algae:pharma_medical
Differences
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| Both sides previous revisionPrevious revisionNext revision | Previous revision | ||
| algae:pharma_medical [2026-09-13 21:44] – [Food supplement vs. medicinal product] robert | algae:pharma_medical [2026-09-14 00:40] (current) – [Good Manufacturing Practice (GMP)] robert | ||
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| This means that: | This means that: | ||
| - | * An algal extract sold as a food supplement with claims limited to normal physiological function (e.g. " | + | * An algal extract sold as a food supplement with claims limited to normal physiological function (e.g. " |
| * The same extract, marketed with claims about treating, curing or preventing a specific disease, or with a pharmacological dose and a demonstration of pharmacological activity, is a medicinal product by presentation or by function, even if the extract itself is identical. | * The same extract, marketed with claims about treating, curing or preventing a specific disease, or with a pharmacological dose and a demonstration of pharmacological activity, is a medicinal product by presentation or by function, even if the extract itself is identical. | ||
| * A product that straddles this line will be classified as a medicinal product under Article 2(2) of Directive 2001/83/EC, which provides that in case of doubt, medicinal products law prevails. | * A product that straddles this line will be classified as a medicinal product under Article 2(2) of Directive 2001/83/EC, which provides that in case of doubt, medicinal products law prevails. | ||
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| ==== Human Medicines Directive ==== | ==== Human Medicines Directive ==== | ||
| - | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [[https:// | + | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [[https:// |
| __Relevance to algae:__ This Directive is the principal EU legal framework for medicines. It is relevant to algae in the following contexts: | __Relevance to algae:__ This Directive is the principal EU legal framework for medicines. It is relevant to algae in the following contexts: | ||
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| The European Pharmacopoeia establishes quality standards (identity, purity, assay) for pharmaceutical-grade algal materials. Compliance with Ph. Eur. monographs is expected by regulatory authorities and buyers in the pharmaceutical supply chain. | The European Pharmacopoeia establishes quality standards (identity, purity, assay) for pharmaceutical-grade algal materials. Compliance with Ph. Eur. monographs is expected by regulatory authorities and buyers in the pharmaceutical supply chain. | ||
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| + | ---- | ||
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| + | === Forthcoming changes === | ||
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| + | Following years of negotiations, | ||
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algae/pharma_medical.1789335896.txt.gz · Last modified: by robert