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1 May 2014 EMA/207051/2014 Information and Communications TechnologyeXtended EudraVigilance Medicinal Product Dictionary (DEEMED) product export tool User manualVersion 1.0 Date of coming into force:
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How to fill out extended eudravigilance medicinal product
How to fill out extended eudravigilance medicinal product
01
To fill out the extended eudravigilance medicinal product, follow these steps:
02
Access the EudraVigilance website and login to your account.
03
Navigate to the 'Medicinal Products' section and select 'Extended EudraVigilance Medicinal Product'.
04
Fill in the required information for the product, such as the marketing authorization number, product name, and pharmaceutical form.
05
Provide details about the active substances, including their strength, route of administration, and Anatomical Therapeutic Chemical (ATC) code.
06
Enter information about the product's packaging, including the pack size, type, and shelf life.
07
Complete the sections related to the product's summary of product characteristics (SmPC), patient information leaflet (PIL), and product labelling.
08
Attach any necessary documentation, such as the product information file (PIF) or packaging artwork.
09
Review the entered information for accuracy and completeness.
10
Submit the completed extended eudravigilance medicinal product form for validation and approval.
11
Monitor the status of your submission on the EudraVigilance website.
Who needs extended eudravigilance medicinal product?
01
Any pharmaceutical company authorized to market medicinal products in the European Union (EU) needs the extended eudravigilance medicinal product. This requirement ensures the effective monitoring and reporting of adverse reactions associated with pharmaceutical products within the EU. Additionally, healthcare professionals, regulatory authorities, and patients benefit from the availability of comprehensive and standardized product information through this system.
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What is extended eudravigilance medicinal product?
Extended eudravigilance medicinal product refers to an enhanced system for the monitoring of the safety of medicines in the European Union.
Who is required to file extended eudravigilance medicinal product?
Marketing authorization holders 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 according to the guidelines provided by the European Medicines Agency.
What is the purpose of extended eudravigilance medicinal product?
The purpose of extended eudravigilance medicinal product is to enhance the post-marketing surveillance of medicines and ensure timely reporting of any adverse events.
What information must be reported on extended eudravigilance medicinal product?
Information such as suspected adverse reactions, medication errors, and any new safety information related to the medicinal product must be reported on extended eudravigilance medicinal product.
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