Information for the Public

Some plants contain substances that may be used to treat diseases. Medicinal products that are made from these substances are known as herbal medicinal products. Even though they are natural, a number of these products may be dangerous for patients. This is why they are covered by pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products.

A traditional herbal medicinal product (THMP) must:

• be intended and designed for use without the intervention of a medical practitioner
• be taken orally, for external use or inhalation (not administered by injection)
• be administered exclusively at a specified strength and dose
• be on the market for a ‘period of traditional use’

Some examples of herbs used in THMPs include devil’s claw, valerian, Echinacea purpurea and Ginkgo biloba. The botanical name for each herb used in a THMP is stated in the product information, as this is a more exact way of naming and identifying the plant. See THMPs currently registered by the HPRA.

THMP Legislation and Period of Traditional Use

Medicinal products, including herbal medicinal products, normally need a marketing authorisation to be placed on the EU market. However, THMPs have particular characteristics, notably their long tradition of use. To take account of this, the EU has introduced a simpler registration procedure for them, while continuing to provide the necessary guarantees of quality and safety. Such a registration is called a traditional-use registration and each THMP is allocated a unique TR number which can be found on the product’s label and outer pack (if any).  

The Herbals Directive (Directive 2004/24/EC) was adopted to facilitate the marketing of THMPs in the EU. The Herbal Directive ensures that THMPs 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.

The simplified procedure allows the registration of THMPs without requiring evidence of clinical efficacy (evidence that applicants must provide under the marketing authorisation procedure). The traditional use of a medicinal product makes it possible to replace this requirement with evidence that the efficacy of a product is plausible on the basis of long-standing use and experience. Applicants must provide sufficient evidence of the medicinal use of a product for a period of at least 30 years, including at least 15 years in the EU.

A full review of published safety data and an expert report must be provided. However, even a long tradition of use does not exclude concerns about a product's safety. Therefore the HPRA may request additional data when assessing the safety of the herbal medicinal product. This is to ensure that registered THMPs will not be harmful under their specified conditions of use. 

The quality of a medicinal product is independent of the period of time for which it has been used. Therefore, the normal quality requirements that apply to all authorised medicinal products apply equally to THMPs.

The Herbals Directive does not cover:

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

Customer Safety

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

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

If patients do not feel better, or if symptoms worsen within the timeframe 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.

Like all medicines, THMPs can cause side effects, although not everybody gets them. If patients get any side effects, they should talk to their doctor or pharmacist. Healthcare professionals can advise on any treatment that may be needed and can report the issue to the HPRA on a patient’s behalf.

Patients can also report side effects directly via post to HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Ireland. Or contact us via Tel: +353 1 6764971 / Fax: +353 1 6762517 or E-mail:medsafety@hpra.ie 

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

Herbal Products as Food

Herbal products for which medicinal claims are made, or which contain active substances in sufficient amounts to have a medicinal effect, are medicinal products. Medicinal products cannot be placed on the market without either a marketing authorisation or, in the case of THMPs, a certificate of traditional-use registration from the HPRA.

Herbal products may be classified and placed on the market as food supplements provided they do not fulfil the definition of a medicinal product and comply with the applicable food law. In particular, herbal products marketed in the form of 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 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).

Further information

General queries in relation to herbal medicinal products can be directed to info@hpra.ie.