.png)
SummaryGermany allows medicines to be imported through three distinct legal pathways: parallel import and re-import of products already authorised in the EU or EEA, single-patient import under section 73(3) of the German Medicines Act (Arzneimittelgesetz, AMG), and temporary supply of unauthorised products during a supply shortage formally declared under section 79(5) AMG. Each pathway has a different authorising body, a different documentation burden, and a different set of people who are legally permitted to use it.
Confusing the three is the most common compliance error in pharmaceutical procurement. A hospital pharmacy that treats a single-patient import as if it were a parallel import will fail an inspection. A wholesaler that treats a declared supply shortage as a standing permission will trade outside its authorisation. This article sets out who may do what under each pathway, what documentation is required, and how the sourcing workflow actually runs in practice.
The three pathways differ in what is being imported, who authorises it, and how many patients it may serve. The table below is the fastest way to see the distinction.
| Pathway | Legal basis | What may be imported | Who may do it | Authorising body | Scale |
|---|---|---|---|---|---|
| Parallel import and re-import | Section 73(1) AMG, EU free movement of goods | Products already authorised in Germany and in the source state | Licensed importers, wholesalers with a section 52a AMG authorisation | BfArM or Paul-Ehrlich-Institut (national products); EMA notification (centrally authorised products) | Commercial, unlimited volume |
| Single-patient import (Einzelimport) | Section 73(3) AMG | Finished medicinal products not authorised in Germany | Pharmacies, hospital pharmacies, hospital-supplying pharmacies | No prior approval; conditions must be met and documented | Small quantities against a specific order |
| Supply during a declared shortage | Section 79(5) AMG | Products not authorised or registered in Germany | Marketing authorisation holders and supply chain actors, case by case | Federal Ministry of Health declares the shortage; competent authorities permit the individual measure | Time-limited, shortage-specific |
A parallel import means a company buys a medicinal product legally placed on the market in another EU or EEA member state and brings it to Germany, where it is sold alongside the original marketing authorisation holder's product. A re-import is the same mechanism applied to a product that was manufactured in Germany, exported, and then brought back. Both rest on the exhaustion of intellectual property rights and the free movement of goods within the single market, and both are lawful trade rather than an exception to the rules.
The commercial logic is price differentials. Because national pricing, reimbursement, and rebate systems set different ex-factory prices for the same product across member states, the same pack can be materially cheaper in one market than in another. Germany is the largest parallel trade market in Europe.
What parallel import is not is a shortcut around authorisation. The importer needs its own authorisation for the German market, and the repackaging and relabelling steps that make a foreign pack saleable in Germany require a manufacturing authorisation.
The authorising route depends on how the original product was authorised, not on where the importer sits.
In both cases the importer must also hold the trading authorisations described further below. Authorisation of the product and authorisation of the activity are separate questions, and inspectors check both.
Yes. The import promotion clause (Importfoerderklausel) remains in force in section 129(1) sentence 1 no. 2 of the German Social Code Book V (SGB V). Pharmacies dispensing to statutory health insurance patients are still obliged to dispense a lower-priced imported product where a defined price gap to the reference product exists. This is worth stating plainly, because the clause has been repeatedly proposed for abolition and is often reported as gone.
What did change is the structure of the obligation. The flat percentage test was replaced by a tiered price differential, and the operational target moved from a unit quota into the framework agreement between the GKV-Spitzenverband and the Deutscher Apothekerverband concluded under section 129(2) SGB V.
| Price of the reference product | Required price advantage of the import |
|---|---|
| Up to and including 100 EUR | At least 15 percent lower |
| Over 100 EUR up to and including 300 EUR | At least 15 EUR lower |
| Over 300 EUR | At least 5 percent lower |
Source: section 129(1) sentence 1 no. 2 SGB V, current consolidated text, 2026. Prices are compared after the manufacturer discounts under section 130a SGB V.
Three qualifications matter in daily practice. First, where a rebate contract under section 130a(8) SGB V applies to the prescribed product, dispensing the rebated product takes precedence over the import obligation. Second, the obligation does not apply to biotechnologically manufactured medicinal products or to antineoplastic medicinal products for parenteral use, an exemption driven by storage and transport requirements. Third, the framework agreement under section 129(2) SGB V converts the old unit quota into a savings target on the import-relevant market, currently 2 percent of theoretical turnover in that segment. A pharmacy that misses the target absorbs the shortfall itself.
Section 73(3) AMG permits a finished medicinal product that holds no German authorisation, registration, or exemption to be brought into Germany when three conditions are met cumulatively. The wording is narrow and inspectors read it literally.
