Medicines: Traditional Herbal Medicine

These regulations affect companies who wish to manufacture over-the counter traditional herbal medicines. The purpose of the regulations is to allow consumers to make an informed choice of over-the-counter medicines made to assured standards of quality, safety and patient information.

The new European Traditional Herbal Medicinal Product Directive 2004/24/EC came into effect on 30 April 2004. The aim of this Directive is to remove the differences which create obstacles to the free movement of medicinal products in the European Union, while ensuring protection for public health. This has been done through requiring each EU country to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision.

We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections.

You can find the regulations that relate to Traditional Herbal Medicines to the left below.

Please note that some regulations in the medicines section also apply to herbal medicines.

Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977, SI 1977/2130

Specifies the classes of herbal remedies of which the exemptions from the restrictions stated in the Medicines Act 1968 do not have effect.

Read More… (opens in a new window)

 UK regulation

Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005, SI 2005/2750

Amends Traditional Herbal Medicines Products regulations. Measures relate to registration procedures, exemptions, labelling requirements and introduction of offences and penalities for breach of these regulations.

Read More… (opens in a new window)

EU regulation

Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006, SI 2006/395

This instrument amends the Medicines (Retail Sale or Supply of Herbal remedies) Order 1977. The instrument corrects an error in an amendment to that Order made by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750) (“the 2005 Regulations”).

Read More… (opens in a new window)

EU regulation

Medicines (Prohibition of Non-medicinal Antimicrobial Substances) (Amendment) Order 1992, SI 1992/2684

Amends the Medicines (Prohibition of Non-medicinal Antimicrobial Substances) Order 1997 to allow the sale and supply of specific antimicrobial substances in medicinal products or animal feeding stuff in certain circumstances; laying down the animal health requirements for EU trade; importing of semen of domestic bovine or porcine animals; and permiting the use of streptomycin and eight more substances as preservatives in products used for artificial animal breeding.

Read More… (opens in a new window)

 UK regulation

Medicines (Prohibition of Non-medicinal Antimicrobial Substances) Order 1977, SI 1977/2131

Exempts certain antimicrobials from the prohibition of sales and supply.

Read More… (opens in a new window)

 UK regulation

Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008, SI 2008/548

Prohibits the sale, supply or import of any medicinal product for human use containing the Senecio plant species under Section 62 of the Medicines Act and amends three existing Orders to ensure that an exception for goods in transit applies to goods imported from an European Economic Area state which are to be exported to a third country, or an European Economic Area state other than the United Kingdom.

Read More… (opens in a new window)

 UK regulation

Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001, SI 2001/1841

Prohibits the sale, supply or import of any medicinal products for human use containing a plant belonging to the genus Aristolochia or from a number of other named species or extract from such a plants, unless certain exceptions apply.

Read More… (opens in a new window)

 UK regulation

Medicines (Bal Jivan Chamcho Prohibition) (No 2) Amendment Order 1997, SI 1997/856

Removes the prohibition on the impotation, but not the sale and supply, of the medicinal product known as Bal Jivan Chamco when it is imported from or originates in the European Economic Area.

Read More… (opens in a new window)

 UK regulation

Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977, SI 1977/670

Prohibits the sale, supply and importation of a medicinal product for a baby tonic under the name of BAL JIVAN.

Read More… (opens in a new window)

 UK regulation

Medicines (Chloroform Prohibition) Order 1979, SI 1979/382

Prohibits the sale or supply of medicinal products which are for human use consisting of or containing chloroform, and provides exemptions from the prohibition including the sale or supply of chloroform as an anaesthetic, for export or for use as an ingredient, in specified circumstances, in the preparation of a substance or article.

Read More… (opens in a new window)

 UK regulation

Medicines for Human Use (Kava-kava) (Prohibition) Regulations 2002, SI 2002/3170

Prohibits the sale, supply or importation of any medicine which consists of a plant or plant extract belonging to the species Piper Methysticum (Kava-Kava) the exceptions being where it is for external use, the enforcement of Medicines Legislation and imported or exported to an EEA state other than the UK and where it is subject to product licence, marketing authorisation or homeopathic registration.

Read More… (opens in a new window)

 UK regulation

Medicines (Phenacetin Prohibition) (Revocation) Order 1996, SI 1996/3269

Revokes the Medicines (Phenacetin Prohibition) Order 1979 which prohibits the sale and supply or import of any medical products containing Phenacetin subject to exemptions.

Read More… (opens in a new window)

 UK regulation

Medicines (Stilbenes and Thyrostatic Substances Prohibition) (Revocation) Order 1997, SI 1997/1727

Revokes the Medicines (Stilbenes and Thyrostatic Substances Prohibition) Order 1982 as part of the implementation by the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997 of Council Directive 96/22/EEC which relates to the banning of the use in livestock farming of certain substances having a hormonal or thyrostatic action and of beta-agonists.

