Information for Retailers - THMPs
Herbal products that contain active substances in sufficient amounts to have a medicinal effect are medicinal products. Herbal products that are presented as having properties for treating or preventing disease are also medicinal products.
The marketing of medicinal products in Ireland is regulated by the HPRA. A herbal medicinal product cannot be placed on the market unless it is the subject of either a marketing authorisation or, in the case of a traditional herbal medicinal product (THMP), a certificate of traditional-use registration granted by the HPRA. The packaging of such products will carry either a PA number (for products that are the subject of a marketing authorisation) or a TR number (for THMPs).
A list of all currently authorised medicines for which a marketing authorisation has been granted can be accessed on the HPRA’s website here:
THMPs are subject to a simplified registration procedure. They must:
- be intended and designed for use without the intervention of a medical practitioner,
- be taken orally, for external use or inhalation,
- be administered exclusively at a specified strength and dose,
- be on the market for a ‘period of traditional use’.
See list of the THMPs for which a certificate of traditional-use registration has been granted
In both of the above lists, clicking on the name of a product will open a page where its supply status (pharmacy only or general sale) is displayed.
Some herbal substances are always medicinal by virtue of their pharmacological activity. Examples include arnica, devil’s claw and frangula bark.
Other herbal substances are considered to be medicinal if a certain minimum dose is administered when the product is used as directed, but they may be acceptable in food supplements which provide smaller quantities of the herbal substance. Examples include milk thistle and saw palmetto.
Some common foodstuffs may also be included in products that are medicinal by virtue of the claims made for them: peppermint, liquorice, thyme and sage are common examples.
It should be noted that the supply of some herbal substances is controlled by the Medicinal Products (Prescription and Control of Supply) Regulations. Examples include comfrey (in oral products), Ginkgo biloba, Saint John’s wort and sassafras bark or root. However, medicinal products containing such substances may be exempted from prescription control under the terms of a marketing authorisation or a certificate of traditional-use registration granted by the HPRA.
Borderline Products Committee
If the status of a particular product is unclear, a formal opinion can be obtained by submitting the product information (composition, label, package leaflet and any proposed advertising) to the HPRA’s Borderline Products Committee, which will determine whether the product meets the definition of a medicinal product, medical device or cosmetic. Information on this procedure and an application form are available from the HPRA’s website here.
If submitting product details to the Borderline Products Committee, please ensure that the part of the plant (leaves, roots, etc.) used in the product is specified.
In cases where a herbal substance has previously been considered by the Borderline Products Committee, advice on the status of products which contain it may be available from email@example.com.
Products for oral administration containing certain herbal substances may be sold legally as food supplements provided no medicinal claims are made for them. Such products must be notified to the Food Safety Authority of Ireland (FSAI) by the manufacturer or importer. Products that have not been accepted by the FSAI cannot be sold as food supplements. The regulation of food is outside the remit of the HPRA and any queries in this area should be directed to the Food Safety Authority of Ireland (FSAI).
Herbal products for topical use (application to the skin, scalp or nails) that do not have a medicinal effect or make medicinal claims are cosmetics and should comply with the regulatory requirements for cosmetic products. Guidance for retailers in respect of this is available from the HPRA website here:
General queries in relation to herbal medicinal products should be directed to: firstname.lastname@example.org.