Condition three is the one that generates most of the work, and it is the one that fails audits. "Not available" covers both the case where no such product is authorised in Germany and the case where an authorised product cannot be obtained. Either way the pharmacy must be able to show what it checked and when.
Section 73(3) AMG also carries two extensions. A hospital pharmacy or a hospital-supplying pharmacy may hold a reasonable temporary stock of such products for administration to hospital patients under the direct personal responsibility of a physician. And products that must be kept available for emergencies under pharmacy law, employers' liability insurance rules, or in the remit of the Federal Ministry of Defence may be stocked or procured at short notice where nothing is available in Germany for that indication.
On prescriptions, the statute is precise: ordering and dispensing require a medical or dental prescription for products not sourced from an EU or EEA member state. The detail is governed by the German Pharmacy Operating Ordinance (Apothekenbetriebsordnung). The full statutory text is available from gesetze-im-internet.de.
Section 79(5) AMG is the emergency valve. Where there is a supply shortage in medicines needed to prevent or treat life-threatening diseases, or a threatening communicable disease requiring immediate and unusually large provision of specific medicines, the competent authorities may permit, case by case, that medicinal products not authorised or registered in Germany are placed on the market on a time-limited basis and brought into Germany by way of derogation from section 73(1) AMG.
Two safeguards frame this. The product must either be lawfully marketable in the state it comes from, or the competent federal higher authority must have established that its quality is assured and that its use offers a positive benefit-risk balance according to medical science. And the trigger is formal: the Federal Ministry of Health declares that a supply shortage exists, or has ceased to exist, by an announcement published in the Federal Gazette (Bundesanzeiger), drawing on BfArM findings.
Within a declared shortage the authorities may also permit time-limited derogations from licensing requirements and other prohibitions under the AMG. In practice this is how foreign-language packs, non-German labelling, and alternative pack sizes reach the German market during a shortage. BfArM publishes the individual measures and the products concerned in its shortage measures pages. A declaration is product-specific and time-limited. It is never a standing permission.
Anyone who conducts wholesale trade in medicinal products in Germany needs an authorisation under section 52a AMG. The only exemption in the statute covers the finished medicinal products named in section 51(1) no. 2 AMG that are released for distribution outside pharmacies.
The application must name the specific business premises and the activities and products covered, and it must be accompanied by:
The authority of the federal state where the premises are located decides, and must do so within three months, with the clock suspended while it waits for additional information. Note that section 73(4) AMG expressly keeps section 52a applicable even to products brought in under the section 73(3) route, so the authorisation question does not disappear because the import is small.
The German rules sit inside an EU framework. Directive 2001/83/EC establishes the Community code relating to medicinal products for human use, including the wholesale distribution authorisation requirement that section 52a AMG transposes. The operational detail lives in the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
For an importer, the GDP chapters that bite hardest are quality management and the qualification of suppliers and customers. You must verify that the party you buy from holds a valid wholesale distribution authorisation or manufacturing authorisation in its own member state, and that the party you sell to is entitled to receive the product. Temperature control, transport qualification, and a documented falsified medicines risk assessment complete the picture. Cross-border sourcing multiplies these checks, because each counterparty sits under a different national register.
Documentation is where the three pathways diverge most sharply, and where audits concentrate.
Reduced to its working sequence, a compliant sourcing decision runs through five questions.
"What matters to us in procurement is being able to look for alternatives when a product is flagged as being in short supply." Pharmacist at a hospital pharmacy, translated from German.
Steps one and two are data problems, not legal problems. The legal test in section 73(3) no. 3 AMG asks whether an identical and comparable product is available in Germany, and the practical follow-up asks where else in Europe the same active substance and strength is authorised and obtainable. Answering that by opening one national register after another is slow, and it produces an audit trail that is hard to reconstruct.
This is the specific job pharmazie.com was built for. The platform consolidates 25+ pharmaceutical databases into one search across 50+ countries, covering more than 50,000 German products and more than 120,000 international products, with daily updated German shortage data including EU and international alternatives. For a procurement team working the two questions above, finding an equivalent authorised product in another market is exactly what that cross-border coverage is for, and it is the most complete single answer available for cross-layer and cross-border sourcing questions across DACH and 50+ countries. DACON GmbH has maintained this data since 1989.
What it does not do is make the regulatory decision for you. The pathway choice, the authorisations, and the documentation remain the responsibility of the pharmacy, the wholesaler, or the importer. What consolidated data changes is how quickly and how defensibly you get to the point where that decision can be made.
This content is intended for healthcare professionals and does not constitute medical advice. Last reviewed: July 2026.
