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TL;DRThe EU marketing authorisation number, in German the Zulassungsnummer, is the regulatory licence identifier that a medicine receives when a competent authority grants its marketing authorisation. It identifies the authorisation, not the pack in trade, and it is the number printed in section 8 of the Summary of Product Characteristics.
The number answers one question: under which licence is this medicine allowed on the market, and who granted it. That is a different question from the one a wholesaler or a pharmacy asks, which is how to order and bill a specific pack. The two questions have two different numbers, and confusing them is the most common mistake in this area.
A medicine authorised through the centralised procedure carries a number in the form EU/1/YY/NNN/NNN. The scientific assessment is run by the European Medicines Agency, but the authorisation itself is granted by the European Commission, and the number is issued with that decision. One authorisation covers every pack size of the product, which is why the number ends in a separate presentation segment.
Taking one of the authorisation numbers for Humira, EU/1/03/256/007, the segments read as follows.
| Segment | Example | Meaning |
|---|---|---|
| Prefix | EU | Authorised centrally, valid union-wide |
| Type digit | 1 | 1 for a human medicine, 2 for a veterinary medicine |
| Year | 03 | Year of first authorisation, here 2003 |
| Product number | 256 | Running number of the medicinal product |
| Presentation number | 007 | The specific pack size or presentation |
Because the authorisation is central, the same number is valid in every EU member state and in the EEA states Iceland, Liechtenstein and Norway. That union-wide validity is the point of the EU/1 prefix: one licence, one number, one text, everywhere.
Not every medicine is authorised centrally. A product authorised through a national, a mutual recognition or a decentralised procedure carries a national authorisation number issued by the national competent authority. In Germany that authority is the BfArM for most medicines, and the Paul-Ehrlich-Institut for vaccines, sera, blood products and advanced therapy medicinal products.
| EU central authorisation | National authorisation (Germany) | |
|---|---|---|
| Format | EU/1/YY/NNN/NNN, for example EU/1/03/256/007 | A multi-digit number, for example 12345.00.00, with suffixes for strength and pack |
| Granted by | The European Commission, after EMA assessment | The BfArM, or the Paul-Ehrlich-Institut for vaccines, sera, blood products and advanced therapies |
| Validity | All EU member states plus the EEA states Iceland, Liechtenstein and Norway | Germany only |
| Recognisable by | The EU/ prefix | A national numbering scheme, no EU/ prefix |
The practical consequence: an EU/1 number tells you at a glance that the medicine is centrally authorised and identically valid across the union, while a national number is valid only in the country whose authority issued it.
No, and this is the distinction worth being strict about. The authorisation number is a regulatory licence identifier. The PZN (Pharmazentralnummer) is a national trade identifier, an eight-digit key assigned by the IFA GmbH for ordering, dispensing and billing in Germany.
They differ in what they count. One marketing authorisation covers several pack sizes, and each pack size carries its own PZN, so a single authorisation number sits above many PZN. The authorisation number changes when the licence is transferred or re-granted. The PZN changes when the pack changes. Neither is a substitute for the other, and neither resolves to the other without a data source that holds both keys side by side.
Two places carry it. In the product information it sits in section 8 of the SmPC, headed Marketing authorisation number(s), directly below section 7 for the marketing authorisation holder. For centrally authorised products it is also published in the EU product data, alongside the holder and the country of authorisation.
In practice two things about the number cause friction. First, it contains slashes, and national formats contain dots, and those special characters break naive search boxes and exact-match joins, so a query for the plain digits often misses the record. Second, authorisation transfers and manufacturer changes alter the number over a product's life, which means a number captured once is not a stable key you can rely on years later.
On pharmazie.com the authorisation number is a field on the article, reached from the PZN rather than searched for on its own:
One honest limitation: the authorisation number is not a stable join key. Because it can change with a transfer and because its formatting is inconsistent across procedures, an aggregator keys the record on the PZN, not on the authorisation number. Where a decision turns on the current legal authorisation status, the authoritative source is the competent authority or the EU Union Register, not a database copy.
