EU Drug Authorization Database: The Complete Guide

An EU drug authorization database is a public register that records which medicinal products hold a valid marketing authorisation in the European Union, who holds it, and on what terms. There is no single database that covers all of them: centrally authorised products sit in the EMA medicines database and the European Commission's Union Register, while nationally authorised products sit in 27 separate national registers plus the HMA MRI Product Index for mutual recognition and decentralised procedures.

That last sentence is the part most reference articles skip, and it is the part that costs regulatory affairs teams, hospital pharmacies, wholesalers and market access analysts real working hours. The authorisation layer in Europe is deliberately federated. Understanding which register answers which question is the difference between a five minute check and a two day reconstruction.

Which EU drug authorization databases exist?

Seven public systems carry the bulk of EU authorisation and product master data, and each was built for a different purpose. The table below maps them to the question each one actually answers.

What is the EMA medicines database and what does it hold?

The EMA medicines database is the agency's public catalogue of every human and veterinary medicine that has been through a centralised EU procedure. For each entry it publishes the European Public Assessment Report (EPAR), the current summary of product characteristics (SmPC), the package leaflet, the labelling text, and the procedural history including variations and referrals.

Its scope is defined by procedure, not by therapeutic importance. The centralised procedure is mandatory for biotechnology derived medicines, advanced therapies, orphan medicines, and products for HIV, cancer, diabetes, autoimmune disease, neurodegenerative disease and viral disease. Everything else may go centrally, but usually does not.

Volume gives a sense of the annual inflow. According to the EMA's human medicines highlights for 2025, the agency recommended 104 medicines for marketing authorisation that year, of which 38 contained a new active substance never before authorised in the European Union, alongside 41 recommendations for new biosimilars, the highest annual biosimilar figure recorded to date. Those hundred or so products join a centrally authorised catalogue that remains a minority of the medicines actually dispensed in any member state.

What is the Union Register of medicinal products?

The Union Register of medicinal products is the European Commission's legal record of centrally authorised products. Where the EMA database is the scientific and documentary view, the Union Register is the administrative one: it reflects the Commission decision that actually grants, varies, suspends or withdraws the authorisation.

Each entry carries the product name, the EU registration number, the marketing authorisation holder with address, the active substance, the international nonproprietary name (INN), the ATC code, the therapeutic indication and the associated legal documents. Critically, the register also retains products whose authorisation was suspended, withdrawn or refused. For anyone reconstructing why a product disappeared from a market, that historical layer is the primary source.

The practical rule: use the EMA database for what the medicine does and how it was assessed, and the Union Register for what its legal status is on a given date.

Why is there no single EU register of all authorised medicines?

Because most medicines in Europe are not authorised by the EU. They are authorised by member states. A generic paracetamol tablet, a decades old cardiovascular product, a locally packaged antibiotic: these are national authorisations, granted by a national competent authority, listed only in that country's register.

The EMA maintains a directory of national registers of authorised medicines, but it is a list of links, not a merged dataset. Each register has its own language, its own search logic, its own update rhythm, its own export options and, in several cases, no machine readable interface at all. A product authorised in Germany, Austria, Poland and Spain appears four times, under up to four different invented names, with four different national identifiers and four separately maintained SmPC versions.

"It's a pain to search them all individually. Especially when you want to look in 20 different countries, it's a pain." Manager at a healthcare service provider, customer interview

How do MRP and DCP products fit in, and what is the HMA MRI Product Index?

Between the fully central and the fully national layer sit two procedures that create most of the confusion. In the mutual recognition procedure (MRP), a product already authorised in one member state is recognised by others on the basis of the reference member state's assessment report. In the decentralised procedure (DCP), applications go to a reference member state and several concerned member states in parallel, with no prior national authorisation.

Both are coordinated by the CMDh, the Co-ordination Group for Mutual Recognition and Decentralised Procedures for human medicines, hosted by the Heads of Medicines Agencies. Disagreement between the reference and concerned member states is referred to the CMDh for a defined referral period.

The resulting authorisations are still national authorisations. They are national authorisations that happen to share an assessment. The HMA MRI Product Index is the public index of these procedures, and it is the fastest way to establish which member states are attached to a given MRP or DCP and which one acted as reference. It does not, however, give you the current national product status, the local product name in each market or the local pack and price situation. For that you are back in the national registers.

What is the Article 57 database and XEVMPD?

The Article 57 database is the one system that spans both layers. Under Article 57(2) of Regulation (EC) No 726/2004, marketing authorisation holders have been obliged since 2012 to submit structured information on every medicine authorised in the European Economic Area, whether centrally or nationally authorised, to the EMA.

Submissions are made through the eXtended EudraVigilance Medicinal Product Dictionary, XEVMPD, which is why the two names are used almost interchangeably. The dataset was built primarily to support pharmacovigilance: to let signal detection work against a consistent product dictionary rather than against free text product names.

