Download Excel Data on EU Medicine Authorisations
Summary
EMA offers downloadable Excel data tables with detailed information on centrally authorised medicines, covering approved medicines, withdrawn marketing authorisation applications, post-authorisation procedure opinions, referrals, paediatric investigation plans, orphan designations, periodic safety update report single assessments (PSUSAs), direct healthcare professional communications (DHPCs), medicine supply shortages, herbal medicines, and medicines for use outside the EU. The website automatically updates these data tables overnight. Data includes information on medicines for which the European Commission has refused, suspended, or withdrawn a marketing authorisation.
About this source
GovPing monitors EMA Medicines - Full Catalogue for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 2 changes logged to date.
What changed
EMA provides downloadable Excel tables containing comprehensive regulatory data on EU medicines, including approved medicines, withdrawn applications, post-authorisation procedure opinions, referrals, paediatric investigation plans, orphan designations, PSUSAs, DHPCs, supply shortages, herbal medicines, and medicines for use outside the EU. The tables are publicly accessible and automatically updated overnight.
Healthcare professionals, pharmaceutical companies, patients, and regulatory researchers can use these tables to access structured data on medicine marketing authorisations, safety communications, and supply chain information. The data is informational and does not create new compliance obligations.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Download medicine data
You can download tables with detailed data on medicines from this page. This includes information on marketing authorisations of centrally authorised medicines and post-authorisation procedures. Human Veterinary Herbal Medicines
You can download data related to medicines published on EMA's website in table format. The website automatically updates these data tables overnight.
To stay up-to-date with new and updated information on this website, see:
Medicines
Find the following types of information on medicines in the table below:
- Approved medicines
- Withdrawn applications for new marketing authorisations
Status of opinions
Download medicines data table All relevant information and documents on medicines authorised at a European Union (EU) level are available on medicine pages. This includes:Full scientific assessment reports
Public-friendly overviews in question-and-answer format
Package leaflets
These pages also contain information on medicines for which the European Commission has refused a marketing authorisation, or has suspended or withdrawn the marketing authorisation after approval.
More up-to-date information on veterinary medicinal products is available on the Veterinary Medicines Information website.
For more information, see:
Post-authorisation procedures for medicines
Find information on opinions on post-authorisation procedures and withdrawn applications in the table below.
Download post-authorisation procedures for medicines data table During the post-authorisation stage of a medicine life-cycle, marketing authorisation holders can submit an application to change the terms of marketing authorisation. This is known as a variation.
At any stage of the assessment process, applicants can withdraw the application to EMA.
Information on approved post-authorisation procedures is available on medicine pages.
For more information, see:
Referrals
Find information on all ongoing and completed referrals in the table below.
Download referrals data table For more information, see:
Paediatric investigation plans
Find information on decisions related to paediatric investigation plans following evaluation from the Paediatric Committee (PDCO) in the table below.
Download paediatric investigation plans data table For more information, see:
Orphan designations
Find information on the status of orphan designations following assessment from the Committee for Orphan Medicinal Products (COMP) in the table below.
Download orphan designations data table For more information, see:
Periodic safety update report single assessments (PSUSAs)
Find information on the regulatory outcomes of periodic safety update report single assessments (PSUSAs) in the table below.
Download period safety update report single assessments data table Marketing authorisation holders periodically submit PSURs following a medicine's authorisation. EMA and national competent authorities carry out a single joint assessment of all medicines containing the same active substance or combination of active substances to determine if there is a need to update marketing authorisations.
For more information, see:
Direct healthcare professional communications (DHPCs)
Find information on direct healthcare professional communication (DHPCs) for human and veterinary medicines in the table below. These contain important new safety information about a medicine, including recommended actions that healthcare professionals should take.
Download direct healthcare professional communications data table For more information, see:
- Direct healthcare professional communications (DHPCs)
- Direct animal healthcare professional communications (DaHPCs)
Medicine supply shortages
Find information on ongoing and resolved medicine supply shortages assessed by EMA in the table below. The table includes links to individual shortage notices that contain valuable information for healthcare professionals and patients, along with details on the availability of alternatives.
Download medicine supply shortages data table For each shortage, additional information about the situation in a specific country may be available from the national competent authority.
For more information, see:
Herbal medicines
Find information on the status and outcomes of assessments from EMA's Committee on Herbal Medicinal Products (HMPC) in the table below.
Download herbal medicines data table For more information, see:
Medicines for use outside EU
Find information on the status of EMA's scientific opinions on high priority medicines for use outside of the EU in the table below.
Download medicines for use outside EU data table For more information, see:
Maximum residue limits (MRLs)
Find information on maximum residue limits (MRLs) in the table below.
Download maximum residue limits (MRLs) data table For more information, see:
- Maximum residue limits (MRLs) JSON data format files EMA’s entire website is available in JSON format for automated use. For medicines and related procedures, the data provided is identical to that provided in the tables on this page.
Page update history
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in April 2026.
See update history
10 April 2026
Maximum residue limits (MRLs) section added
Related documents
Product information URLs for member states
English (EN) (703 KB - XLS)
First published:
27/09/2018
Last updated:
22/04/2026
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