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Extended EudraVigilance Medicinal Product Dictionary Facetoface training course # 19582 1920 September 2019 BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The NetherlandsOVERVIEW The submission

How to fill out extended eudravigilance

How to fill out extended eudravigilance

1. To fill out the extended eudravigilance form, follow these steps: 1. Obtain access to the eudravigilance system by registering as a user.
2. Log in to the eudravigilance portal using your credentials.
3. Navigate to the 'Extended EudraVigilance Medicinal Product Report (XEVPRM)' section.
4. Provide the required information in each section of the form, such as the product's identification details, adverse event description, and patient information.
5. Complete the case narrative by including a clear description of the adverse event, relevant medical history, and any concomitant medications.
6. Upload any supporting documentation, such as lab results or medical records, if applicable.
7. Review the filled-out form for accuracy and completeness.
8. Submit the form electronically by clicking on the 'Submit' button.
9. Await confirmation of submission and follow any additional instructions provided by the eudravigilance system.

Who needs extended eudravigilance?

1. Extended eudravigilance is required by pharmaceutical companies, marketing authorization holders, and other stakeholders involved in the development, manufacturing, and distribution of medicinal products within the European Union.
2. These entities need to report any adverse events, suspected adverse reactions, or other safety concerns related to their products to ensure patient safety and comply with regulatory requirements.
3. It is also important for pharmacovigilance authorities and regulatory bodies to have access to this information for monitoring the safety, efficacy, and risk-benefit balance of medicinal products on the market.

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What is extended eudravigilance?

Extended Eudravigilance is an evolved version of Eudravigilance, a system used for the electronic exchange of safety information on medicines in the EU.

Who is required to file extended eudravigilance?

Marketing authorization holders (MAHs) are required to file extended eudravigilance.

How to fill out extended eudravigilance?

Extended Eudravigilance can be filled out using the EU's EudraVigilance system according to the guidelines provided by the European Medicines Agency (EMA).

What is the purpose of extended eudravigilance?

The purpose of extended eudravigilance is to monitor and ensure the safety of medicines in the EU market by collecting and analyzing information on adverse reactions.

What information must be reported on extended eudravigilance?

Information on suspected adverse reactions, medication errors, off-label use, and unexpected benefits of medicines must be reported on extended eudravigilance.