Questions and answers

What is xEVMPD data?

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.

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 ISO IDMP?

Data on medicines (ISO IDMP standards): Overview. The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use. Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

What is the EudraVigilance database?

EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy.

Where do I find SmPC?

Abbreviated as SmPC. More information can be found under ‘Product-information requirements’ and ‘Guideline on summary of product characteristics’.

What is the name of the public database which contains information on medicinal products in the EU?

As of July 2018, the European Medicines Agency (EMA) publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA). Marketing authorisation holders must submit and maintain this information in accordance with European Union (EU) legislation.

What are IDMP standards?

The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use. Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

How does EudraVigilance work?

EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.