IMPORTED PHARMACEUTICALS
Cheaper branded medicines with the same quality
IMPORTED PHARMACEUTICALS
Cheaper branded medicines with the same quality
We import pharmaceuticals and make them fit for exclusive distribution on the German market. The branded pharmaceuticals undergo extensive quality control and are provided with either a German-language label or primary packaging of a German folding box plus German-language label. Before they are delivered to the pharmacies, we place a German-language package insert in each cardboard box.
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 public pharmacies, hospital pharmacies, and specialized pharmacies as well as full-line pharmaceutical wholesalers. Our core business is the re-import and parallel import of branded medicinal products with market authorization from EEA countries, and their distribution to pharmaceutical wholesalers and pharmacies in Germany.
Distributing roughly 1,200 pharmaceutical registration numbers (PZN), we offer a wide range of medicinal productions for different indications, including anti-rheumatic, oncology, and HIV prescription drugs.
Imported pharmaceuticals offer an effective opportunity for efficient cost savings in medical treatment. 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’).
Under German law, prescription drugs in Germany are covered by price control. However, a look across the border to our European neighbors reveals that many of these branded products are more affordable there even though they are the identical original pharmaceuticals. This is why we re-import these products. In the pharmaceutical import market, we differentiate between re-import pharmaceuticals and parallel import pharmaceuticals.
Most pharmaceuticals intended for the German market are produced by pharmaceutical companies in other EU member states. In this case, 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.’
Parallel imports, or parallel import pharmaceuticals, are thus branded products produced by pharmaceutical companies in other EU member states. We buy these products in their countries of origin, export them to Germany, and place them on the market in parallel to the corresponding German pharmaceuticals––only at a lower price.
Re-import 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 product distributed directly here in Germany.
Unlike parallel imports, in parallel distribution the imported product is a medicinal product centrally authorized in the EU or the European Economic Area. Parallel distribution does not require separate marketing authorization. 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 Amsterdam-based European Medicines Agency (EMA) or are granted national approval in Germany by BfArM on the basis of their therapeutic identity. The marketing authorization number must be provided on every package of a medicinal product.
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.
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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.
A differentiation is made between
The price difference between the preparation from the original manufacturer and the imported pharmaceutical product is due to the different healthcare systems in the various EU countries.
If patients have to cover their medicine completely by themselves or have a co-payment, the medicine imported by CC Pharma offers an inexpensive alternative.
Yes. The imported medicine is either completely identical to the German preparation from the original manufacturer in respect of its composition, or in the event of differences in excipients, these are only accepted in accordance with the case law of the European Court of Justice if they do not result in any therapeutically relevant differences.
No. A generic medicine is the “bio-equivalent” of a branded drug that can be produced by other companies following expiry of the patent term. An imported pharmaceutical is always equivalent to the original medicine prescribed. That may be a medicine protected by a patent or a generic medicine.
The information on the medicine, packaging and patient information leaflet is generally in the language of the country of origin. To ensure that it is absolutely safe for the patient to use the medicine, all relevant information is provided in German on the original packaging or on a preprinted package. Each pack also contains instructions for use in German.
Only authorized original medicinal products from the European Economic Area are allowed to be imported into Germany because the regulations for the marketing authorizations for medicinal products are harmonized in these countries.
CC Pharma as an importer and marketing authorization holder must, like a pharmaceutical company, have a graduated plan officer (Section 63a AMG), a qualified person (Section 14 AMG) and an information officer (Section 74a AMG) as well as a manufacturing authorization in accordance with Section 13 of the German Medicinal Products Act (AMG). The monitoring of regulations is the responsibility of the health authorities.
The “import quota” obliges pharmacies to sell a contractually agreed percentage of imported medicines. According to the Framework Agreement on the Supply of Medicines (Section 129 Paragraph 2 of the German Social Code SGB), the import quota is currently two percent per health fund and quarter.
Section 2 paragraph 8: Low-priced imported medicines
Imported medicines are deemed to be low-priced imported medicines within the meaning of the framework agreement that are relevant for the savings target in accordance with Section 13 of this framework agreement, if – assuming identical pack sizes (same number of units or same filling quantity) – the relevant pharmaceutical retail price of the pack for the insured person, taking into account the statutory discounts,
Yes. Pharmaceutical importers purchase the goods from a surplus inventory. In some EU countries like Poland, the portfolio of products that are allowed to be exported is adapted to the current needs of the population. This ensures that there is always a sufficient supply for a country’s own population.
