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Extended EudraVigilance Medicinal Product Dictionary Training Course Two-day training course including hands-on exercises Key Topics General Terms and Definitions Registration in EudraVigilance and
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How to fill out extended eudravigilance medicinal product
How to fill out extended eudravigilance medicinal product:
01
Access the EudraVigilance website and log in to your account.
02
Click on the "Product Management" tab and select "Create a new medicinal product."
03
Fill in the required fields, such as the product name, dosage form, strength, and ATC code.
04
Enter the product's details, including the active substances, excipients, and the marketing authorization holder.
05
Provide information about the product's packaging, such as the container type, closure type, and packaging size.
06
Include any relevant information about the product's manufacturing, such as the manufacturer's name and address.
07
Upload any supporting documents, such as the product's summary of product characteristics or patient information leaflet.
08
Review the entered information for accuracy and completeness before submitting the form.
Who needs extended eudravigilance medicinal product:
01
Pharmaceutical companies and manufacturers who have obtained marketing authorization for medicinal products in the European Union.
02
Marketing authorization holders who need to comply with the pharmacovigilance requirements set by the European Medicines Agency (EMA).
03
Healthcare professionals involved in the surveillance and monitoring of adverse drug reactions and safety issues related to medicinal products.
04
Regulatory authorities and agencies responsible for the safety assessment and regulation of medicinal products within the European Union.
05
Patients and consumers who can report any adverse reactions or safety concerns regarding medicinal products to the relevant authorities through the EudraVigilance system.
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What is extended eudravigilance medicinal product?
Extended Eudravigilance Medicinal Product (xEVMPD) is a database that contains information on medicinal products for human use authorized in the European Union (EU).
Who is required to file extended eudravigilance medicinal product?
Marketing Authorization Holders (MAHs) are required to file extended eudravigilance medicinal product data for products authorized in the EU.
How to fill out extended eudravigilance medicinal product?
Extended eudravigilance medicinal product data can be filled out using the EVWEB system 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 ensure transparency and access to information on medicinal products authorized in the EU.
What information must be reported on extended eudravigilance medicinal product?
Information such as product name, active substance, dosage form, route of administration, marketing authorization number, and pharmaceutical form must be reported on extended eudravigilance medicinal product.
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