algae:pharma_medical
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| algae:pharma_medical [2026-09-13 21:02] – [EU Medical Devices Regulation (MDR)] robert | algae:pharma_medical [2026-09-14 00:40] (current) – [Good Manufacturing Practice (GMP)] robert | ||
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| === Food supplement vs. medicinal product === | === Food supplement vs. medicinal product === | ||
| - | Under Directive 2001/83/EC on medicinal products for human use, a substance is classified as a medicine either because of its __presentation__ (it is presented as having properties for treating or preventing disease in humans) or because of its __function__ (it is capable of restoring, correcting or modifying physiological functions by exerting a pharmacological, | + | Under Directive 2001/83/EC on medicinal products for human use [[https:// |
| 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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| ==== EU Medical Devices Regulation (MDR) ==== | ==== EU Medical Devices Regulation (MDR) ==== | ||
| - | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, | + | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices [[https:// |
| __Relevance to algae:__ The MDR is the primary EU legal framework for medical devices. It applies directly to algae-derived materials when they are: | __Relevance to algae:__ The MDR is the primary EU legal framework for medical devices. It applies directly to algae-derived materials when they are: | ||
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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.1789333333.txt.gz · Last modified: by robert