Directive 2001/83/EC of the European Parliament and of the… Article 3

Article 3

This Directive shall not apply to: 1. Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula). 2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the official formula). 3. Medicinal products intended for research and development trials. 4. Intermediate products intended for further processing by an authorized manufacturer. 5. Any radionuclides in the form of sealed sources. 6. Whole blood, plasma or blood cells of human origin.

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Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 3 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

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