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SummaryThe public drug databases of the European Union are a set of separate registers, each created by a different piece of legislation and each answering one narrow question: who is authorised to manufacture, import or distribute a medicine (EudraGMDP), which products hold a central marketing authorisation (the Union Register), what a medicine is as structured data (the Article 57 database and SPOR/IDMP), what has been reported about its safety (EudraVigilance), which trials are running (CTIS), and where supply is disrupted (the shortages catalogue). There is no single European drug database, and treating the collection as one is the most common mistake teams make when they start working with EU pharmaceutical data.
This article takes the regulatory and infrastructure view of pharmaceutical databases: what the EU actually publishes, under which legal basis, who enters the data, and where each register stops being reliable. It deliberately does not cover the commercial and clinical drug database market, which is a different subject with a different set of vendors.
Each register exists because a specific legal article required it, and each article had a specific purpose. EudraGMDP exists because Directive 2001/83/EC obliged the Union to publish authorisation and certificate data. The Article 57 database exists because Regulation (EC) No 726/2004 obliged marketing authorisation holders to submit product information electronically. CTIS exists because Regulation (EU) 536/2014 replaced the old clinical trials directive.
The consequence is structural, not accidental. The registers were never designed to join to each other. They use different identifiers, different update cycles and different definitions of the same object. A medicine in the Union Register is a marketing authorisation. The same medicine in the Article 57 database is a set of authorised presentations. In a national article file it is a set of packs with national article numbers. These are three different granularities of the same thing, and nothing in the public infrastructure maps between them for you.
EudraGMDP is the Union database of manufacturing and import authorisations, wholesale distribution authorisations, GMP and GDP certificates, statements of non-compliance, and registrations of active-substance manufacturers, importers and distributors located in the EEA. It is operated by the European Medicines Agency on behalf of the Union, but the content is entered by the national competent authorities of the Member States.
The legal basis is Directive 2001/83/EC as amended: Article 40(4) for manufacturing and import authorisations, Article 77(4) for wholesale distribution authorisations, and Article 111(6) for the Union database itself. The EudraGMDP welcome page names Article 111(6) explicitly, and also Article 91 of Regulation (EU) 2019/6 for the veterinary side. A public version has been available since 2011.
For anyone doing partner due diligence, supplier qualification or market-entry research, EudraGMDP is the primary source. It answers questions no commercial dataset answers as authoritatively: does this contract manufacturer hold a valid authorisation, is this wholesaler licensed for the scope it claims, has this site received a statement of non-compliance.
The register is unusually honest about its own limits, and those limits matter. Three of them are stated by EMA itself.
"EMA is not responsible for the contents of the database. Any questions on its content should be addressed to the relevant National Competent Authority." (European Medicines Agency, EudraGMDP welcome page)
To that official list, one practitioner observation is worth adding, and it should be read as an observation from working with the register rather than as an official acknowledgement: there is no full-text search that spans the registers, and no documented public bulk export or API. Anything resembling systematic analysis has to be assembled record by record. There is also entry lag, because Member States upload data as it becomes available rather than on a fixed schedule.
The Union Register of medicinal products, maintained by the European Commission, is the authoritative list of products holding a centrally authorised marketing authorisation valid across the EU. It carries the decision history: the original authorisation decision, subsequent variations, extensions, suspensions and withdrawals, with dates.
The Union Register and the EMA medicines pages are complementary rather than duplicative. The Commission register is the legal record of the decision. The EMA medicine page carries the scientific documentation, above all the European Public Assessment Report (EPAR), plus the product information in all official languages. If you need the legal status of an authorisation, use the register. If you need the assessment rationale or the current SmPC, use EMA.
Note the scope limit that catches people out. Centrally authorised products are a minority of the medicines on any European market. Nationally authorised products, which include most generics, appear in national registers only.
The Article 57 database is the EU repository of structured product data submitted by marketing authorisation holders, required under Article 57(2) of Regulation (EC) No 726/2004; submission has been mandatory for all human medicines authorised in the EEA since July 2012. It is implemented through the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
This is the register that shifts pharmaceutical information from documents to data. An SmPC is a document meant to be read. An Article 57 record is a set of fields meant to be queried: authorisation holder, authorisation number and country, active substances, strengths, pharmaceutical form, route of administration.
SPOR is the successor programme, built to implement the ISO IDMP standards. It has four master data services:
| Service | Full name | What it standardises |
|---|---|---|
| OMS | Organisation Management Service | Organisations: authorisation holders, sponsors, manufacturing sites, with a single identifier per organisation |
| RMS | Referentials Management Service | Controlled vocabularies: dose forms, routes of administration, units of measurement |
| SMS | Substance Management Service | Substances, from active moiety to specified substance |
| PMS | Product Management Service | Products, both authorised and investigational, as structured records |
The EMA overview of ISO IDMP standards is the entry point. The practical point for data teams is that OMS and RMS are usable now and worth adopting early, because they give you stable identifiers for organisations and controlled terms that will not drift. PMS is the piece that will eventually make cross-register joins realistic, and it is the piece still being rolled out.
