill out extended eudravigilance medicinal product:

1. Understand the purpose: Familiarize yourself with the concept of extended eudravigilance, which is a system designed for the electronic exchange of pharmacovigilance information in the European Union. It aims to promote the safety monitoring and reporting of medicinal products.
2. Access the system: Ensure you have the necessary access credentials to log in to the extended eudravigilance platform. If you don't have access yet, contact the relevant authority or your organization's responsible person for eudravigilance to obtain the required permissions.
3. Enter product details: Start by providing the essential information about the medicinal product, such as the name, strength, pharmaceutical form, route of administration, and its packaging details. Make sure to double-check the accuracy of these details before proceeding.
4. Specify the marketing authorization holder: Indicate the name of the company or organization holding the marketing authorization for the medicinal product in question. This serves to identify the responsible entity for the product's safety monitoring.
5. Record pharmacovigilance contact details: Include the contact information of the person or department responsible for pharmacovigilance activities related to the medicinal product. This ensures that relevant safety information can be communicated effectively.
6. Provide product-specific information: Fill out any additional mandatory fields specific to the medicinal product, such as the summary of product characteristics (SmPC), product reference information, batch numbers, and manufacturing details. These details aid in accurate identification and tracking of the product.
7. Document adverse reactions: As part of the extended eudravigilance process, report any known or suspected adverse reactions associated with the medicinal product. Ensure to include relevant details such as the nature of the reaction, the patient's age and sex, concomitant medications, and any known medical history.
8. Submit the form: Once you have completed all the necessary sections and reviewed the information, submit the filled-out extended eudravigilance medicinal product form. This will initiate the process of safety monitoring and reporting for the specified product.

Who needs extended eudravigilance medicinal product?

1. Pharmaceutical companies: Any company holding a marketing authorization for medicinal products within the European Union is required to comply with the extended eudravigilance system. This ensures that post-marketing safety monitoring is conducted effectively.
2. Regulatory authorities: National competent authorities responsible for the regulation of medicinal products rely on the extended eudravigilance system to gather and analyze safety data. This enables them to make informed decisions regarding the safety profile of different products.
3. Healthcare professionals: Extended eudravigilance provides healthcare professionals with a platform to report any adverse reactions they observe in patients. By documenting and sharing such information, they contribute to the ongoing assessment of medicinal product safety.

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What is extended eudravigilance medicinal product?

Extended Eudravigilance Medicinal Product is an enhanced system for monitoring the safety and effectiveness of medicinal products in the EU.

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 online through the EudraVigilance system.

What is the purpose of extended eudravigilance medicinal product?

The purpose of extended eudravigilance medicinal product is to improve pharmacovigilance and ensure the safety of medicinal products.

What information must be reported on extended eudravigilance medicinal product?

Information such as adverse reactions, suspected side effects, and changes in product composition must be reported on extended eudravigilance medicinal product.