What is a Parallel Distributor?

Provides information on the company type parallel distributor

Written by Tracy Slosse
Updated over a week ago

The Parallel Distributor does not hold a marketing authorisation in the terms of Community law. Instead, the parallel distributor/importer is a holder of either specific product authorisations issued by national competent authorities in an abbreviated procedure or the holder of an EMA distribution notice.

The national authorisations may be regarded under the respective national rules as « marketing authorisations » and the holder of such authorisations, for example in Germany, is a pharmaceutical entrepreneur comparable in legal status to any pharmaceutical manufacturer. In the case of centrally approved products, the product can by definition circulate in the entirety of the EEA market; when it is commercialized by a parallel distributor, the EMA only issues a so called « distribution notice » to this distributor.

In addition, parallel distributors must repackage the product which they handle in order to comply with the labelling and other regulatory and trademark requirements of the destination market, and repackaging is a manufacturing activity regulated by GMP. The FMD correspondingly speaks of "Manufacturing Authorisation Holders" when it means on the one hand marketing authorisation holders and on the other parallel distributors. For these reasons, parallel distributors connect to the hub, comparable to other (normal) manufacturers.

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