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9 paragraph 104. http //www. ema.europa.eu/ema/index. jsp curl pages/regulation/documentlisting/document listing000336. These are available from the office or on http //www. diahome. org/EUTerms Country Telephone Number email Required for confirmation Fax Number Date Signature. Jsp mid WC0b01ac05804d8b2b jsenabled true section7 http //ec.europa.eu/health/files/eudralex/vol-10/2011c17201/2011c17201en.pdf COURSE DATES 22-23 October 2015 15587 26-27 November 2015 15588 DAY ONE DAY TWO Review on...

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Step 1: Access the EudraVigilance system following the provided URL or login credentials.

02

Step 2: Navigate to the 'Medicinal Products' section within the system.

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Step 3: Locate the 'Extended EudraVigilance Medicinal Product' form.

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Who needs extended eudravigilance medicinal product?

01

Pharmaceutical companies manufacturing medicinal products and placing them on the market within the European Union (EU) need the extended EudraVigilance medicinal product.

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Marketing authorization holders (MAHs) who have obtained the necessary authorization to market their medicinal products also require the extended EudraVigilance medicinal product.

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Health authorities and regulatory bodies responsible for monitoring the safety and effectiveness of medicinal products in the EU may need access to the extended EudraVigilance system.

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Healthcare professionals, researchers, and individuals involved in pharmacovigilance and drug safety activities may benefit from using the extended EudraVigilance medicinal product.

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What is extended eudravigilance medicinal product?

Extended Eudravigilance Medicinal Product (EEMP) is an enhanced monitoring and reporting system for medicinal products in the European Union.

Who is required to file extended eudravigilance medicinal product?

Marketing Authorization Holders (MAHs) are required to file extended eudravigilance medicinal product.

How to fill out extended eudravigilance medicinal product?

Extended Eudravigilance Medicinal Product can be filled out electronically through the EudraVigilance system.

What is the purpose of extended eudravigilance medicinal product?

The purpose of extended eudravigilance medicinal product is to improve the monitoring and safety reporting of medicinal products.

What information must be reported on extended eudravigilance medicinal product?

Information such as adverse reactions, product defects, and other safety-related data must be reported on extended eudravigilance medicinal product.

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