Herbal Medicines
This page contains information on how to place herbal medicines (herbal medicinal products) onto the Irish market. It includes general information on herbal medicines for members of the public as well as information for those who intend to manufacture, sell, or provide herbal medicines.
A herbal medicine (also called a traditional herbal medicinal product or THMP for short) may be placed onto the Irish market only after the HPRA has granted a licence for the product. The legal basis for granting the product licence is the Traditional Herbal Medicinal Products Directive (2004/24/EC) This directive became law in Ireland in July 2007, under statutory instrument S.I. No. 540 of 2007. Before a herbal medicine is granted a licence, the HPRA must ensure the product has a history of traditional use and is of acceptable safety and quality. When these conditions are satisfied, the product is approved for traditional use by the HPRA and is allocated a TR number.
Refer to Traditional Herbal Medicines for a list of the traditional herbal medicinal products that have been approved and granted a TR number by the HPRA. Clicking on the name of a product will open a page. The product information is included on this page.
Sometimes a herbal product does not satisfy the conditions necessary for the granting of a TR number. In these cases, the product may still be granted a licence by the HPRA; however, different conditions must be satisfied. When these conditions are fulfilled, the product will receive a PA number. More detailed information on how to obtain a PA number is available at New Products .
Information for Members of the Public
Members of the public can find more general information on herbal medicines at Information for the Public THMPs
Information for Retailers
Information for those wishing to sell herbal medicines (pharmacies and general retailers) is available at Information for Retailers - THMPs (hpra.ie)
Information for Industry
Information for those who manufacture herbal medicinal products and who wish to apply to the HPRA for a licence to place a herbal medicinal product onto the Irish market is available at Guide to THMP Registration Scheme
Information for Herbal Practitioners
If a herbal practitioner has a personal consultation with another individual and supplies that individual with a herbal preparation, this is not seen as the placing of a herbal medicinal product onto the Irish market. Such herbal preparations do not necessarily need to be licenced by the HPRA.
However, it should be noted that:
- Some herbal substances are controlled under the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, and therefore cannot be supplied to an individual by a herbal practitioner.
- The HPRA does not regulate the activities of herbal practitioners. Any questions about herbal practitioners must be addressed to the department of health.
Contact Details
- Email for general queries in relation to herbal medicinal products: info@hpra.ie.
- Email for queries relating to the classification of herbal substances and herbal products: classification@hpra.ie.
- Email for queries concerning importation, manufacture and/or distribution of medicinal products: compliance@hpra.ie.
- Queries concerning herbal practitioners or alternative medicine practitioners should be directed to the Department of Health.
- Queries concerning food and food supplements should be directed to the Food Safety Authority of Ireland (FSAI) at info@fsai.ie.