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User DeclarationPart The undersigned PPV/RP/trusted Deputy User or Individual User declares that he/she will: keep the password provided by the European Medicines Agency for the access to EudraVigilance
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How to fill out eudravigilance user declaration for

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How to fill out eudravigilance user declaration for

01
Access the EudraVigilance website and login with your username and password.
02
Click on the 'User Declaration' tab on the dashboard.
03
Fill out all the required fields in the user declaration form, such as personal information, contact details, and professional qualifications.
04
Review the information entered carefully for accuracy.
05
Submit the user declaration form to complete the process.

Who needs eudravigilance user declaration for?

01
Any individual or organization involved in the development, manufacturing, distribution, or monitoring of medicinal products within the European Union may need to fill out a EudraVigilance user declaration.

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Eudravigilance user declaration is a formal document that allows organizations to access and utilize the EudraVigilance database, which is used for the monitoring of safety data related to medicinal products in the European Union.
Organizations involved in pharmacovigilance, such as pharmaceutical companies, contract research organizations, and regulatory authorities, are required to file the eudravigilance user declaration.
To fill out the eudravigilance user declaration, organizations must complete the designated form online, providing necessary details about their organization, intended use of the database, and any relevant contact information.
The purpose of the eudravigilance user declaration is to ensure that only qualified users can access safety data for medicinal products, thereby protecting patient safety and ensuring regulatory compliance.
The information that must be reported includes the organization's name, address, contact details, the nature of the work to be performed using the database, and any relevant personnel involved.
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