The Traditional Herbal Medicine Registration Scheme

Quick reference guide

This guide aims to explain to members of the Royal Pharmaceutical Society (RPS) the requirements and implications of the Traditional Herbal Medicine Registration Scheme (THMRS).

Key points

  • The requirements of the Traditional Herbal Medicine Registration Scheme come into effect on Sunday 1 May 2011
  • The quality and safety of herbal medicines bearing a Product Licence (PL) or Traditional Herbal Registration (THR) number will have been assessed by the Medicines and Healthcare products Regulatory Agency (MHRA) so these products will contain the correct ingredient, the right dose and will not be adulterated with other pharmaceutical materials or heavy metals
  • For herbal medicines bearing a THR number, efficacy is based on the traditional use of the product, whereas demonstrating efficacy as part of a PL application will require data from randomised controlled trials
  • In addition to a THR number, packaging may also have the Traditional Herbal Registration certification mark
  • Manufactured unlicensed herbal medicines, in stock in a pharmacy prior to Saturday 30 April 2011, which do not have a PL or THR number, will continue to be available for retail sale after Saturday 30 April 2011, up until their expiry date or until the stock has been sold
  • Only minor conditions suitable for self-medication can be treated
  • If a patient requests advice on a suitable manufactured herbal product, only authorised  preparations (i.e. those bearing a THR or PL number) should be recommended.

What are herbal medicinal products?

Herbal medicinal products are made from plant materials and have been used for many centuries to treat disease or maintain good health.  Many different types of herbal medicine exist including Ayuverda, Kampo, traditional Chinese medicine and western herbal medicine.  Unlike modern medicines derived from herbal products, such as digoxin, where the medicine contains a single active substance, herbal medicinal products contain complex mixtures of chemicals that are present in the plant material being used. Until relatively recently, the majority of herbal medicinal products available in the UK were not regulated.

Why was the Traditional Herbal Medicine Registration Scheme introduced?

Traditionally, most herbal medicines available in the UK were unlicensed products permitted by two exemptions in the Medicines Act 1968.  As they were unlicensed products, patients had no assurance of the quality, safety or efficacy of these preparations. The THMRS revokes one of these Medicines Act 1968 exemptions (Section 12(2)) and allows herbal medicines to be registered on the basis of their quality and safety, with efficacy being based on traditional use provided the claim for efficacy is pharmacologically plausible.

When was the Traditional Herbal Medicine Registration Scheme introduced?

The European Directive on Traditional Herbal Medicinal Products that described the THMRS was introduced in 2004, but a seven year transitional period was allowed to enable manufacturers of unlicensed herbal medicines to comply with the requirements of the THMRS.  This transitional arrangement ends on Saturday 30 April 2011.

How can herbal medicines now be authorised?

Herbal medicines can now be authorised through the THMRS and, if sufficient evidence is available to demonstrate efficacy, herbal medicines can also obtain a full marketing authorisation (product licence). Herbal products will also be available to the public as food supplements or cosmetics, and the decision about whether a herbal product is a food, cosmetic or a medicine will be made by the Borderline unit at the MHRA.

What are the benefits of the THMRS for patients?

The THMRS will ensure the quality and safety of herbal medicines available for self selection by patients, and determine that the efficacy is pharmacologically plausible. These products will contain the correct ingredient at the right dose and will not be adulterated with other pharmaceutical agents or heavy metals. In addition, a patient information leaflet must be provided by the manufacturer.

How is efficacy addressed in the Traditional Herbal Medicine Registration Scheme?

For products registered under the THMRS, permitted indications are based on traditional use of the preparation provided the pharmacological effects are plausible on the basis of long standing use and experience. Within the THMRS, traditional use means the herbal medicinal product has been in medicinal use for a period of 30 years, including at least 15 years within the european community. There is no requirement to demonstrate efficacy with data from clinical trials which is a key difference between a herbal medicine bearing a THR number and a conventional medicine with a PL number.

What conditions can be treated under the THMRS?

Herbal medicines registered under the THMRS can only be used to treat minor conditions that are suitable for self medication and do not require medical intervention such as the common cold, cough, sleep problems, migraine or low mood. The herbal medicines can be administered by the oral, external or inhalation routes only.

How can I tell if a herbal medicine has been registered through the THMRS?

All herbal medicines registered through the THMRS will include a number starting with the letters THR on the product container or packaging. The THR certification mark may also appear on the packaging (see left); although use of the THR certification mark is encouraged, its use is not compulsory.

Will unlicensed herbal medicines continue to be available after Saturday 30 April 2011?

Unlicensed herbal medicines that comply with the requirements of the Section 12(2) exemption of the Medicines Act 1968, but which have not been registered under the THMRS, can be put on the market up until Saturday 30 April 2011, and can be legally sold by retailers until their expiry date or until the stock has been sold. An offence would be committed if a company (manufacturer, wholesaler or importer) placed further stocks of unlicensed medicine on the market after Saturday 30 April 2011. In addition, unlicensed herbal medicines can still currently be supplied under the exemption in Section 12(1) of the Medicines Act 1968, but these can only be supplied following a face-to-face consultation with a patient.

What messages should pharmacists give to patients about herbal medicines?

  • That for herbal medicines bearing a THR number, efficacy is based on traditional use and pharmacological plausibility, and does not require efficacy to be demonstrated using clinical trials
  • There is the risk of adverse effects with herbal medicines and the potential for interaction with conventional medicines
  • Most herbal medicines may not be suitable for use in pregnancy or lactation; some herbal medicines may not be suitable for young or old patients
  • If a patient has an adverse effect to the herbal medicine they are taking, they should stop taking the herbal medicine and inform a healthcare professional such as a pharmacist or a doctor
  • Patients should be advised to continue taking their prescribed medication if they are taking a herbal medicine any changes to a prescribed medication should only be done following consultation with the prescriber
  • Encourage patients to inform healthcare professionals that they are taking a herbal medicine
  • Patients should be advised to consult a doctor or healthcare practitioner if their symptoms persist.

Where to go for further information

RPS RESOURCES

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