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.

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 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.

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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”).

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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.

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 UK regulation

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

Exempts certain antimicrobials from the prohibition of sales and supply.

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 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.

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 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.

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 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.

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 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.

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 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.

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 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.

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 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.

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 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.

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 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.

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 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

  • Annette Young said on April 3, 2012 at 2:26 pm

    I think that it should be scrapped full stop. I am all for making herbal treatments safe for all but we all know that these changes are a money making operation by the pharma companies. I have no faith in the pharma companies or the products that they supply. There are often masses of side effects and these are still knowingly distributed to the general public. Health is a personal and important issue. In the past I have suffered from side-effects from traditional medicines and the thought of the pharma companies having a greater involvement in natural medicines is quite frankly horrifying. I am also concerned that it is going to cause greater suffering to animals as they will surely be tested on as a result of this legislation going through.
    I have found certain herbs through careful research that have made a huge difference to my life. I tried the medical route and it failed for me several times.
    Many companies [text deleted] ensure that they only produce quality natural products but really the general consumer should be able to make a choice as to where they buy the herbs that work for them and not to have any restrictions placed upon them.
    I have no doubt that this is purely a money making exercise and shame on the governments for enforcing narrow minded beliefs onto those who believe in the natural products and who buy from reputable companies.
    Do you realise that by the removal of any ‘natural product’ and replacing with a so-called pharma tested version, that you are subjecting possibly some greater health problems, pain or discomfort on those who have already found their own natural ‘cures’ and who do not wish to have to search outside of the EU to buy them. In the current financial climate, surely it makes sense to back reputable natural health companies who operate inside of the EU?
    Please have some common sense and think about the people within the EU who do not wish to have their rights to self-medicate naturally taken away from them.
    Drugs and herbs are not the same. Those who seek a gentler solution choose herbs, those who don’t know better, choose chemically based drugs created by the pharma companies.
    Everyone has the right to choose based on their own needs, what right does the governments have to decide otherwise?
    If you wish to make changes to legislation, it might be an idea to investigate the pharma companies methods instead. This is long over-due in my opinion.

  • sue budd said on April 3, 2012 at 2:11 pm

    scrap it alltogether, there are far more dangerous drugs over the counter than simple herbs, i have used herbs for 25 years, on my family and animals, and stoptelling us what to do/

  • Geoffrey Grey said on April 3, 2012 at 1:22 pm

    I would like to see this legislation removed from the books. It is biased, ineffective and I am convinced, has been engineered by pharmaceutical companies and perhaps, as has been suggested, also large health companies, although I cannot think that they would welcome having to pay expensive license fees merely to put smaller companies out of business. This is the sort of legislation devised by bureaucrats who have neither knowledge of how natural treatments work, nor how the medical profession uses bullying tactics and fear to persuade vulnerable patients to take prescribed medication which in many cases proves lethal. The medical profession, although fulfilling an essential part in the nation’s health and providing a very valuable service in many respects, has become corrupted in many of its treatments by large, powerful pharmaceutical companies. The Hippocratic Oath seems to have been thrown out of the window, especially the clause which states that the practitioner “do no harm to the patient”. Patients, who would otherwise have been treated in a simple and effective manner, are on many occasions used merely as guinea pigs and their justified questioning of their treatment totally ignored.
    It is also barbaric that remedies which have been proved effective over long periods of time should be demonised to make way for some concoction brewed in a laboratory and tested on unfortunate animals. I think the procedures, corporate secrecy, and methods of promoting pharmaceuticals should be subjected to close scrutiny, and the herbal remedy community should be left to get on with what they were doing perfectly well until this unwarranted interference by Brussels.

  • Alison Townsend said on April 3, 2012 at 1:18 pm

    How does one “manufacture” a herbal remedy? This legislation is a direct affront to people’s civil liberties and freedom of choice. It is badly written and serves Big Pharma only. The only improvement that can be made is to scrap them altogether.

  • Catriona Stewart said on April 3, 2012 at 7:00 am

    I would like to see companies of the size that can afford to produce and market so-called herbal remedies of dubious provenance and content stopped from doing so. This legislation does will not achieve that purpose, all it will do, as others have pointed out, is allow those with the finances behind them to purchase a licence to get their products out on the shelves, while sole-traders and small businesses with good quality therapeutic standard herbal remediies and other products will no longer be able to supply their market or make a living.

    Comment Tags: “inequitable”

  • Ross Clement said on April 3, 2012 at 6:32 am

    Traditional Herbal Medicine must be held to the same standards of proven efficiency and effectiveness as “normal” medicines. if any claims are to be made about medicinal worth, these must be backed up by proper research including statistically valid double blind randomised clinical trials. It is vital that removal of “red tape” doesn’t allow the sale and advertisement of ineffective medicines which claim to be effective, as great harm can be done.

