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25 May 2022 EMA/113700/2008Rev.2.1 Veterinary Medicines DivisionEudraVigilance Access Policy for Medicines for Veterinary Readopted by the Committee for Medicinal Products for19 April 2018Veterinary

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How to fill out eudravigilance access policy for

01

Go to the EudraVigilance website

02

Click on the 'Access Policy' section

03

Read through the instructions and guidelines for filling out the access policy form

04

Gather all the necessary information and documents required for the access policy

05

Fill out the access policy form accurately, providing all the requested information

06

Double-check the form to ensure all the information is correct and complete

07

Submit the access policy form online

08

Wait for the EudraVigilance team to review and process your access policy request

09

Once approved, you will receive the necessary access credentials and instructions to access EudraVigilance

Who needs eudravigilance access policy for?

01

Pharmaceutical companies

02

Regulatory authorities

03

Healthcare professionals

04

Clinical trial sponsors

05

Marketing authorization holders

06

Medical device manufacturers

07

Public health organizations

08

Research institutions

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Any entity involved in pharmacovigilance activities in the European Economic Area (EEA)

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What is eudravigilance access policy for?

Eudravigilance access policy is for ensuring secure access to the EudraVigilance database by authorized users.

Who is required to file eudravigilance access policy for?

Marketing Authorization Holders (MAHs) are required to file eudravigilance access policy.

How to fill out eudravigilance access policy for?

Eudravigilance access policy can be filled out online through the EudraVigilance system using the provided templates.

What is the purpose of eudravigilance access policy for?

The purpose of eudravigilance access policy is to ensure appropriate and secure access to the EudraVigilance database.

What information must be reported on eudravigilance access policy for?

Eudravigilance access policy must include information on access controls, user roles, and data protection measures.

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