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edited by AIFA’s Office of Osmed and HTA

Glossary


MANUFACTURER
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. [Source: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use]
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