    • Belfast Herbalist said on April 4, 2012 at 8:13 am

      No there needs to be a clear understanding of the difference between isolated ingredients and whole herbs – treating a whole herb as a pharmaceutical betrays a lack of understanding of herbal medicine and is very poor science.

    • martin watt said on April 5, 2012 at 11:58 am

      This idea that all drugs are tested is simply not correct. It only happens with modern drugs. It has never happened with older remedies used by doctors for generations. A great example is aspirin, only in recent years has it become apparent that it is the best drug since sliced bread, but where are the clinical trials needed for marketing purposes?

      Comment Tags: drug testing

  • Hanne Stinson said on April 2, 2012 at 7:51 pm

    Stringent testing of efficacy and potential harm is required for any pharmaceutical. This helps ensure that only effective medicines can be sold or prescribed, and that harmful side effects are identified. I can see no reason to treat herbal remedies differently: if they seem to be effective (as some probably are) they should be tested in exactly the same way as other medicines before being sold/prescribed. If they are effective, they stop being ‘alternative’ – they are medicines and should be treated like any others.
    It should be unlawful to market any herbal ‘remedy’ that has not been subject to the same testing as ‘conventional’ (i.e. real) medicine.

    • charles Buck said on April 3, 2012 at 8:19 am

      Many correspondent appear to presuppose that “real medicines” are by definition proven by existing processes to be safe and effective. This simply not true>
      People assume that NHS medicine is proven and evidence-based when this is simply not the case. In 2006 the EBM website clinicalevidence [text deleted] – run by the BMJ – tells us that only 15% of current treatments can be rated as “beneficial”, 48% were classed as having “unknown effectiveness”. (derived from New Scientist 5th August 06 p 20)

      It is also often assumed that having government regulatory process in place that drug medicines are generally safe. Drug companies are now the world’s most harmful industry its products are now more lethal than traffic accidents, killing 37,485 Americans in a year, 1200 more than were killed on the roads.

      According to a report in the Lancet, the European Commission estimated that 197,000 EU citizens died as a result of licensed medicines in 2008. (Lancet June 2011). Correspondents are very misinformed when they claim that licensed drugs are safe and effective.

    • Philip Evans said on April 3, 2012 at 11:29 am

      Logically speaking, there is certainly every reason to treat natural, herbal remedies differently from artificial, manufactured medicines, because they are totally different, in that the herbs grow all around us, just as do the plants we use as foods.

      Comment Tags: artificial, natural, THMPD

  • Bob K said on April 2, 2012 at 7:14 pm

    This legislation could be scrapped and merged into legislation covering real medicine.

    All medicine should be treated equally. It either works or it doesn’t work. If herbal medicine needs special treatment and exemption then it doesn’t work, it isn’t medicine and it shouldn’t be being sold as such.

  • Chris Caton from said on April 2, 2012 at 6:44 pm

    I make this submission on behalf of the 7,269 people who are signatories to the “Save our Herbs’ petition, the text of which reads as follows:
    “We the undersigned strongly object to the Government’s proposals to statutorily regulate herbalists and change section 12(1) of the 1968 Medicines Act.
    We also oppose the abolishing of section 12(2) of the 1968 Medicines Act to be replaced by The Traditional Medicines Registration Scheme by 2011.
    These proposals have been heavily influenced by the pharmaceutical industry, which stand to gain by the proposals. Any new state regulation requires that a sufficient risk can be demonstrated to prove the need for regulation, there is not any evidence to prove that herbalists or herbal medicine present a significant risk to the public under previous and present legislation, when policed properly.
    These proposals will reduce access, increase costs, decrease patient choice, encourage a black market and send experienced herbalists underground, crucify our indigenous tradition and diversity of available healthcare. At a time when we face urgent environmental problems, herbal medicine provides some of the answers only if it remains a ‘people’s medicine’, simple and freely accessible.
    Herbal medicine does not belong to herbalists or pharmaceutical companies, the public should be educated and encouraged to use traditional herbal medicines for minor health problems, not immobilised by a state of fear.”

  • Danielle Binding said on April 2, 2012 at 4:29 pm

    I am appalled and gravely concerned by the disproportionate and unfair measures proposed by this and other related European Directives and regulations, including the Nutrition and Health Claims Regulation (NHCR).

