The Traditional Herbal Medicine Registration Scheme - Advice for pharmacists

Quick reference guide

Herbal remedies are made from plant materials and have been used for many centuries to treat disease or maintain good health. Unlike modern medicines derived from herbal products, such as digoxin, where the medicine contains a single active substance, herbal products contain a complex mixture of chemicals that are present in the plant material being used. Many of the compounds in herbal preparations can be shown to have pharmacological activity. Many different types of herbal medicine exist including Ayuverda, Kampo, traditional Chinese medicine and western herbal medicine. In many of these forms of herbal medicine, both herbal and non-herbal ingredients may be included; western herbal medicine generally only includes ingredients from herbal sources. Until relatively recently, the majority of herbal products available in the UK were not regulated which led to concerns about the quality and safety of some herbal preparations.

Traditionally, most herbal medicines available in the UK were unlicensed, a situation that was permitted through exemptions within two sections of the Medicines Act 1968. Section 12(1) of the Medicines Act 1968 allows unlicensed herbal remedies to be supplied to individual patients following a face-to-face private consultation, while Section 12(2) of the Medicines Act allowed the manufacture and supply of unlicensed herbal remedies without a consultation with a patient provided the product met specific exemption conditions.
   
However, unlicensed herbal medicines are not assessed by the Medicines and Healthcare products Regulatory Agency (MHRA) for quality and safety, and as a result, standards for unlicensed herbal medicines varied widely. There have been reports of unlicensed herbal medicines containing the wrong ingredient, or the deliberate addition of heavy metals or pharmaceutical drugs to herbal medicines. There are also reports of herbal ingredients being toxic, and of toxicity resulting from poor product quality.  

In 2004, a European Directive on Traditional Herbal Medicinal Products (2004/24/EC) was introduced. The Directive required any traditional herbal remedy that makes medicinal claims for its use to be either registered as a conventional medicine and obtain a marketing authorisation (i.e. demonstrate quality, safety and efficacy), or to be registered under a new Traditional Herbal Medicines Registration Scheme (THMRS). This new THMRS, which was introduced in October 2005, only requires quality and safety to be demonstrated, with efficacy being based on the traditional use of the herbal medicine, provided the claimed pharmacological effects are plausible.

Under the European Directive, Section 12(2) of the Medicines Act 1968 was revoked, and no new unlicensed herbal medicines could be placed on the market under this exemption after April 2004. However, the Directive provided for a seven year transitional period to enable the manufacturers of products currently marketed under the Section 12(2) exemption to submit an application and comply with the new requirements of the THMRS. The requirements of the Directive come into force in May 2011, at which time the transitional arrangement ended.

What will be the benefits of the THMRS?

The THMRS will ensure the quality and safety of herbal medicines available for self selection by patients. Under the THMRS, patients will have confidence that the medicine will contain the right ingredient which will be present in the stated quantity. As well as an assurance of quality, products will have a defined and recognised safety profile. By May 2011, all manufactured herbal medicines will be required to have either a traditional herbal registration or a product licence.

A further requirement of licensing under the THMRS is that product manufacturers must provide information on their product to a patient in the form of a patient information leaflet.


How does the THMRS address efficacy?

Any new herbal medicines wishing to obtain a marketing authorisation (product licence) will have to demonstrate the quality, safety and efficacy of the product, with efficacy demonstrated through data obtained from clinical trials.

For products registered under the THMRS, randomised controlled trials are not required to demonstrate efficacy. Permitted indications for these medicines are based on traditional use, provided the pharmacological effects are plausible on the basis of long-standing use and experience. An application under the THMRS will be refused if the data on traditional use are insufficient, or if the pharmacological effects are not plausible.

Within the THMRS, the traditional use of the herbal medicine means that it has been in medicinal use throughout a period of 30 years, including at least 15 years within the European community.


What types of conditions with can be treated under the THMRS?

Herbal medicines registered under the THMRS are suitable for use without medical intervention. They are used to treat minor conditions that are suitable for self medication such as the common cold, cough, sleep problems, migraine or low mood. Indications for serious conditions are not permitted within the context of the THMRS. 

Under the THMRS, products administered via the oral, external and inhalation routes may be licensed, but injectable preparations cannot be registered through this scheme.


How will I be able to tell if a product is a Traditional Herbal Medicine?

traditional-herbal-medicine-registration-certification-mark

All herbal medicines registered under the THMRS will include a number starting with the letters THR on the product container or packaging.

The Traditional Herbal Registration (THR) certification mark (see above) is a type of trade mark that indicates that a herbal medicine has been registered under the THMRS. This certification mark was designed as an additional visible symbol to help patients easily distinguish products registered through the THMRS. While the MHRA is recommending that manufacturers include the certification mark on their registered products, the use of the certification mark is not compulsory.


Will all herbal products be authorised as Traditional Herbal Medicines?

