Liability for damage to medicinal products is regulated in the Sixteenth Section of the AMG in §§ 84 ff. If a pharmaceutical company places a drug on the market within the scope of this law, it is obliged to compensate the injured party for the resulting damage.

The scope of the obligation to compensate in the event of death or bodily injury and the statutory maximum amounts can be found in §§ 86 - 89.
Finally, § 94 regulates the details of the coverage to be provided (product liability insurance).
These requirements must be met by all companies that place medicinal products on the market in Germany. It does not matter whether they are based within or outside the European Union.

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