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--- algae:pharma_medical [2026-09-13 21:46] – [Food supplement vs. medicinal product] robert
+++ algae:pharma_medical [2026-09-14 00:40] (current) – [Good Manufacturing Practice (GMP)] robert
@@ Line 55: / Line 55: @@
 ==== 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://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L0083-20220101|EURlex]].
+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://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L0083-20250101|EURlex]].
 __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.
+----
+=== Forthcoming changes ===
+Following years of negotiations, the final texts of the new EU Pharma Package (Directive and Regulation) were officially published in early 2026. [[https://dlrcgroup.com/updates-to-the-eu-pharmaceutical-reform-2026/|HSFKramer]]. This package will fully replace and repeal Directive 2001/83/EC and Regulation (EC) No 726/2004 once it takes full effect (expected around 2028).
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