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ORIGINAL.
AFFORDABLE.
SAFE.

IMPORT 

Import of medicinal products and medical devices

Parallel imports and re-imports of EU medicinal products, narcotics and EU medical devices play an essential role in closing supply gaps in our healthcare system. Imported medicinal products are always original preparations. They are therefore subject to strict monitoring by the state regulatory and supervisory authorities. On average, medicinal products cost significantly more in Germany than in many other EU countries. This can lead to price advantages that relieve our healthcare system and possibly also reduce the patient's private expenses.

 

In 2017 alone, imported medicinal products enabled direct savings of €264 million* in Germany, and the trend is rising: in 2020, the savings amounted to around €300 million, in 2021 to €340 million and in 2022 to over €400 million.

 

For patent-protected medicinal products, parallel imports and re-imports are the only way to obtain the respective preparation under more favourable conditions. This is the only way to create competition that leads to manufacturers concluding rebate contracts with health insurance funds. Hence, the solidarity community – i.e. health insurance funds and patients alike – indirectly saved around €2.6 billion in 2019. ** According to more recent calculations, the indirect savings amounted to around €4.5 billion in 2020. ***

* Source: PROGNOS study "Financial impacts of the import of medicinal products on the healthcare system" from November 2018 and update based on market data from 2022.

 

** Source: inno AG study "Secondary analysis of indirect savings effects and potential of parallel imports of medicinal products", April 2019

 

*** Source: Prof. Peter Heydebreck, "Expert opinion on indirect savings effects and potential through the parallel import of medicinal products", June 2021

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IDENTICAL. COMPLIANT. VERIFIED.

EU medical devices

EU medicinal products come from other EU countries. However, they are subject to all regulations of the German Medicinal Products Act. They are original preparations from the respective manufacturer and therefore absolutely identical in terms of effect and application. The distribution of EU medicinal products from parallel import requires approval by the Federal Institute for Drugs and Medical Devices (BfArM). For centrally approved medicinal products, this is referred to as parallel distribution. Here, the company needs evidence of a completed notification procedure at the European approval authority (EMA). These approval and notification procedures demonstrate and ensure the conformity of the medicinal product with all legal requirements. To prevent counterfeits, all medicinal products we distribute are included in the European Medicines Verification System (EMVS) with an individual serial number. This allows us to directly verify upon receiving the delivered goods that they are original manufacturer's products. Through this serialisation and verification process, we comply with the Falsified Medicines Directive (FMD).

EU medicinal products

Import medical devices are original products from the manufacturer approved in another EU Member State according to uniform legal requirements and quality standards, possibly only in different country-specific packaging.

 

As a legally controlled pharmaceutical wholesaler, we import them to Germany. We are registered as a parallel importer with the national authorities. In Germany, the products are labelled and repackaged in accordance with all legal regulations. They receive our own pharmaceutical central number (PZN) and German-language labels.

 

The safety of EU medical devices is thus guaranteed at all times.

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PRODUCTION.
IMPORT. TRADE.

Parallel imports and re-imports are not the same thing. In parallel import, the manufacturer produces the products at a foreign production site. The parallel importer buys the products in other European countries and imports them to Germany. In re-import, the production takes place at a German site. From there, the products are exported to other European countries and re-imported to Germany by the importer.

Re-import and parallel import

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SUPPLY.
INFORM. SAVE.

Originals at an attractive price

Why import goods from other EU countries that could also be procured domestically? The reasons include improving the supply situation and price advantages. Within the single European economic area, there are significant price differences for many products – including medicinal products and medical devices. These price differences arise due to the different national health and taxation systems. In particular, patent-protected medicines are significantly cheaper in many other EU countries than in Germany. The legislator is interested in ensuring optimal healthcare provision at the lowest possible cost to the taxpayer. In Germany, pharmacists must inform their patients about equivalent, cheaper alternatives: This is even legally regulated in Section 129 of the Social Code Book V. Medicinal products and medical devices from parallel imports play a major role in this.

It also supports the principle of free movement of goods in Europe.

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    Patient reminder card
  • Why do import medicinal products look different from the original?
    This is because the packaging from abroad does not contain German texts. However, labelling in German is required by law. For this reason, as a parallel importer we produce packaging in German including German instructions for use, in accordance with German labelling obligations, to ensure correct medicinal product information for the patient. Visually, the packaging may differ slightly from the original packaging.
  • What are the advantages of medicinal products and medical devices from parallel import?
    You get original products at lower prices. Due to different health systems and taxation, the products can often be purchased abroad under better conditions. This relieves the health system as a whole. Trading partners, pharmacies and patients can all benefit from the price advantages. Procurement abroad can also close supply gaps in the domestic market.
  • How safe is a medical device from parallel import?
    As original products with the legally required CE marking, EU medical devices are subject to the manufacturer's strict quality controls and those of B2B Medical. In terms of their application and therapeutic effect, they are 100% identical to the original product. The quality of medical devices from parallel import is guaranteed at all times.
  • What are parallel imports?
    These are medicinal products or medical devices produced by an original manufacturer in another EU country. Often, the manufacturer no longer produces the product in Germany. Both the manufacturer and the importer introduce the product into Germany to sell it there, thus operating in parallel. Parallel imported products are always original products from the respective original manufacturer and have an identical therapeutic effect.
  • What are import medicinal products?
    Import medicinal products come from other EU countries. In terms of active ingredients, dosage form and type of application, they 100% match the original product as sold by the original manufacturer with its pharmaceutical central number in Germany. Moreover, they meet all the requirements of the German Medicinal Products Act.
  • What is the difference between parallel import and re-import?
    In parallel import, the manufacturer produces the products at a foreign production site. The parallel importer buys the products in other European countries and imports them to Germany. In re-import, the production takes place at a German site. From there, the products are exported to other European countries and re-imported to Germany by the importer.
  • What is the difference between import medicinal products and originals?
    Import medicinal products are always original products from the respective manufacturer. All pharmaceutically active ingredients are identical. Parallel imported medicinal products may be different purely in visual terms. As a parallel importer, we produce packaging in German adapted to German labelling obligations, to ensure correct medicinal product information for the patient.
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