Which guidance of European Medicines Agency is referred for creation and updating product entries in EudraVigilance?

The European Medicines Agency (EMA) offers training on how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 database.

What is Article 57 pharmacovigilance?

All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date.

What is Xevmpd data?

xEVMPD or Extended EudraVigilance Medicinal Product Dictionary is a database (xEVMPD database) designed to support the collection, reporting, coding and evaluation of medicinal product data in a standardized and structured way.

What does Xevmpd mean?

XEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA) which defines controlled vocabulary to be used for the marketing authorisation of medicinal products. XEVMPD is a vocabulary to be used for the marketing authorisation of medicinal products.

What does evmpd stand for in medical category?

As such, the EVMPD was designed to support the collection, reporting, coding and evaluation of authorised and investigational medicinal product information in a standardised and structured way.

What is the EudraVigilance medicinal product Dictionary ( evmpd )?

EudraVigilance Medicinal Product Dictionary (EVMPD) The EVMPD has been developed by the European Medicines Agency in collaboration with the EudraVigilance implementation fora. The main objective of the EVMPD was to assist the pharmacovigilance activities in the European Economic Area (EEA).

What was the main objective of the evmpd?

The main objective of the EVMPD was to assist the pharmacovigilance activities in the European Economic Area (EEA). As such, the EVMPD was designed to support the collection, reporting, coding and evaluation of authorised and investigational medicinal product information in a standardised and structured way.

How to submit information to the European Medicines Agency?

Version 3.0 5 March 2012 20 March 2012 Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisa tion holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004 EMA/135580/2012 Page 2/184