Own EEA entity
import authorisation + QP in-houseSet up an EEA company that holds the import authorisation and employs or contracts the QP. Most control, highest fixed cost — the choice when Germany/EU is a core market.
A marketing authorisation says your medicine may be sold in Germany. It does not let a single box cross the border. To bring product from outside the EU to a German customer you need an import authorisation, a qualified person to release every batch, and — often — each batch re-tested on arrival. This is where non-EU manufacturers are most often surprised.
Under the German Medicinal Products Act (AMG), manufacturing medicinal products requires a manufacturing authorisation under Section 13 (Herstellungserlaubnis), and importing them from outside the EEA requires an import authorisation under Section 72 (Einfuhrerlaubnis), plus a country-of-origin certificate under Section 72a. Both hinge on GMP compliance and on a Qualified Person (sachkundige Person) who certifies and releases every batch. For product from a third country, EU law requires each batch to undergo full re-testing in the EEA before that release — unless a Mutual Recognition Agreement removes it. No marketing authorisation substitutes for any of this.
Companies treat “we are approved in Germany” as the finish line. Approval is the right to be on the market. This is the right to put product there.
The marketing authorisation is about the product: its quality, safety and efficacy. The manufacturing and import authorisations are about the operation: whether the site, the people and the processes that make or bring in that product meet good manufacturing practice. They are assessed by different logic, and a company can hold one without the other — which is exactly the trap.
For a manufacturer based outside the EEA — in the US, Japan, Korea, India, China — the practical consequence is blunt: you cannot simply ship approved product to a German buyer. Someone established in the EEA must hold the import authorisation and take responsibility for release.
Authorised to sell, and licensed to supply, are two different permissions. You need both, and they are granted by different tests.
For product manufactured outside the EEA, this is the chain. Every link is a legal requirement, and the Qualified Person's signature sits at the centre of it.
Both live in the AMG; which applies depends on whether you make in Germany or bring product in from outside the EEA. Many companies end up needing to understand both.
| Manufacturing authorisation | Import authorisation | |
|---|---|---|
| Legal basis | Section 13 AMG (Herstellungserlaubnis) | Section 72 AMG (Einfuhrerlaubnis), plus Section 72a certificate |
| Triggered by | Manufacturing, or testing, medicinal products. | Importing medicinal products (and certain active substances) from a third country. |
| Core test | GMP: suitable premises & equipment, suitable responsible persons, state-of-the-art methods. | GMP-equivalent control of the imported product, evidenced quality from the origin. |
| Needs a Qualified Person | Yes. | Yes — and the QP carries the batch-release duty on import. |
| Validity | Granted without a time limit; valid until revoked. | |
The authorisation is site- and scope-specific, and issued after inspection by the competent authority of the relevant German federal state. It is not a one-form exercise: the assessment focuses on rooms, equipment, the responsible persons and whether methods match the current state of the art.
Every importer of medicinal products from a third country must have at least one Qualified Person at its disposal. Nothing is released without them.
The QP — in German the sachkundige Person, in EU law the person of Article 51 of Directive 2001/83/EC — personally certifies, in a register, that each batch has been manufactured and checked in compliance with EU GMP and with the marketing authorisation, before it can be released for sale. It is a named individual with defined qualifications and personal responsibility, not a job title you can spread across a team.
The QP does not work for your headquarters in Boston or Seoul — they act within an EEA-established authorisation holder and answer to the German authority. Their signature is the last gate before your product can be supplied. If you do not have your own EEA entity with a QP, you are relying on a partner's, which means your ability to supply Germany depends on a relationship you do not fully control.
This is the same structural theme that runs through every stage of a regulated entry — the trial's legal representative, the device's authorised representative, the medicine's authorisation holder, and now the import QP. Different names, one question: who holds your access.
The requirement that surprises non-EU manufacturers most: product already tested at origin is, as a rule, tested again in the EEA.
For medicinal products coming from a third country, EU law requires each production batch to undergo, in a member state, a full qualitative analysis, a quantitative analysis of at least the active substances, and the other checks needed to ensure quality against the marketing authorisation. In practice this means a GMP-compliant quality-control laboratory in the EEA re-tests each incoming batch before QP release.
The one thing that removes this is a Mutual Recognition Agreement (MRA) between the EU and the country of origin covering GMP. Where an MRA is in force for the relevant product category, the EEA re-testing can be waived. Whether one applies to your site and product is a question worth answering early — it changes both cost and lead time materially.
Tested at home is not tested for Germany. Plan for a second test unless an MRA says otherwise.
There is no version of this where a company outside the EEA supplies Germany without an EEA operational footprint. The realistic options:
Set up an EEA company that holds the import authorisation and employs or contracts the QP. Most control, highest fixed cost — the choice when Germany/EU is a core market.
Use a contract organisation that holds the import authorisation and provides QP batch release and, where needed, the EEA re-testing lab. Faster and lighter — but a dependency to manage.
Either way, this is an operational layer that must exist before the first shipment, alongside the marketing authorisation, not after it. It also connects directly to how product then reaches the market — see pharma distribution for the GDP and channel side, and pharmacovigilance & GxP for the standing officer roles.
We help non-EU manufacturers put the operational layer in place — the import-authorisation route, own entity vs partner, QP batch release, the re-testing question and whether an MRA helps — so an approved product can actually reach a German customer.