    As someone who works in the health supplements industry, both the proposed restrictions and those that have already been implemented are placing thousands of UK jobs and reputable and respected businesses at risk. They also represent a major threat to (i) our human rights to choose what we eat and what we put into our bodies and (ii) our freedom of speech, to tell consumers the facts about natural health products and their benefits.

    Our business has already been severely affected by the implementation of the THMPD earlier this year, which has stopped us from selling products and ingredients that have been used safely for many years. As a result, we are being placed at a disadvantage as against our competitors in other countries and it is destroying the industry within the UK.

    We recognise that there are good reasons for drugs to be tested and licensed. They are chemicals the body has never experienced before and can kill. The reason we have been using herbal remedies for millennia is that, correctly prescribed, they generally work. Indeed, as sold under food law (until April 30 2011) they had to be safer than a slice of bread! No deaths have been recorded due to herbal remedies properly sold under food law for over 40 years. Objectively, there is really no case to subject herbal remedies to a similar regulatory structure to pharmaceuticals.

    In contrast properly licensed drugs are, despite all attempts to regulate away risk, a big killer. Over 40,000 deaths are recorded in the UK alone. This is a well-known problem in the medical profession. It is a nonsense to attempt, as the EU is doing, to regulate natural herbs, used since time immemorial, as though they were licensed drugs. It is difficult if not ridiculous to patent natural substances, so companies cannot afford to do safety studies – they will not recoup their investment!

    The only side to benefit from this raft of legislation is the pharmaceutical industry. Herbal medicines are now part of an industry that is valued at more than £3billion a year. Herbal remedies are not some tiny niche market: a quarter of the adult population in the UK buys them. This is why the big pharma are working so hard to take over this industry and squeeze natural health business out.

    Heavily lobbied by the pharmaceutical industry, the European Food Safety Authority (EFSA) is making it impossible for small businesses in the health supplements industry to survive. It has rejected 95% of claims for plant-based foods. This is basically censorship – we are being prevented from informing 500 million European citizens about the health benefits of food. Without a voice to talk about our products, our businesses will no longer be viable.

    The regime proposed by THMPD, NHCR and the other related legislation disproportionately benefits large corporations and has the potential to cripple SMEs, because a) many previously allowed claims will be lost; b) it will be harder for smaller companies to differentiate products, and; c) randomised clinical trials are prohibitively expensive and, in relation to herbal supplements, unnecessary.

    The THMPD and NHCR are apparently intended to offer a high level of consumer protection, but since all products containing the same ingredients will be forced to make the same claims, and claims will only be allowed where EFSA has established a causal relationship (very difficult in the case of most foods and ingredients), consumers will find it almost impossible to distinguish between different products and make informed choices that are personally relevant. Instead, what we have is a regime that creates “a passport system for big business”.

    As a result of the EU’s meddling, we will be left with a much reduced choice of herbal remedies and supplements and little if any information to base consumer decisions on. How does that protect the consumer, who will simply buy their supplements online from overseas companies that are subject to less regulation?

    The EU Directives constitute a significant regulatory burden. Already many shops and websites specialising in natural remedies have either closed or emigrated outside the EU – the US is one destination. How does this benefit an already unstable UK economy?

    Under this regime, everyone loses – except the pharmaceutical industry!

  • Seventh Wab said on April 2, 2012 at 2:07 pm

    It is not an overstatement to state that this European Directive is a tragedy for human rights, human health and consumer choice. Consumer safety is being compromised not improved. From a business perspective, a vibrant, innovative and important section of the UK economy has been completely stifled. And considering the economic climate, the THMPD is an absolute disgrace.

    As a proud British company working to Good Manufacturing Practice (GMP) standards, and exceeding the requirements of a vast range of national legislation, we have now sold out of four impeccable quality herbal supplements under the “sell through” period. Another 8 will follow. These are mainstream herbs with an outstanding safety record of many hundreds of years of use. We could not afford the £1.4 million simply for the REGISTRATION of these products (just in the UK, this would not apply to the rest of Europe). On principle, had we been in such a fortunate position, we would not pay lip service to this disproportionate, unfit for purpose legislation (and double prices to customers because of it).

    Our herbs were additive free, whole herb, GMP assured, and grown to organic standards with full traceability from seed to factory – we could not raise the quality bar any higher. They have been replaced largely by the inferior offerings of German and Swiss Pharmaceutical companies (creating an unfair oligopoly marketplace), typically in extract form in a polymer base, and packed with undesirable additives. Quality has been entirely compromised in the name of red tape, and both British business and consumers are suffering because of it. If any British legislator can even begin to justify this, we would love to hear it?

