article 57 database xevmpd

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A Step-by-Step Guide to Using Academic Databases for Research

In the digital age, academic databases have become essential tools for researchers and students alike. With vast collections of scholarly articles, books, and other resources, these databases provide a wealth of information on various subjects. However, navigating these databases can be overwhelming for those unfamiliar with their functionalities. In this step-by-step guide, we will walk you through the process of using academic databases effectively for your research needs.

Understanding Academic Databases

Before delving into the practical aspects of using academic databases, it’s crucial to understand what they are and how they differ from other sources of information. Academic databases are online platforms that host scholarly content such as journal articles, conference papers, dissertations, and more. Unlike search engines like Google or Wikipedia, which prioritize popular or general content, academic databases focus on peer-reviewed research conducted by experts in their respective fields.

These databases usually require a subscription or access through an institutional affiliation like a university or library. By restricting access to authenticated users only, they ensure the quality and reliability of the content available. Some well-known academic databases include JSTOR, ScienceDirect, PubMed, IEEE Xplore, and ACM Digital Library.

Selecting the Right Database

With numerous academic databases available today, it’s essential to choose the most appropriate one for your research topic. Each database specializes in certain disciplines or subject areas; therefore, selecting a database that aligns with your research interest is paramount.

Start by identifying keywords related to your research topic. These keywords will help you narrow down your search when exploring different databases’ offerings. For example, if you’re researching climate change impacts on biodiversity conservation strategies in marine ecosystems, relevant keywords could include “climate change,” “biodiversity conservation,” “marine ecosystems,” and so on.

Once you have identified your keywords and subject area(s), consult with librarians or experienced researchers who can guide you in selecting the most relevant databases. They can suggest databases that specialize in your field or those that cover a broader range of disciplines.

Conducting Effective Searches

After selecting the appropriate academic database(s), it’s time to conduct effective searches to find the information you need. Most databases offer advanced search options, allowing users to refine their queries and obtain more accurate results.

Start by entering your keywords into the search bar. To enhance your search results, consider using Boolean operators such as “AND,” “OR,” and “NOT” to combine or exclude specific terms. For example, using “climate change AND biodiversity conservation” will retrieve articles that contain both terms, while “climate change NOT marine ecosystems” will exclude articles related to marine ecosystems from your results.

Additionally, take advantage of filters and limiters provided by the database. These options allow you to narrow down your search based on publication date, author, journal name, and other criteria. Utilizing these features will help you focus on the most recent and relevant research within your field.

Evaluating and Accessing Sources

Once you have obtained a list of potentially relevant sources from your search, it’s essential to evaluate their quality before incorporating them into your research. Academic databases often provide information about each source’s credibility by displaying metrics such as citation counts, impact factors, and peer review status.

Consider factors such as the author’s expertise and affiliations, publication date (preferably recent), journal reputation (if applicable), and relevance to your research question when assessing sources. Additionally, check for any potential biases or conflicts of interest that may affect the objectivity of the research findings.

After evaluating sources for their suitability and reliability, access them through the database’s provided links or follow instructions for accessing full-text versions if available. Some articles may be openly accessible while others may require additional permissions or subscriptions.

In conclusion, academic databases are invaluable resources for researchers seeking reliable and up-to-date information. By understanding the basics of academic databases, selecting the right database(s) for your research, conducting effective searches, and evaluating and accessing sources, you can maximize the benefits these platforms offer. So, dive into the world of academic databases and unlock a treasure trove of knowledge for your research endeavors.

This text was generated using a large language model, and select text has been reviewed and moderated for purposes such as readability.

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Data submission on authorised medicines (Article 57)

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. This is a legally binding requirement from the EU pharmaceutical legislation. The Agency uses this information to support the analysis of data, regulatory activities and communication.

The aim of the submission of data is to establish a complete inventory of all medicines authorised for use in the EU and EEA, including medicines authorised centrally via the EMA and those authorised at national level.