In March 2011, there were several hundred herbal medicines that held a marketing authorisation (product licence). The vast majority of these products had obtained a product licence of right (PLR) when the Medicines Act was introduced in 1968, and were subsequently given a product licence (PL) in the early 1990’s; for these products, claims for efficacy were essentially based on their traditional use. However, it is recognised that clinical trials have been undertaken for some herbal products.

Herbal medicines with a PL are currently being reviewed by the MHRA to assess whether they would be more appropriately covered by the THMRS, and some herbal medicines with a PL have already been transferred to the THMRS. 

Sativex spray, a herbal cannabinoid product, has recently been granted a product licence and some single herbal laxative medicines, such as those based on senna or ispaghula, will also retain their full marketing authorisations. However, due to the costs involved, it is unlikely that many manufacturers of herbal medicines will pursue full marketing authorisations. 

In addition, some herbal products that are considered to be non-medicinal may be regulated under food legislation; the Borderline Unit at the MHRA will make decisions on whether a herbal product is classed as a medicine or a food.


Will the new legislation affect product availability?

Any unlicensed herbal medicines previously made available through the Section 12(2) Medicines Act exemption can no longer be placed on the market after April 2011 unless they have been registered through the THMRS or obtained a marketing authorisation. New herbal medicines with less than 30 years use or less than 15 years use in the EU, or those not currently used, may not be granted a registration. Herbal medicines imported from outside of the EU are unlikely to comply with the new licensing requirements i.e. are not registered through the THMRS so cannot be made available for sale. Furthermore, some manufacturers of herbal products that could potentially be registered, may decide that it is not commercially viable to put their products through the registration scheme as the registration process is too expensive compared with potential sales.


Will unlicensed herbal medicines continue to be available from 1 May 2011?

Unlicensed medicines that comply with the requirements of Section 12(2) of the Medicines Act 1968 can be put on market up until April 2011, and can legally be sold by retailers until their expiry date or until the stock has been sold. However, an offence would be committed if a company (manufacturer, wholesaler or importer) placed further stocks of unlicensed medicine on the market after April 2011.

Also, unlicensed preparations can still be supplied under the Section 12(1) exemption i.e. can be supplied following a consultation with a patient.

When a patient requests advice about a herbal product, pharmacists should explain the difference between a registered and an unlicensed herbal preparation to enable a patient to make an informed choice. If asked by a patient to recommend a suitable manufactured herbal product, only registered preparations bearing a THR or PL number should be recommended. This is in line with MHRA advice that, where there is a licensed pharmaceutical product available on the market and available for use, then an unlicensed product should only be used if the licensed product is not suitable for the patient.


What messages should pharmacists give to patients about herbal medicines?

  1. Pharmacists should advise patients that the quality and safety of authorised herbal medicines bearing either a PL or THR number on the packaging will have been assessed by the MHRA. For herbal medicines with a THR number, efficacy will be based on their traditional use, although the proposed indications must be pharmacologically plausible. Efficacy does not have to be supported by randomised controlled trials, although clinical trials have been performed on some herbal products.
  2. Pharmacists should be aware that there will be herbal medicines on the market bearing a PL number whose efficacy has also been accepted on the basis of traditional use. These products currently have the wording ‘traditional herbal remedy’ on their packaging and they will undergo review to determine if they should be moved to the THR category. There will continue to be unlicensed herbal medicines available for retail sale after 30 April 2011, and up until the expiry date of these unlicensed medicines, although the amount of unlicensed medicines on the market will decrease over time as stock will not be replaced.
  3. Patients should be made aware that there is the risk of adverse effects with herbal medicines and the potential for interactions with conventional medicines. Most herbal medicines should be avoided in pregnancy and during lactation, and may not be suitable for young or old patients. Patients should also be reminded that although herbal medicines may be described as natural, herbal or derived from plants, this does not necessarily mean that they are all completely safe. In addition, it may be helpful to explain to patients the differences between herbal and homeopathic preparations as there is public confusion around the differences between these types of therapy.
  4. Patients should be advised that they should consult a doctor or qualified healthcare practitioner if their symptoms persist or if adverse effects other than those specified for the herbal medicine occur. If any unusual adverse effects do occur, reporting these to the Commission on Human Medicine (via the Yellow Card Scheme) either by the patient or via a qualified healthcare professional should be encouraged. If a patient has a reaction to a herbal medicine they should stop taking the medicine and inform a healthcare professional such as a pharmacist or a doctor.
  5. Patients should be encouraged to inform all healthcare professionals that they deal with that they are taking a herbal medicine. Patients should also be advised to continue taking their prescribed medicines in the way recommended by their healthcare professional while they are taking a herbal medicine. Any changes to a prescribed medication should only be done following a consultation with the patient’s prescriber.
  6. Patients should be encouraged to read the Patient Information Leaflet that will be included with a herbal medicinal product. Patients should also be reminded that as herbal medicines are medicines they should be kept out of the sight and reach of children. 
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