    Overall, in all cultures across the World and throughout history, Herbal Medicine has an impeccable safety record. It is a shame the same cannot be said for pharmaceutical medication and medical devices. And this directive is nothing short of xenophobia when it comes to the traditions of for example, Chinese and Ayurvedic herbal medicine. These cultures have a fine, long standing, safe use of herbs, yet many of these herbs will be entirely removed because they have not had 15 years of use in the EU.

    We wholeheartedly support improving quality standards. But in fact, effective enforcement of exisiting national legislation would provide ample consumer protection. Stringent manufacturing guidelines, clear dosage instructions and advice on contraindications, as required by the THMPD, can be put in place and verified to an exceptionally high standard (and base line cost) without paying an additional £120,000 token fee per product, for the privilege and a little logo on your label. We already do so!

  • Andrew Cox said on April 2, 2012 at 8:51 am

    The THMP regulation needs to be subjected to a thorough, independent judicial review before Member States begin implementing it in their various ways. The complexity of the subject has not been adequately addressed by the EU. Four things, amongst others, that the review needs to look at are: 1) The fact that whether as a result of powerful lobbying or as a result of rigid thinking and blind spots typical of bureaucracy, the regulation favours big corporations and adds to the financial burden of small, specialist businesses, almost to the point of making it impossible for many of the latter to continue. Consequently, far from facilitating free trade within the EU and far from protecting the public – both old propaganda chestnuts being repeated ad nauseum – the regulations serve to put power and production into the hands of the few who can afford product licenses and take away freedom of choice from the many, who may purchase their remedies from smaller, specialist companies who cannot afford the license their products. This bias is clear in other EU Directives and needs to be addressed at root. 2) Another fundamental problem is that plants consumed to enhance health (which includes most fresh plant foods) are much more chemically complex than medicinal drugs and simply cannot be squeezed into current scientific testing parameters that drugs are subjected to. This is a fundamental fact that has been ignored in the THMP regs. The cart has been put before the horse! 3) Bigger corporations are more likely to produce standardised extracts of plants. These are clearly different products altogether to whole plant extracts that have not been interfered with, yet they have not stood the test of time unlike whole plant extracts used safely in traditional herbal medicine for centuries. The THMP makes no provision for this distinction yet logically standardised extracts should be subject to more stringent testing if public safety is a true concern. 4) In the UK especially, professional herbalists subject to statutory regulation should be permitted to sell herbal remedies made by themselves to the public (not just as part of a consultation with a client) without having to acquire medicine licenses required of mass-producing corporations. Otherwise it makes a mockery of the statutory regulation of herbalists, saying you’re safe enough to diagnose and treat complex conditions but not to make up and offer to the public a remedy for common, minor ailments.

    Comment Tags: THMP Regulation

  • Stephen Tonkin said on April 2, 2012 at 8:38 am

    All products sold as medicines or remedies should be treated equally: the legislation will then be simplified by not having special cases. The onus must be on the manufacturer to demonstrate, via properly conducted double-blinded randomised control trials that they are both safe and effective. Labeling must include all, and only, those constituents that are verifiable by chemical analysis. Purveyors of herbal products must not be allowed to use special pleading to be exempt. If they really believe that their products are safe and effective, they should not object to their being treated in the same way as proper medicine.

    Comment Tags: herbal Chinese RCT

    • charles Buck said on April 3, 2012 at 8:29 am

      drugs and herbal medicines are NOT the same. New drugs are usually novel chemicals – often substances that have never existed on the planet before and that have never progressed either through the human body or through the ecosystem. Being novel chemicals means that we barely have a clue about them. Herbal medicines have been tested on people, often for thousands of years, and they have been a part of the ecosystem – they are much less likely to have unforseen adverse effects on man and planet than novel chemical drugs.

    • Francesco Savastano said on April 3, 2012 at 3:32 pm

      This is like saying that birds and planes must be treated equally because after all they both can fly..
      that’s insane. Do you realize that what God has given us as food has been eaten and used by men for thousands years?
      Pharmaceutical chemicals are not commonly found in nature, over 95% of them are just made-up molecules, they have been synthesized in a lab and none really knows what can be their effect (even accumulated with other chemicals and with time) on the human body. I am myself a victim of one of such big-pharma chemicals, which is still available on the shelves.
      To be healed again I have been using natural herbs and vitamin supplements with great benefits since then.

  • Andrew Flower said on April 1, 2012 at 6:10 pm

    These regulations needs to be simplified and less emphasis placed on demonstrating (rather spurious) component stability. Complex herbal formulations such as Chinese medicine should be permitted. At present the herbal legislation is seriously undermining people right to choose.