The Agency uses this information for a range of purposes. These include:

• analysis of data in EudraVigilance and signal management ;
• reporting and coding of individual case safety reports ;
• data analytics and business intelligence;
• coordination of regulatory actions to safeguard public health, including referral procedures, establishment of a repository of periodic safety update reports (PSURs) and literature monitoring;
• supporting the calculation of fees for pharmacovigilance ;
• establishing the European medicines web portal;
• publishing a complete list of all medicines authorised in the EEA with contact details for pharmacovigilance enquiries;
• granting proactive and reactive access to EudraVigilance data;
• exchanging data within the EU and internationally;
• supporting communication between the Pharmacovigilance Risk Assessment Committee ( PRAC ) and marketing-authorisation holders.

Legal background

The submission of data on medicines by marketing-authorisation holders is a legal requirement from the 2010 pharmacovigilance legislation .

Marketing-authorisation holders were initially required to submit information on medicinal products for human use to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format by 2 July 2012.

Since July 2012, marketing-authorisation holders are required to submit information on new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the national competent authority .

By 31 December 2014 marketing-authorisation holders were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additionally required information.

Information on amendments to the terms of marketing authorisations following variation , transfer, renewal , suspension, revocation or withdrawal shall be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised.

Working with the pharmaceutical industry

The Agency is working closely with the European pharmaceutical-industry associations on the implementation of these measures.

The Agency hosts meetings of the Joint Implementation Working Group (IWG) with representatives from EU industry associations to address practical questions on data-submission requirements. These meetings cover aspects related to planning and the submission process.

Topics endorsed at the IWG include:

• definition of the processes and timeline for post-authorisation maintenance submission due to variations , extensions of the terms of marketing authorisations and transfers of marketing authorisations ;
• definition of the processes and timeline for maintenance of pharmacovigilance information on the qualified person for pharmacovigilance , pharmacovigilance enquiry details and the location of the pharmacovigilance system master file;
• definition of processes and timeline for handling suspensions, lifting of suspensions, revocations and withdrawals of marketing authorisations ;
• definition of technical aspects related to the implementation of additional information on medicines required to be submitted during the 'transition maintenance phase' for the Agency to support new legal obligations;
• definitions of business requirements to develop a new functionality to enable the export of medicinal product data from the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) by industry to facilitate the data-quality revision and improvement.

More information

• Reporting requirements for marketing-authorisation holders
• How to submit information
• Guidance documents
• Registration
• Training and best practice
• Public data from Article 57 database

Related documents

Transition plan from article 57 and xevmpd data submission to spor (pdf/110.07 kb).

First published: 01/12/2016 Last updated: 01/12/2016 EMA/492403/2016

Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004 (PDF/214.07 KB)

First published: 17/02/2015 Last updated: 23/02/2015 EMA/471367/2014 Rev. 1

Related content

• Pharmacovigilance
• EudraVigilance
• Data on medicines (ISO IDMP standards)
• Substance, product, organisation and referential (SPOR) master data
• Information management

Related EU legislation

• Regulation (EC) No 726/2004
• Regulation (EU) No 1235/2010

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4. EudraVigilance

1. EudraVigilance

1.4. the eudravigilance database containing “article 57 database”.

The submission of data on medicines by MAHs is a legal requirement from the 2010 pharmacovigilance legislation . Data in EudraVigilance is submitted electronically by NCAs and by pharmaceutical companies that hold the marketing authorisation for medicines. The aim is to establish a complete inventory of all medicines authorised for use in the EU and EEA , including both, centrally authorised medicines via the EMA and those authorised at national level. MAHs are required to submit information on their medicines to the Article 57 database in accordance with Article 57(2) of Regulation (EC) No. 726/2004 .

The EMA uses this information for:

• analysis of data in EudraVigilance and signal management;
• reporting and coding of individual case safety reports;
• facilitating medicines regulation and fulfilling regulatory actions and legal obligations;
• and strengthening communication with stakeholders.

EMA publishes information on all authorised medicines contained in the Article 57 database in the form of an excel document.

The document contains the following data fields:

• product name (product short name: brand name or the combination of the generic name and the company name);
• active substance ;
• route of administration ;
• country of authorisation;
• name of the marketing authorisation holder (company);
• country of location of the pharmacovigilance system master file;
• marketing authorisation holder 's contact email address and telephone number for pharmacovigilance enquiries.

Only products that have a valid marketing authorisation are included in the document and EMA updates this document periodically to reflect changes in the Article 57 database.

