Regulatory Pathways: ANSM and the "Simplified Registration"
As of 2026, herbal products in France are strictly governed by the ANSM (National Agency for the Safety of Medicines) under the framework of EU Directive 2004/24/EC.
Traditional Use Registration (TUR): This remains the primary pathway for products with a documented history of at least 30 years (15 of which must be in the EU). In 2026, this pathway allows manufacturers to market products without new clinical trials, provided they adhere to established EU Herbal Monographs.
Well-Established Use (WEU): For substances like Valerian or St. John’s Wort, manufacturers can obtain a Marketing Authorization (AMM) by citing 10+ years of robust scientific literature, effectively treating the herb as a "natural generic."
The "Pharmacist Monopoly": France maintains a strict legal "monopoly" on the sale of medicinal plants. While 148 plants are deregulated for grocery sale, hundreds of others—especially those with potent therapeutic claims—can only be legally dispensed by a qualified pharmacist.
