Article 1

For the purposes of this Directive, the following shall have the meanings hereby assigned to them; 1. Proprietary medicinal product: Any ready-prepared medicinal product placed on the market under a special name and in a special pack. 2. Medicinal product: Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product. Any matter irrespective of origin which may be: - human, e.g. human blood and human blood products; animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, etc; vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts, etc; chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.