Get the free EudraVigilance Access Policy for Medicines for Veterinary Use
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330 April 2018
EMA/113700/2008 Rev.1
Veterinary Medicines and Product Data Management4EudraVigilance Access Policy for Medicines for Veterinary UseEudraVigilance Access Policy for Medicines for
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How to fill out eudravigilance access policy for
How to fill out eudravigilance access policy for
01
To fill out the Eudravigilance access policy, follow these steps:
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Login to the Eudravigilance portal using your credentials.
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Navigate to the 'Access Policy' section.
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Click on the 'Fill out Access Policy' button.
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Read and understand the instructions provided.
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Provide all the necessary information accurately.
07
Review the filled-out policy for any errors or missing details.
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Submit the access policy form.
09
Wait for the confirmation of your access policy submission.
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Note: It is recommended to consult any specific guidance or documentation provided by the Eudravigilance authority for accurate policy filling.
Who needs eudravigilance access policy for?
01
Eudravigilance access policy is required for individuals or organizations involved in pharmacovigilance activities within the European Union.
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This includes but is not limited to:
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- Pharmaceutical companies manufacturing or distributing medicinal products in the EU.
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- Regulatory authorities responsible for monitoring and overseeing drug safety.
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- Healthcare professionals reporting adverse drug reactions.
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- Clinical trial sponsors conducting trials in the EU.
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- Research institutions collecting and analyzing safety data.
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The access policy ensures compliance with the EU pharmacovigilance regulations and allows authorized individuals to access and contribute to the Eudravigilance database.
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What is eudravigilance access policy for?
The eudravigilance access policy is designed to ensure secure access to the EudraVigilance database for authorized users.
Who is required to file eudravigilance access policy for?
Marketing authorization holders (MAHs) are required to file the eudravigilance access policy.
How to fill out eudravigilance access policy for?
The eudravigilance access policy can be filled out online through the EudraVigilance system.
What is the purpose of eudravigilance access policy for?
The purpose of the eudravigilance access policy is to ensure that only authorized users have access to sensitive pharmacovigilance data.
What information must be reported on eudravigilance access policy for?
The eudravigilance access policy must include information on the procedures for granting and revoking access to the EudraVigilance database.
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