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05 November 2014 EMA/623491/2014 Information and Communications Technology extended EudraVigilance Medicinal Product Dictionary (DEEMED) Bulk Update Manager User manual Version 1.0 30 Churchill Place
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How to fill out extended eudravigilance medicinal product
How to fill out extended eudravigilance medicinal product:
01
Start by gathering all the necessary information about the medicinal product. You will need the product's name, identification number, active ingredients, dosage form, and the manufacturer's details.
02
Access the eudravigilance system, which is the European database for reporting adverse reactions to medicines. To fill out the extended eudravigilance form, you need to have an account on the system.
03
Once you have logged in to the system, navigate to the section for reporting adverse reactions and select the option for extended eudravigilance reporting.
04
Begin by entering the basic details of the medicinal product, such as its name, identification number, and dosage form. Make sure to double-check the information for accuracy.
05
Provide comprehensive information about the adverse reaction that has been reported. This includes details about the patient, the reaction itself, and any accompanying medication or medical history that might be relevant.
06
Fill out sections related to the medical professional reporting the adverse reaction. Include their contact details, qualifications, and any additional comments they might have.
07
Review the entire form to ensure that all the required fields have been properly filled out. Take note of any potential errors or missing information before submitting the report.
Who needs extended eudravigilance medicinal product:
01
Pharmaceutical companies and manufacturers are required to complete the extended eudravigilance medicinal product report. This allows them to monitor the safety and effectiveness of their products and ensure compliance with regulatory requirements.
02
Healthcare professionals, including doctors, nurses, and pharmacists, may also need access to the extended eudravigilance medicinal product information. This enables them to stay informed about potential adverse reactions and provide the best possible care to their patients.
03
Regulatory agencies, such as the European Medicines Agency (EMA), rely on the extended eudravigilance medicinal product data to assess the safety profile of medicines and make informed decisions regarding their approval, labeling, and monitoring. This information is crucial for ensuring public health and patient safety.
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What is extended eudravigilance medicinal product?
Extended EudraVigilance Medicinal Product is a type of report that contains additional information beyond the standard EudraVigilance Medicinal Product.
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 following the specific guidelines provided by the European Medicines Agency (EMA).
What is the purpose of extended eudravigilance medicinal product?
The purpose of extended EudraVigilance Medicinal Product is to provide additional detailed information about medicinal products to enhance pharmacovigilance activities.
What information must be reported on extended eudravigilance medicinal product?
Information such as batch numbers, packaging information, and additional product characteristics must be reported on extended EudraVigilance Medicinal Product.
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