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TL;DRThe marketing authorisation holder, in German the Zulassungsinhaber and in the sense of the Arzneimittelgesetz the pharmazeutische Unternehmer, is the legal entity that holds a medicine's marketing authorisation and carries the legal responsibility for it: quality, product information, pharmacovigilance and placing on the market. It need not be the manufacturer.
The holder answers one question: who is legally accountable for this medicine on the market. That is a different question from who physically makes it and who ships it. Those are three roles that often sit in three different companies, and treating them as one is the most common mistake in this area. The MAH is the name on the authorisation, not necessarily the name on the factory.
Four roles sit close together and are easy to confuse. The marketing authorisation holder is the EU regulatory concept, the German Zulassungsinhaber is its translation, and the pharmazeutische Unternehmer is the term the German Arzneimittelgesetz uses. For an authorisation-required medicine the pharmazeutische Unternehmer is, per Paragraph 4 Absatz 18 AMG, the holder of the authorisation, so for a normal product the two coincide. The term is broader, though: anyone who places a medicine on the market under their own name, for example in parallel distribution, is also a pharmazeutische Unternehmer.
| Role | German term | What it is | Reference |
|---|---|---|---|
| Marketing authorisation holder | Zulassungsinhaber | The legal entity that holds the authorisation and bears legal responsibility for the product across its lifecycle | EMA |
| Pharmazeutischer Unternehmer | pharmazeutischer Unternehmer | For authorisation-required medicines, the holder of the authorisation; also anyone placing a product on the market under their own name, e.g. in parallel distribution | Paragraph 4 Absatz 18 AMG |
| Manufacturer | Hersteller | The site that physically produces or batch-releases the medicine under a manufacturing authorisation; need not be the MAH | manufacturing authorisation |
| Local representative | Örtlicher Vertreter | An entity the MAH may appoint to represent it in a member state; a contact point, not the holder | EMA |
One practical marker follows from German law: the name or company and address of the pharmazeutische Unternehmer must appear on every medicine placed on the market, under Paragraph 9 Absatz 1 AMG. So the company printed on a German pack is the pharmazeutische Unternehmer, which for a standard product is the Zulassungsinhaber, but for a parallel import can be the parallel distributor rather than the original holder.
Once the authorisation is granted, the holder is accountable for the product throughout its life on the market. The core obligations are these.
Pharmacovigilance carries a named obligation. A marketing authorisation holder must have a qualified person responsible for pharmacovigilance, the QPPV, who resides and operates in the European Union and is in place at all times, in line with Article 104(3)(a) of Directive 2001/83/EC. The holder retains full responsibility for pharmacovigilance tasks even where they are subcontracted to a third party.
The holder is named in the product information and in the authorisation itself. In the SmPC (Fachinformation) it sits in section 7, headed Marketing authorisation holder, directly above section 8, which carries the marketing authorisation number. For centrally authorised products the holder is also published in the EU product data alongside the number and the country of authorisation. On the pack itself, German law shows the pharmazeutische Unternehmer under Paragraph 9 AMG, which is the holder for a standard product.
The holder can change without the product changing. A transfer of marketing authorisation is the procedure by which an authorisation moves from the current holder to a new holder that is a different legal entity. It can only be initiated once the authorisation has been granted, and for a centrally authorised product the transfer is authorised from the date on which the European Commission notifies its decision. The transferred medicine itself, its composition, its SmPC and its pack, stays the same; only the holder and the associated responsibilities move across. A mere change of name or address of the same legal entity is not a transfer but a variation.
For an aggregator this matters because a transfer changes who is legally accountable while the article on the shelf, and its PZN, may be unchanged. The holder recorded against a product is therefore a value that can move under a stable trade identifier.
On pharmazie.com the holder and the related contacts are fields on the article rather than something you search for on their own:
One honest limitation: a database copy of the holder is a reflection of the register, not the register itself. Right after a transfer, an authority decision can precede the update of any downstream data source, so where a decision turns on who legally holds the authorisation today, the authoritative source is the competent authority (in Germany the BfArM or the Paul-Ehrlich-Institut) or the EU Union Register, not a data copy.