Below the link to an example for this information:

Article 57 product data (XLSX/7.31 MB) (updated)

First published: 30/07/2018 Last updated: 02/06/2021 EMA/518502/2018 Rev. 35

The EudraVigilance database holds over 16 million Individual Case Safety Reports (ICSRs) referring to over 9 million cases and is one of the largest pharmacovigilance databases in the world. Enhanced functionalities, following significant recent development, allow for a better support of pharmacovigilance activities and the protection of public health. In other jurisdictions similar approaches exist.

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Article 57 fact sheet

• Electronic submission of medicinal product information by marketing authorisation holders

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EMA publishes list of contact details for pharmacovigilance enquiries

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The European Medicines Agency, EMA, published information on all authorized medicines contained in the Article 57 database in the form of an Excel® document entitled Article 57 product data . Marketing authorization holders are required to submit information on their medicines to the Article 57 database in accordance with Regulation (EC) No. 726/2004 .

Post-authorization data on medicines ( ISO IDMP standards ): All holders of marketing authorizations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the EMA on authorized medicines via the extended EudraVigilance medicinal product dictionary ( xEVMPD ), also known as Article 57 database, and keep this information up-to-date. EMA says " this is aimed at ensuring the quality of data in the xEVMPD on authorized or investigational medicinal products " (IMPs).

As of July 2018 EMA publishes extracted data from the Article 57 database on all medicines authorized in the EEA. Marketing authorization holders (MAHs) must submit and maintain this information in accordance with EU legislation. According to the agency, " the primary objective of making this information public is to provide a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries" . It also aims to enable marketing authorization applicants to better assess their potential invented names and facilitate the activities of the (Invented) Name Review Group which assesses whether a proposed invented name could create a public health concern or potential safety risk. In addition, it is a legal requirement for the EMA to publish contact details for pharmacovigilance enquiries and of the location of the pharmacovigilance system master file (PSMF).

The file currently contains the following data (only products that have a valid marketing authorization are included in the document):

• product name (product short name, brand name or the concatenation of the generic name and the company name);
• active substance;
• route of administration;
• country of authorization;
• name of the MAH (company);
• country of location of the PSMF ;
• MAH´s  contact e-mail address and telephone number for pharmacovigilance enquiries .

The EMA will update this Excel file periodically to reflect changes in the Article 57 database.

Register for the new Drug Safety/Pharmacovigilance Newsletter and find out what the latest trends are.

Excel is a registered trademark of Microsoft Corp .

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Xevmpd won’t be updated.

Confirmed: No support for Chrome or other browsers planned

Martti Ahtola | Dec 16, 2022

The termination of Internet Explorer

We have written this year about EMA’s product information system for medicinal products, XEVMPD, and its lack of support of current day web browsers such as Chrome, Mozilla, Edge and Safari. The system can be only used with Internet Explorer (IE) which was by itself already annoying but became a real challenge for all European regulatory affairs professionals in July 2022 when Internet Explorer was terminated .

During the past summer EMA introduced IE Tab extension for modern browsers as a solution. Users of XEVMPD are able to acquire a license for IE Tab from the EudraVigilance page and the software license is paid by EMA. The extension emulates old versions of Internet Explorer software and according to the developer of the extension it can be used for Java, Silverlight and ActiveX.

When will Chrome or other browsers be supported?

Some time ago, we received a question from a reader of the Tepsivo blog asking when modern browsers would be supported by XEVMPD. As EMA had not communicated anything related to timelines or details about this particular matter we did not have any idea of when that could be. To find out more, we contacted the EMA through the official communication pathway.

To give some background information, it turned out that our reader was in a situation where Internet Explorer was no longer available but installing an extension to a browser was not that simple. Many life science organizations and corporations in general restrict what their users can install on their computers and there are organizations that even restrict what sites the users can access through their browser using the company network. Executable files and browser extensions are known safety risks , so it is understandable. Life science and healthcare organizations tend to be particularly careful with staff of varying IT skills handling sensitive information.

In the current situation with XEVMPD, the IT departments of pharmaceutical companies and other healthcare organizations have to customize or configure user setups for the regulatory team members who are responsible for updating or monitoring medicinal product information in the XEVMPD.