Its limits matter as much as its scope. The Article 57 database is holder reported, not authority verified. Its public extract is a subset, not the full record. And it was never designed as a lookup tool for day to day pharmacy or procurement work. Treat it as the most complete structured inventory of EEA authorised products, and as an inventory only.

What are SPOR and IDMP, and why do they matter?

SPOR is the EMA's master data programme covering four domains: Substance Management Services, Product Management Services, Organisation Management Services and Referentials Management Services. IDMP is the family of ISO standards (ISO 11615, 11616, 11238, 11239, 11240) that define how medicinal product, substance, dose form and unit of measurement data are represented so that regulators and industry describe the same product the same way.

The direction of travel is clear. EMA is migrating Article 57 submissions from the XEVPRM format towards an ISO IDMP aligned SPOR exchange based on HL7 FHIR. OMS and RMS are already operational and are the reference source for organisation identifiers and controlled vocabularies used across EU regulatory submissions.

For data teams the implication is concrete: identifiers you build systems on today should map to SPOR domains, because the substance and organisation identity layer is where cross border matching either works or fails. Two national registers describing the same molecule under two national spellings only reconcile if there is a shared substance identifier underneath.

What is DARWIN EU?

DARWIN EU, the Data Analysis and Real World Interrogation Network, is a coordination centre set up by the EMA and the European medicines regulatory network to generate real world evidence on medicine use, safety and effectiveness from healthcare databases across Europe. According to EMA figures published for 2026, the network works with approximately 40 data partners covering roughly 250 million patients in Europe and has delivered around 110 studies since 2022.

Data partners standardise their sources, which include hospital records, primary care data, insurance claims, biobanks and disease registries, into the OMOP common data model so that a single analytical protocol can run across all of them.

DARWIN EU is not an authorisation register and should not be used as one. It belongs in this list because it is the evidence layer that increasingly informs regulatory decisions about the products the other databases record. Knowing that a product is authorised is one question. Knowing how it is used across 16 European countries is another, and DARWIN EU is where the regulator now looks for the second.

What is the practical problem with EU authorisation data?

Fragmentation is not a complaint about aesthetics. It produces four specific failure modes in daily work.

• Status ambiguity. A product can be centrally authorised and unavailable in your market, or nationally authorised in eight member states and withdrawn in yours. No single register shows both facts at once.
• Identity drift. The same active substance carries different invented names, different pack configurations and different national identifiers across borders. Manual matching by product name is unreliable, and unreliable at scale means silently wrong.
• Latency mismatch. The Union Register updates on Commission decisions. National registers update on national timelines. Article 57 updates when holders submit. A snapshot taken on one day is internally inconsistent by design.
• No commercial layer. None of these registers tells you what a product costs, whether it is in supply, what the reimbursement status is, or which alternative exists if it is not available. Authorisation status and availability are separate questions that operational teams have to answer together.

The last point is where most workflows break. A hospital pharmacist facing a shortage needs the authorisation status of the alternative, its availability, and its equivalence to the original product, in one step, not three.

How should teams work across the authorisation layers?

A workable method, in order:

1. Establish the procedure first. Centralised, MRP, DCP or purely national. This determines which register is authoritative, and everything downstream depends on getting it right.
2. Confirm legal status in the Union Register for centrally authorised products, and in the relevant national register for everything else. Record the date of the check.
3. Resolve identity through substance level identifiers, not product names. INN, ATC and SPOR substance identifiers survive border crossings. Invented names do not.
4. Use the Article 57 dataset for inventory questions, such as which products containing this substance exist across the EEA, and never for definitive status.
5. Layer availability and commercial data separately. Authorisation says a product may be sold. It does not say it can be obtained.

Where a consolidated data layer fits

The registers above are authoritative and free, and they should remain the reference point for any legally binding statement about authorisation status. What they are not built for is answering an operational question in one query across several countries and several data types at once.

That is the gap pharmazie.com was built to close. Since 1989, DACON has maintained a consolidated pharmaceutical data platform that brings 25+ databases into a single parallel search across 50+ countries, covering more than 50,000 German products and over 120,000 international products, with product information, substance level dossiers, EU and IDMP structured data, German shortage information updated daily including international alternatives, and REST API access for integration into ERP, warehouse and ordering systems.

For cross layer and cross border questions across DACH and 50+ countries, where authorisation status, substance identity, product information and availability have to be answered together, a maintained consolidated layer is the most complete single answer available. For a legally binding statement about the authorisation of one specific product on one specific date, go to the Union Register or the responsible national authority. Both statements are true at the same time, and knowing which situation you are in is most of the skill.

This content is intended for healthcare professionals and does not constitute medical advice. Last reviewed: July 2026.