Finding EU Active-Ingredient Registrations and Mapping the PZN

For an importer, reimporter or business developer, the question is rarely “is this drug approved somewhere in Europe” but “in which countries is this active ingredient registered, and which foreign product matches my German PZN”. Official EU registers answer neither well: they are split by authorisation procedure and by country, and they do not carry the PZN. This guide shows how to combine registration status per country with PZN mapping so you can identify an equivalent product for parallel or single import. It is written for professionals in pharmaceutical trade, not patients.

Where is a drug registered in Europe, and how do you check per country?

A medicinal product can be authorised through the centralised procedure, valid across the EU, or nationally in a single member state, or through mutual-recognition and decentralised procedures across several. To check where a specific active ingredient is registered you therefore have to look in more than one place: the EU-level register for centrally authorised products, and the relevant national register for the rest. There is no single official view that lists an active ingredient country by country.

Centralised vs. national authorisation: why the Union Register is not enough

The EU Union Register lists centrally authorised products only. Everything authorised nationally or by mutual recognition sits in the member states’ own registers; the EMA maintains a page of national registers but does not aggregate their content. For a sourcing decision that means the majority of products, the nationally authorised ones, are spread across 27+ separate registers with no common search.

Which database lists an active ingredient country by country?

This is the gap a commercial or integrated source fills. Instead of querying each national register, an integrated platform holds product data across 50+ countries and 120,000+ international trade products, so a single search by active ingredient returns where an equivalent is marketed, with its national identifiers. pharmazie.com is built for exactly this cross-border view, and our page on German drug databases compared places it against the official registers.

How do you map a German PZN to an EU marketing authorisation?

The PZN is a national German identifier; it does not appear in EU or national marketing-authorisation registers. Mapping therefore runs through the product’s attributes: active ingredient, strength, pharmaceutical form and package size, matched against the foreign equivalent. Doing this by hand across registers is slow and error-prone, which is why importers use a database that already links the German PZN to international products rather than reconstructing the match each time.

And the other way round: from a foreign product code back to a German PZN

The mapping described above runs from a German product outwards. The harder direction is the reverse one, and it is the one import and export teams face every month: you hold a national code from another market, an EAN, or nothing but a pack photo, and you need the German equivalent. There is no lookup table for this. National coding systems are not cross-referenced, and the PZN does not appear in any European register.

What works instead is attribute matching in a fixed order. Each step narrows the candidate set, and each step can fail for a reason worth recording.

Two consequences follow for anyone running this at volume. First, the result is a candidate set, not a single hit, and the last decision stays with a person. Second, the failure reason matters as much as the match: a batch run that reports only matched and unmatched throws away the information needed to fix the unmatched rows next month.

The practical test for a data source is therefore not whether it can map, but whether it exposes the attributes to match on, for both markets, in a form you can process in bulk.

Official register vs. commercial database vs. integrated platform

The three source types answer different parts of the question.

How do you find niche products for parallel trade and import?

Niche sourcing starts from a shortage or an opportunity: a product unavailable or expensive in one market that is marketed and affordable in another. The workflow is to identify the active ingredient, find the countries where an equivalent is registered, and check its trade status there. For products already being distributed centrally, the EMA register of parallel-distribution notices shows what is in play; for national sourcing, the cross-country product view is what surfaces the candidates.

What is the single-import route under sec. 73 (3) AMG?

Germany’s single-import route under sec. 73 (3) AMG allows a pharmacy to import a foreign medicinal product in individual quantities when no comparable product is available in Germany. The core conditions are that the product is lawfully marketable in the country of origin, that it is imported on a prescription and in small quantities, and that the import is documented. Finding the eligible foreign equivalent is the data problem this article addresses; the German framework for parallel import is described by the BfArM, and cross-border availability by the Heads of Medicines Agencies.

Conclusion

Checking where an active ingredient is registered and mapping a German PZN to the foreign equivalent are two halves of the same sourcing decision, and the official registers deliberately keep them apart. Combining them, registration status across 50+ countries plus PZN-to-international mapping in both directions in one workflow, is what turns a §73 or parallel-trade question into a fast answer. pharmazie.com is the consolidated pharmaceutical data platform by DACON Datenbank Consulting GmbH that bundles 25+ specialist databases into a single search, exclusively for healthcare professionals, with product data across 50+ countries. The clearest way to see the sourcing workflow is a short demo.

Further reading: German drug databases compared

See the cross-border sourcing workflow: book a demo