Imported Pharmaceuticals

IMPORTED PHARMACEUTICALS

CC Pharma, established in 1999, is among Germany’s leading importers of pharmaceuticals from other EU Member States. As an importer of pharmaceuticals, we specialise in the re-import and parallel import of EU pharmaceuticals into Germany, thereby providing the health market with branded products in original quality at lower prices.

CC Pharma either places the original pack into a German-language folding box or provides it with a German-language label.

We import pharmaceuticals and make them fit for distribution on the German market. The original pharmaceuticals undergo thorough quality testing and are either repacked in a German-language folding box or provided with a German-language label. Before the imported pharmaceuticals are delivered to pharmacies, we place a German-language package insert in each pack.

 

By supplying our services as a pharmaceutical importer, we actively contribute to reducing the costs of medicinal products within the scope of healthcare policy. Our customers include pharmacies, i.e. public pharmacies, hospital pharmacies and specialist pharmacies, as well as full-line pharmaceutical wholesalers.

CC Pharma distribution covers around 1,800 national standard identification codes for pharmaceuticals (Pharmazentralnummern, PZNs)

Our distribution covers up to 1,800 national standard identification codes (Pharmazentralnummern, PZNs). CC Pharma thus offers a broad range of medicinal products for various types of indications, including anti-rheumatic drugs, oncology products and anti-HIV drugs. One focus of our portfolio is on high-priced medicinal products.

In this specific field, import pharmaceuticals are one way of reducing therapy costs. However, this option is limited to pharmaceuticals for which aut-idem substitution is not excluded (the expert community also often uses the term ‘non-aut-idem list’) Further information on this topic is available at https://www.gba.de/institution/themenschwerpunkte/arzneimittel/aut‐idem/

 

IMPORTED PRESCRIPTION DRUGS

Under German law, prescription drugs in Germany are covered by price control. However, a glance across the borders in the EU soon shows that many of these branded pharmaceuticals cost less in other EU Member States than here in Germany – even though the pharmaceutical product is identical. This is why we re-import pharmaceuticals. In the pharmaceutical import market, we differentiate between re-import pharmaceuticals and parallel import pharmaceuticals.

PARALLEL IMPORT PHARMACEUTICALS

Most pharmaceuticals intended for the German market are produced by pharmaceutical companies in other EU Member States. In this case, both the pharmaceutical manufacturer and the importer import the products to Germany from another country. This type of import is therefore referred to as ’parallel import’.

The parallel import process of pharmaceuticals

Parallel imports or parallel import pharmaceuticals are thus original products produced by pharmaceutical companies in other EU Member States. We buy these products in their countries of production and then export them to Germany. CC Pharma then places these pharmaceuticals on the market in parallel to the corresponding German pharmaceuticals – albeit at a lower price.

REIMPORTED PHARMACEUTICALS

How the re-import of drugs works.

Reimported pharmaceuticals are branded pharmaceuticals that are produced in Germany and exported to another EU Member State by the pharmaceutical industry, where they will be sold at lower prices. We therefore buy these pharmaceuticals in those EU Member States and re-import them to Germany. Based on this purchasing advantage, we can offer the re-imported pharmaceuticals (branded products) at lower prices than the original products distributed directly here in Germany.

PARALLEL DISTRIBUTION VERSUS PARALLEL IMPORT

Unlike parallel imports, in parallel distribution the imported product is a medicinal product centrally authorised in the EU or the European Economic Area. Parallel distribution does not require separate marketing authorisation. However, prior to distribution, the medicinal product to be imported needs to pass the “notification procedure” at the European Medicines Agency (EMA). Once this is completed, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte. BfArM) must be notified of the intended parallel distribution in Germany.

Re-imported medicinal products are therapeutically identical to original products, and are thus absolutely safe to use. They either have been approved by the London-based European Medicines Agency (EMA) or are granted national approval in Germany by BfArM on the basis of their therapeutic identity. The marketing authorisation number must be provided on every package of a medicinal product.

CC Pharma either produces a German-language package (Europack) or re-labels the imported medicine in German, benefiting you as well as customers and patients.

The information on medicinal products is always provided in the language of the EU Member State in which the product is sold. In line with the legal regulations of the German Medicines Act (Arzneimittelgesetz, AMG), we produce a German-language package and the relevant package insert in German for the imported product, to ensure that we provide all important information on the correct use of the medicinal product in line with the legal requirements. Do you have any questions or need further advice on this topic? Contact us and we will be happy to provide assistance.

 

REGULATIONS AND LEGAL REQUIREMENTS

According to the relevant framework contract (Regulation Section 129, German Social Code, Volume V), pharmacies must sell a certain amount of imported medicines per national health insurance fund in each quarter to reach a defined ‘import quota’. They must achieve savings of 10 per cent of the import quota by the sale of lower-price imported medicines. In other words, according to the relevant regulation, each pharmacy must sell a certain percentage of imported medicines. Based on the contract for the supply of medicinal products concluded with the German Association of Health Insurance Funds (vdek contract), the ‘penalty’ (if pharmacies fail to reach the above import quota) and ‘reward’ (if pharmacies exceed the import quota) in euros are calculated per quarter and health insurance fund.