Read More… (opens in a new window)

 UK regulation

Herbal Medicines Advisory Committee Order 2005, SI 2005/2791

Establishes the Herbal Medicines Advisory Committee to advise on issues relating to herbal medicinal products.

Read More… (opens in a new window)

 UK regulation

Tell us what you think should happen to these regulations and why, being specific where possible:

206 responses to Medicines: Traditional Herbal Medicine

  • T.Nouve said on April 10, 2012 at 2:09 am

    Legislation of herbs that makes certain species illegal or inaccessible to the public (without an expensive hour-long consultation) is ridiculous. It’s like a legislation ruling that we are longer allowed to cook with certain fruit or vegetables such as rhubarb incase we break out in a rash or accidentally kill ourselves (maybe we should ban chopping knives too). If it really IS about protecting the public why can I go to a chemist and buy pseudoephedrine over the counter?

  • Ashvinprasad Merai said on April 9, 2012 at 7:48 pm

    There is a big burden on NHS. Ayurveda provides alternative medicines. It has been practiced for thousands of years in India and elsewhere and has been proved to work. Therefore the government should not ban it.

    Comment Tags: less burden on NHS

  • Patricia Gallagher said on April 9, 2012 at 1:44 pm

    I had assumed this Red Tape Challenge was designed to hear comments about the THMPD and how it could be improved (made easier) therefore I am surprised to read the unhelpful comments about scrapping the legislation.
    The THMPD legislation is crutial for herbs and for consumers and practitioners as it allows sale of herbal products whose safety and quality has been reviewed and a Patient Information Leaflet included.
    My reply to those who are asking for the THMPD to be scrapped is ” when are you going to wake up and realise that this is law and EU law, it is not going to go away? Companies had 7 years to get products registered but some have chosen not to, one might ask why they don’t want their products scrutinised. ”

    What we need:-

    1. The MHRA to publish a list of herbs which can only be sold as medicines (such as St John’s Wort, Echinacea, Milk Thistle and Black Cohosh) and can not be allowed in food supplements at any strength/quantity. This would avoid the huge confusion in the market place.

    2. The MHRA to enforce the law by prossecuting those producing medicinal herbs without a registration.

    3. Reduction or scrapping of pharmacovigilance where use of a herb is well documented.

    4. Allow several extract suppliers to be added to THR registrations, even if the source is not used often, as the European extract suppliers for THRs have a stranglehold on supply and are charging artificially inflated prices. We need ease for adding new extract suppliers.

    • Deiter said on April 9, 2012 at 7:58 pm

      Is “Choice” to trump patient safety? Herbals, as purveyed at this time, have no measure or requirement of purity or strength, let alone proven efficacy!

      Comment Tags: lack of purity

    • Philip Evans said on April 10, 2012 at 9:32 am

      Patricia Gallagher wrote ” when are you going to wake up and realise that this is law and EU law, it is not going to go away?”. This means she is apparently oblivious to the fact that the preamble to this consultation on the regulations asks the question (quote) “Should we scrap them altogether?”

    • Daniel said on April 10, 2012 at 4:30 pm

      Patricia the vast majority of comments on here are far from being unhelpful, they clearly show the myriad flaws in THMPD legislation – they may be unhelpful to supporters of Big Pharma however.

      Comment Tags: big pharma thmpd

  • William LaChenal said on April 9, 2012 at 3:42 am

    Whilst I’m here, as a serious parting thought, have there been any cast-iron DBPCRCTs that prove the breathing of air is beneficial to human health?

    If not (and before somebody else does so), I would like to apply for a research grant with a view to gaining the exclusive EU permitted claims licence, and thereby lay claim to all use & provisions of said gaseous substance (for a small fee, of course, taxes payable to HMG R & C).

    Comment Tags: AIr, Tax, theft, THMPD

  • William LaChenal said on April 9, 2012 at 3:31 am

    I seethe THMPD as an ill-conceived and badly-implemented (and very possibly corrupt) gross denial of the natural sovereign rights of the peoples of Europe.

    Whilst we have given over our sovereignty as a nation to this trade organisation, we are compelled to accept their corrupt edicts. It would still be nice if they would pass audit, even once.

    So, we shall have to follow through in accepting this state piracy, this Napoleonic confiscation of our natural birthright, this underhand attempt at prohibiting natural remedies, this creeping process akin to boiling a frog, this intent that because it is implemented so slowly we shalln’t notice until it is altogether too late.