EudraVigilance is the EU system for reporting and evaluating suspected adverse reactions, and its public face is adrreports.eu, which publishes aggregated suspected-adverse-reaction data by active substance or centrally authorised product. The public portal is aggregate by design. It shows counts of reports, not case narratives, and a suspected adverse reaction report is not evidence that the medicine caused the event. Treating adrreports.eu counts as an incidence rate is a serious misreading, and one that appears regularly in secondary reporting.
For clinical trials, the Clinical Trials Information System (CTIS) is the system of record under Regulation (EU) 536/2014. Its public website went live on 31 January 2022. The older EudraCT register still holds historical records and remains useful for retrospective work, but it no longer serves as the system of record for ongoing trials.
The EMA shortages catalogue lists supply shortages that have been assessed at EU level, which is a much narrower set than the shortages actually affecting any given national market. EU-level assessment applies where a shortage affects more than one Member State or concerns a centrally authorised product, or where a coordinated response is needed.
Day to day shortages are national. In Germany they sit in the BfArM register, in other Member States in the equivalent national register, each with its own reporting duty, its own fields and its own definition of what counts as a shortage. Anyone tracking supply across borders is reconciling roughly thirty national sources against one European catalogue, and the identifiers do not match.
The EU registers describe authorisations, substances and safety. They do not describe markets. Nothing in the European public infrastructure tells you what a medicine costs, whether it is reimbursed, which pack sizes are on sale, what the national article number is, or whether a wholesaler can deliver it this week. Those facts live in national systems, and they are the facts most operational questions actually turn on.
A worked example makes the boundary concrete. Suppose you need to know whether a specific generic is available in Germany, at what price, and in which pack sizes. The Union Register will not help, because the product is nationally authorised rather than centrally. The Article 57 record will confirm the authorised presentations but says nothing about price or availability. EudraGMDP will confirm that the manufacturer holds a valid authorisation, which is a different question again. The answer sits in German article and pricing data, and the EU registers only tell you that the product legitimately exists.
The reverse is also true and is the reason the EU layer matters. National data is complete about its own market and blind outside it. If the question is whether a comparable product is authorised in another Member State, or whether a supplier in a third country is inspected, no national article file answers it.
So the practical model is a two-layer one. Use the EU registers for existence, legality and identity. Use national data for commerce, logistics and availability. Most serious data errors in this field come from asking one layer a question that only the other layer can answer.
| Register | Owner | Legal basis | Best used for |
|---|---|---|---|
| EudraGMDP | EMA, data from national authorities | Directive 2001/83/EC Art. 40(4), 77(4), 111(6) | Verifying manufacturing, import and wholesale authorisations and GMP/GDP status |
| Union Register | European Commission | Regulation (EC) No 726/2004 | Legal status and decision history of centrally authorised products |
| EMA medicines and EPARs | EMA | Regulation (EC) No 726/2004 | Assessment rationale, product information, indication wording |
| Article 57 / XEVMPD | EMA | Regulation (EC) No 726/2004 Art. 57(2) | Structured product data submitted by authorisation holders |
| SPOR (OMS, RMS, SMS, PMS) | EMA | ISO IDMP implementation programme | Master data and stable identifiers for organisations, terms, substances, products |
| EudraVigilance / adrreports.eu | EMA | EU pharmacovigilance legislation | Aggregated suspected adverse reaction reports |
| CTIS | EMA | Regulation (EU) 536/2014 | Clinical trial applications and results in the EU |
| EMA shortages catalogue | EMA | EU shortage coordination | Shortages assessed at EU level |
Three habits separate teams that get value from these registers from teams that get frustrated by them.
The reconciliation work is where most of the effort goes, and it is why commercial platforms exist alongside the public registers rather than in competition with them. The public registers are authoritative but unjoined. For questions that cross a register boundary or a national border, for example finding an authorised equivalent in another market when a product is unavailable at home, pharmazie.com bundles all three data layers, clinical, commercial and logistical, together with international product data across 50+ countries and 25+ databases, into a single search, whereas the public registers and most commercial sources each cover only one slice of that picture. Entry-level access starts from EUR 135/month (see pharmazie.com pricing), whereas most other providers communicate no public list price. For a single authoritative fact about one authorisation, go to the register itself.
This content is intended for healthcare professionals and does not constitute medical advice. Last reviewed: July 2026.
