Traditional herbal medicines – information for the public

Some plants contain herbs (herbal substances) that may be used to treat diseases. Medicinal products that are made from these herbs are known as herbal medicinal products.

A traditional herbal medicinal product (or THMP for short):

  • must be intended and designed for use without the intervention of a doctor.
  • must be taken orally or be for external use or for inhalation.
  • must not be administered by injection.

Some examples of herbs used in THMPs include devil’s claw, Echinacea purpurea, Ginkgo biloba and valerian. The botanical name for each herb used in a THMP is stated in the product information. For more information, see Herbal and homeopathic medicines for the full list of THMPs 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. 

THMP Legislation and Period of Traditional Use

THMPs have a notably long period of traditional use. Therefore, a simplified registration procedure called the ‘traditional-use registration scheme’ applies when registering THMPs. Each THMP is allocated a unique TR number which can be found on the product label and outer pack (if any).

Refer to Directive 2004/24/EC, for information on how to register THMPs in the EU.

THMPs registered under Directive 2004/24/EC and purchased by the public:

  • are produced to an appropriate quality standard.
  • are safe under the proposed conditions of use.
  • can be expected to act in accordance with an established tradition of use.
  • are appropriately labelled.

Please note that Directive 2004/24/EC does not cover:

  • Herbal medicinal products requiring a medical prescription
  • Injectable products
  • Food supplements and probiotics

Consumer Safety

As THMPs are intended and designed for use without the intervention of a doctor, patients must carefully read the patient information leaflet provided with the THMP before starting to use the product. The patient information leaflet contains important information on:

  • how to take the medicine
  • persons who should not take the medicine
  • precautions for use
  • potential interactions with other medicines
  • possible side effects

If patients do not feel better, or if symptoms worsen within the time specified in the patient information leaflet, a healthcare professional (e.g. a doctor or pharmacist) should be consulted. Patients should always remember to tell their doctor or pharmacist about any medication they are taking, including herbal medicines.

THMPs can cause side effects. If patients experience any side effects, they should talk to their doctor or pharmacist who can advise on any treatment that may be needed and can report the issue to the HPRA on the patient’s behalf. Patients can also report side effects directly to the HPRA, as follows:

  • Post: HPRA Pharmacovigilance, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland.
  • Phone:+ 353 1 6764971
  • Fax: + 353 1 6762517
  • Online: Visit the report an issue page.

By reporting side effects, patients help to provide more information on the safety of a medicine.

Herbal Products as Food

Herbal products may also be classified and placed on the market as food supplements provided they are not considered medicinal products and provided that they comply with the applicable food law. Herbal products marketed as food supplements should comply with Directive 2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. The Food Safety Authority of Ireland (FSAI) are the responsible authority for the regulation of food. All relevant queries should be sent to info@fsai.ie.

Further information

General queries in relation to herbal medicinal products can be sent to via our online contact form selecting 'Human medicines > Other queries' in the drop-down menu when promoted.