Natural or legal person with responsibility for the manufacturing of a product.
Manufacturing includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabeling, quality control, release, storage, and distribution of active pharmaceutical ingredients (APIs) and related controls.

In German: Hersteller
Pharmazeutisches Unternehmen, das Arzneimittel produziert (im Gegensatz zu Depositeur).

Last update: 21 June 2023

Source: EU, updated by PPRI