Traditional herbal medicine: the case of throat lozenges
Le 13 January 2025
Throat lozenges based on Erysimum: what regulations?
Indication and active substance
📌 Indication: cough, sore throat
📌 Active substance: Erysimum extract
Regulatory regime
Lozenges containing Erysimum are considered a traditional herbal medicinal product.
Why this medicine status?
✔️ Erysimum has a traditional use for soothing the throat, irritations, and cough.
✔️ A monograph published by the European Medicines Agency (EMA) confirms its traditional medical use.
✔️ To be marketed, the product must obtain a Marketing Authorization (MA) as a traditional herbal medicine.
Differences with a dietary supplement
Unlike dietary supplements, a traditional medicine can claim therapeutic use if it complies with a validated monograph.
Conclusion
Erysimum is a typical example of a plant used in traditional medicine. Its commercialization is governed by strict regulations and requires specific authorization as a traditional herbal medicine.
Frequently asked questions about traditional herbal medicines
Does a herbal-based medicine need to be authorized in order to be marketed?
Yes, all medicines, whether they contain plant-based substances or not, must obtain a Marketing Authorization (MA) before they can be marketed in Europe. Pharmaceutical legislation thus protects public health by ensuring the safety, efficacy, and quality of medicines, even when they contain only plants.
What is the difference between a herbal-based medicine and a traditional herbal-based medicine?
herbal-based medicines can be considered “traditional” when they contain only plants or plant preparations with a traditional use in the desired indication for at least 30 years, including at least 15 years in Europe. only medicines taken orally, applied externally, or inhaled can claim this status as a traditional herbal-based medicine.
What is the difference between a dietary supplement and a medicine?
The differences are numerous, but the main difference concerns their health objective: medicines are designed to cure or correct the symptoms of one or more diseases, whereas dietary supplements are designed to complement a normal diet and are not intended to prevent or cure a disease.