Get the free EudraVigilance Registration Manual

1 October 2019EMA/536361/2019, Rev. 3 Information Management EMA EudraVigilance Registration ManualDomenico Scarlattilaan 6 Amsterdam 1083 HS The Netherlands +31 (0)800 781 6000 Telephone Send a question

How to fill out eudravigilance registration manual

How to fill out eudravigilance registration manual

1. To fill out the EudraVigilance registration manual, follow these steps:
2. Access the EudraVigilance website and navigate to the registration section.
3. Create an account if you don't have one already. Provide the required information and complete the registration process.
4. Login to your account using the credentials you set up during registration.
5. Once logged in, select the 'Registration' option from the menu.
6. Read the instructions carefully and gather all the necessary documents and information required for registration.
7. Start filling out the registration form by entering the requested details, such as personal/company information, contact details, and product information.
8. Keep in mind that some sections of the form may have specific requirements or restrictions. Ensure that you meet all the criteria to avoid any issues with the registration process.
9. Review all the entered information to ensure accuracy and completeness.
10. Submit the completed registration form.
11. After submission, you may be required to provide additional documentation or undergo further verification as per the EudraVigilance guidelines.
12. Wait for confirmation or feedback from EudraVigilance regarding the status of your registration.
13. Once your registration is approved, you will be able to access the EudraVigilance system and perform the necessary pharmacovigilance activities.

Who needs eudravigilance registration manual?

1. The EudraVigilance registration manual is needed by individuals or organizations involved in pharmacovigilance activities within the European Economic Area (EEA).
2. This includes pharmaceutical companies, clinical research organizations, regulatory authorities, healthcare professionals, and individuals responsible for the monitoring and reporting of adverse events related to medicinal products.
3. Anyone who wishes to submit and manage pharmacovigilance data through the EudraVigilance system needs to be familiar with the registration manual to ensure compliance with the guidelines and requirements set forth by EudraVigilance.

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What is eudravigilance registration manual?

Eudravigilance registration manual is a document containing guidelines and instructions on how to register and report adverse reactions to medicinal products within the European Union.

Who is required to file eudravigilance registration manual?

All stakeholders involved in the pharmaceutical industry, including marketing authorization holders, are required to file the eudravigilance registration manual.

How to fill out eudravigilance registration manual?

The eudravigilance registration manual can be filled out electronically on the EudraVigilance website following the guidelines provided in the manual.

What is the purpose of eudravigilance registration manual?

The purpose of the eudravigilance registration manual is to ensure standardized and efficient reporting of adverse reactions to medicinal products for the safety of patients.

What information must be reported on eudravigilance registration manual?

Information such as the description of the adverse reaction, patient demographics, concomitant medication, and reporter details must be reported on the eudravigilance registration manual.