There will be no update

The response we received from the EMA was the following:

“The XEVMPD/Article57 user interface (EVWEB) can only be accessed using an IE Tab extension in Google Chrome or Microsoft Edge. There are no plans to change the platform as XEVMPD submissions will be replaced with PMS submissions in the future. PMS UI will be built taking into account those limitations and using current browsers.”

This answers the question partially: XEVMPD will never be updated to support Chrome, Safari or Mozilla but there will be a time when the regulatory affairs experts submitting marketing authorization applications, updating the product information or contact details related to the organization responsible for the products will be able to perform these tasks no matter what browser they are using. But we do not know when that time will be.

EMA has not published any updates since July 2022 related to the implementation of Product Data Management Services (PMS). As we have described in our comprehensive description of IDMP , the first iteration of the PMS is planned to cover a subset of the authorized medicinal product part of the ISO IDMP standards and the new ISO IDMP compatible data submission format ( HL7 FHIR ) replaces the current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM).

In 2022, EMA has focused on replacing the current .pdf based electronic application and variation forms (eAF) by web-based forms as part of DADI project and improving the technical components needed to reflect authorized data in the PMS. PMS is linked to the electronic variation forms because it provides the product data for these.

Importantly for the timeline of delivering a new product information management system and finally ending the era of playing around with Internet Explorer emulations, EMA is still deciding on some aspects of the PMS implementation.

These include:

• “whether it is still relevant to follow a two-step approach (CAP & Fast Healthcare Interoperability Resources (FHIR) message first; non-CAPs second) and how this impacts the process described in the EU Implementation Guide’s (EU IG) chapter 3;
• whether replacing the Art 57 data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the new ISO IDMP compatible format (HL7 FHIR) takes place only after all relevant application forms are released by the Digital Application Dataset Integration (DADI) project.”

Especially the latter seems to be relevant for the timeline. DADI variation forms project timeline is by the end of Q4 2023. If EMA decides to wait until the end of the DADI forms, which now have a new name (and abbreviation, of course): Product Lifecycle Management (PLM) Portal , it means that at least one part of PMS implementation would start earliest in 2024.

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Managing XEVMPD (Article 57) submissions

Qdossier has created and maintained 6K+ authorised products in XEVMPD since 2011. Our data stewards support in data collection, extractions, cleansing, transformation and entry. Due to our experience in Product- and registration tracking and submission management, we have a comprehensive understanding of regulatory activities and related processes. 

Data management services

We offer a one-stop-shop and can provide EMA certified human resources, take care of data extraction, prepare submissions, submit updates to the European Medicines Agency (EMA). Furthermore, upon receipt of third acknowledgement messages, our staff can address EMA QC findings, define follow-up actions and manage updates of records and supportive document, as appropriate. We are software independent and can work with both EVWEB and any vendor solution. Alternatively we can host your XEVMPD data and take care of the submissions using our in-house tool. Our data stewards can align internal records and databases with EVWEB data to synchronize the current view on data present at both the European Medicines Agency (EMA) and the Company. We can also share our expertise through training and workshops

XEVMPD Software as a Service

Qdossier offers a highly secured SAAS environment to manage your XEVMPD submissions, either as an intermediate solution or for a longer period of time. A client specific working environment can be rapidly deployed and is accessible via a secure two-way authentication process from any location that has an internet connection. Affiliates and partners can be provided with system access to review and approve the XEVMPD output created by your own staff or the Qdossier team. Standard operating procedures and training materials are available to support the entire process of data management and submissions.

Article 57 Background

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. This is a legally binding requirement from the EU pharmaceutical legislation. The Agency uses this information to support the analysis of data, regulatory activities and communication.

The aim of the submission of data is to establish a complete inventory of all medicines authorised for use in the EU and EEA, including medicines authorised centrally via the EMA and those authorised at national level. More information can be found on the  EMA website .

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Qdossier writers have the skill set to provide the information in an unambiguous way; meaning that factual information will often be provided in tabular formats and bulleted lists, rather than narratives.

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eXtended EudraVigilance Medicinal Product Dictionary training course

Virtual training course on how to submit and retrieve medicinal product data using EVWEB/ XEVMPD (Art 57 database) for authorised as well investigational medicinal products.

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