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preamble_1813

2.2.62.1.5. Biological products are those products derived from living organisms, that are manufactured and distributed in accordance with the requirements of national governmental authorities which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines and diagnostic products.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-31 · Text as adopted (Official Journal); later amendments are not incorporated in this text.