    However, we perhaps have some flexibility in the final implementation into UK law, to give it a nice coating of rust rather that gold-plate.
    I have often said that the EU would be much better for Britain if we gave it same respect as do the French – that is to say, when the French do not particularly like a directive, they just, well, ignore it.

    I am anxious to avoid maverick (skeptic-induced) “crackdowns” on suppliers of perfectly innocuous substances which inconvenience large pharmaceutical corporations by callously making people well & rendering them in no further need of profitable medicines.

    To that end, I would suggest that before any such enforcement action, an agency must prove a case at law, beyond doubt, that there is direct harm to human health from the criticised product or advice.

    Further, any confiscated items must not be destroyed, but kept safely pending ultimate appeal, and that a compensation scheme be in place (within the responsible agencies’ budgets) for business losses due to wrongful closure or seizure.

    That should do.

    Comment Tags: crackdowns, state piracy, THMPD

  • Sally Viney said on April 8, 2012 at 6:28 pm

    THMPD has to be one of the most unpopular directives to come out of Europe. The only winners are large companies with enough capital to buy into the scheme hoping to corner the market as smaller (possibly more ethical) companies go out of business. THMPD can only limit people’s choice. Issues of safety do not stand up to scrutiny, the law as is stands should be enough without THMPD being enacted. Scrap it altogether.

  • subhash Tank said on April 8, 2012 at 2:27 pm

    pls for God.s sake get rid of these legislation as it is only a ploy for big pharmacutacal firms to have No Challenge /Choice for ordinary citizen but to buy what they throw at us and which all of them have so many dangerous sideffects that costs lives and money .

  • julie kinsella said on April 8, 2012 at 11:21 am

    Legislation can make many things very confusing and segregetes many issues. I am an aromatherapy student and would love to know how this would impact on the use of Essential Oils. The oils come from the same plants as the traditional herbal medicines. I have huge concerns that this legislation will kill aromatherapy practice within the UK. Its disgraceful that legislation is being sought when these practices have been around for thousands of years. If they were wrong or harmful then they would not have lasted for so long. Proof of efficiacy is there. The only proof we can truely have is time, TCM and use of herbs have lasted the test of time and that is the best standard we can have. How many allopathic treatments get withdrawn as the test of time shows them to be unrelieble or have lethal side effects. I would much rather have TCM than western allopathic treatments.

  • Maureen Knight said on April 8, 2012 at 9:44 am

    I am very concerned that new legislation will prevent me from using alternative therapies ie herbs, minerals and vitamins. In my opinion alternative therapies are less potent and therefore less dangerous than mainstream drugs. I have no wish to dictate to others what they should or should not take but I feel strongly that I should have the option of healing myself when necessary with herbs, tinctures and vitamins that I feel would benefit me. Many people say that much of medicine relies on the placebo effect. I prefer my placebo to be a substance of my choice that I have researched for myself. In general I feel alternative therapies are gentler an kinder to the whole person.

    Comment Tags: Alternative choice.

  • Paul Richards said on April 8, 2012 at 9:31 am

    I am a grower of medicinal herbs on the Welsh Border and next year we will be celebrating 30years of growing on our herb farm. We have produced 30 different herbal tinctures using fresh herbs grown on the farm, and the tinctures are made and bottled under Pharmaceutical GMP by a herbalist with a small manufacturing unit. I am a trained botanist and we provide tinctures with full traceability and authentication of herbal material.
    Our tinctures are as good as any with a THR, the only difference being one of red tape. We cannot afford the cost of running stability tests, producing a dossier and all the other peripheral requirements for each product needing a THR registration. Additionally, our tincture maker cannot afford the extra requirements to achieve a full Manufacturer’s Licence – so any product for which we achieved THR status would need to be packed elsewhere.
    We need to cut out the red tape and insist only that products have full traceability and authentication of the raw material and the product be made under Pharmaceutical GMP. A THR registration would not produce a product with any greater safety than this.
    The result of the legislation is that a major part of our small business is lost, along with a significant part of the business of our manufacturer. Additionally, the market will have a drastically reduced choice of OTC herbal medicines available to buy.
    Let’s be honest – a tincture produced by us with a THR Registration would be identical to that we have been producing for many years. The only difference is that we can’t afford the cost so it will be lost – killed by red tape.

  • virupaksha gupta said on April 8, 2012 at 9:20 am

    Traditional practices were running since centuries regulation can not stop their existence. If some one thinks they are non existence it is the ignorance of themselves. But Regulation is needed for certain extent, but it should be by the body which governs by the traditional practitioners. But not by allopaths as their attitude is clearly empathetic.

