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Healthcare & Life Sciences - Germany

Standard distribution agreements for pharmaceutical products

Author

Contributed by SKW Schwarz Rechtsanwälte

Tatjana Schroeder

July 22 2015
Background
Sample agreement
Background
Manufacturers of pharmaceutical products not only sell products themselves, but also use external
partners to get their products to market and to patients. In order to standardise these relationships, a
manufacturer should establish standard agreement structures with its distribution partners.
In order to prepare a standard agreement, the manufacturer must consider the relevant local laws
and regulations, which may determine, among other things:
l

what constitutes the last manufacturing step;

l

who holds the marketing authority; and

l

who deals with issues such as pharmacovigilance in relation to local authorities.

Within the European Union, such regulations are generally standardised, while in other countries only
local parties can hold the marketing authority.