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Parallel import of medicinal products

What is a parallel imported medicinal product?

Pharmaceutical companies/manufacturers market many of their medicinal products in Germany as well as in other Member States of the European Union (EU) or the European Economic Area (EEA). For each of these products they hold a separate national marketing authorisation in the respective Member State. A ’parallel imported medicinal product’ is bought by a third company independent of the original marketing authorisation holder (MAH) or manufacturer in another Member State of the EU or EEA and is imported into Germany to be marketed here in parallel to the product marketed by the original pharmaceutical company.

In economic terms, parallel import of pharmaceuticals is a consequence of the differing price levels for pharmaceuticals within the EU or EEA.

No parallel imported medicinal product may be imported or placed on the German market unless the company has received a corresponding licence by the national competent authority for human medicinal products – i.e., either the BfArM (Federal Institute for Drugs and Medical Devices) or the PEI (Paul-Ehrlich-Institut). Parallel import is not possible if the medicinal product is authorised and marketed outside the EU or EEA.

Further Information on the parallel import of medicinal products is available on our German website.