  • m a padmanabhan said on April 8, 2012 at 7:07 am

    no legislation is necessary. AYURVEDAM is being used in india from more than 2000 years ago

  • Barbara Beck said on April 8, 2012 at 6:17 am

    Legislation is unneccessary.
    You cannot improve what doesn’t exist

  • Barbara Beck said on April 8, 2012 at 6:07 am

    Legislation is unneccessary.
    You cannot improve what doesn’t exist.

    • Cancel said on April 8, 2012 at 9:05 am

      ?….

  • Lu Parfitt said on April 7, 2012 at 11:28 pm

    Europe leave well alone

  • Dr. Rajan Naik said on April 7, 2012 at 7:25 pm

    To my experience it is not some body who needs or anybody does not need Ayurveda. Ayurveda is life style. it is not just some herbal or mineral medicines. Ayurveda medicines can not be standardized as every person is unique. cause of disease is not standard. in my 30 years of practice i have found that every medicine has to be made according to patients life style, constitution, his or her place of nation & so many. So many ailments are related to eating habits. Major part of ailments are generated by everyday added non eco friendly chemicals been been added to human life which creat complication in human system, which kill patient but surves DOCTOR. Allopathy is total failure, but due to strong lobbying other therapies are not been understood by people which is necessary for human life.

  • Ian Jackson said on April 7, 2012 at 6:19 pm

    As a pharmacist and medical herbalist I have a foot in both camps. Some of the opponents of herbal medicine argue that the THM regulations need tightening up to include proof of efficacy as well as safety. That is fine but first can we ensure that all conventional medicines have primary end point data and not just data from surrogate markers. This means that all medicines that are used in type 2 diabetes (apart from metformin and glibenclamide) need to be removed from the market. The flu vaccine in the over 65′s doesn’t have any endpoint data so needs to be removed as well. So before the usual suspects start looking at herbal medicines lets have a look at conventional medicine first where many drugs have a poor evidence base and have the potential to do considerable harm.

    • virupaksha gupta said on April 8, 2012 at 9:26 am

      Reality check.
      I appreciate you comment sir.
      Traditional practice the term itself tells which is established by experiences through generations. Experimental sciences are less truth before experience based sciences.

  • Richard Middleton said on April 7, 2012 at 5:08 pm

    I write these comments below as a registered pharmacist who has worked with allopathic and natural medicines since the 1970s. These regulations were introduced in order to improve public safety, whilst ensuring that the general public were able to obtain a wide choice of herbal medicines. The regulations ensure that consumer choice to use a herbal medicine is based on reliable, independent information so that inapropriate or unsafe use can be avoided. Many companies, large and small, have engaged in the regulatory process and obtained approvals. Meanwhile, a vociferous minority of companies have refused to do so on the grounds that these public safety issues are flawed and the Directive is unnecessary. The future safety of UK consumers is being undermined by either an unwillingness or inability on the part of the MHRA, to enforce this Directive in the face of this vociferous minority. Whilst uni-component herbal medicines are able to comply with the Directive, it is more challenging to achieve registration of multi-herbal component products. It is therefore essential that, in parallel with enforcement of this Directive, statutory regulation of medical herbalists is expedited by govrnment, in order that it is possible for more complex herbal medicines to be supplied through medical herbalists in the future.

    • Belfast herbalist said on April 8, 2012 at 10:41 am

      Richard, I can appreciate your perspective but these regulations were not introduced to improve public safety and to ensure that the general public can obtain a wide choice of herbal medicines. In the latter, choice has actually been restricted while in the former the safety argument is greatly exaggerated, betraying a lack of understanding of whole herb use (as opposed to isolated active ingredients derived from herbal products which should indeed be considered as pharmaceuticals and trialled accordingly to that perspective) but putting whole herbs in the same bracket as pharmaceuticals is bad science and undermines much of the reasoning behind THMPD from the aspect of public safety. In this instance the pharmaceutical model and worldview, is being given precedence to traditional systems which have been around an awful lot longer – while the safety record of the pharmaceutical model by comparison to herbal medicine suggests that it seriously needs to get its own house in order before it goes knocking at other doors.

      Statutory regulation of medical herbalists by the way will lead to the effective criminalization of traditional herbalists by the same remit. Hence the outcry.

  • plescan irina said on April 6, 2012 at 12:03 pm

    It is not possible to treat herbs in the same way as alopathic medicines. The herbs have thousands of active principles, they are different in species and in constituents from a place to another, so the idea of standardizing and studying in the same way as a chemical substance is not sustainable. So, if we talk about pure herbs and not extracts, they should be freely sold/used, except for the toxic species which are well-known. A medical system that has been used for thousands of years does not need clinical studies to be proven. If we talk about herbal extracts, then studies, documents, files would be required as they could act differently (in large doses, regarding side effects)from the mother herb and from the traditional uses.

Bookmark and Share