  • haskel adamson said on April 1, 2012 at 10:30 am

    this legislation has been designed to benefit the large pharmaceutical companies who have bought into the herbal industry in anticipation of this legislation. The eu have greated a monopoly of herbal medicine products as only the larger companies can now afford the new licenses. At the same time the new legislation has reduced massively the choice of herbal medicines available to the public as now only the most commercially popular remedies are liable to be licenced. There were many smaller producers of herbal medicine working to high standards who have already or will very shortly go out of business due to this legislation. The use of the word in the title of the legislation ‘traditionall, is like an ironic joke, when this legislation has ripped the heart out of traditional medicine , and allowed it to be superceded by corporate powers.
    An answer would be to have a minimum standard for quality of manufacture and a permissable list of traditional herbal medicines that can be made, based on traditional useage. At present the financial burden to apply for a licence benefits only the regulatory authorities coffers , and the exclusivity of those big companies, who can afford such costs

  • Dr Shah, Eladevi said on March 31, 2012 at 10:12 am

    Definitely they should not be left as they are. If you scrap them altogether we are ready to show you how they could be reformed and better implemented. We under the name of Institute for Complementary Medicine have been working on the process of voluntary codes for last 20 years. Many workers either retired or died. Still this organisation is active in the name of Institute for Complementary and Natural Medicine same as change of MCA to MHRA. Make regulations tougher for practitioners and governing of voluntary codes. There should be three main divisions only. Physical therapy counselling and herbal medicine, First of all identify where are the gaps and who are coming forcefully through back doors and complete control over advertising. Many Web sites may be developed outside UK and products may be regulated by Bulgaria and UK remain unable to control. There should be international cooperation in this concern.

  • Dr Shah, Eladevi said on March 31, 2012 at 10:08 am

    Definitely they should not be left as they are. If you scrap them altogether we are ready to show you how they could be reformed and better implemented. We under the name of Institute for Complementary Medicine have been working on the process of voluntary codes for last 20 years. Many workers either retired or died. Still this organisation is active in the name of Institute for Complementary and Natural Medicine same as change of MCA to MHRA. Make regulations tougher for practitioners and governing of voluntary codes. There should be three main divisions only. Physical therapy counselling and herbal medicine, First of all identify where are the gaps and who are coming forcefully through back doors and complete control over advertising. Many Web sites may be developed outside UK and products may be regulated by Buljeria and UK remain unable to control. There should be international cooperation in this concern.

  • Terry Gallagher said on March 31, 2012 at 9:54 am

    The legislation is a great step forward for herbs as it guarantees quality and safety.
    Weekly pharmacovigilance for THR holders (under the THMPD) should be abolished because it is burdensome and costly. We have sold 50 million herbal licenced tablets a year for many years without any significant adverse reactions.
    The THMPD should allow for ease of adding extract suppliers to the THR registration as supply from one source means you are seriously commercially disadvantaged. At present, certain suppliers which THR holders are restricted to, have increased the price when there is no shortage.
    Make the addition of Braille to the packaging optional (as this is costly to set up and gives very little useful information – only the product name).

  • Loraine Argyle said on March 26, 2012 at 4:42 pm

    Consistency across European Union and ‘common sense’ approach to some products dependant on what they are to be used for and in what quantity. i.e. you can buy chamomile tea which contains a high level of chamomile, and is very invasive, but can’t put it in a medicine/medical device at a much lower rate in the UK. However, you can use it in a medical device if the notified body isn’t in the UK, as the medical directive states that there should be free movement between member states. The latest guidelines penalise not only the manufacturer but also the Notified Bodies, putting two parties at a disadvantage in the market place.
    Most herbal ingredients have been used for a long time in both traditional and medical products and it is unusual not to be able to find a clinical trial that has been done on the ingredient. As long as there is supporting evidence covering safety, then it would remove the need to ‘licence’ these types of products.

  • Mike Hawkins said on March 26, 2012 at 12:49 pm

    The problem with both the THMR as well as the proposals on therapist
    regulation, is the regulations are so badly drafted. They fail to
    differentiate between the various disciplines such as western herbal
    medicine, Chinese, Indian, etc. Traditional medicines which contain
    animal and mineral constituents are not just “herbal”. Therefore I
    question if those should fall under the THMR regulations at all?

    The biggest problem is the EU definition of a “medicinal substance”.
    That definition means almost any common substance such as salt and
    glucose could be classified as “medicinal”. That puts far too much
    potential power in the hands of the MHRA and the courts.

    These regulations should not be instituted in the UK until they are more
    intelligent and fit for what they purport to be about, i.e protecting
    the public. In their current form they do nothing but create a new raft
    of costly bureaucracy.

    The Government have the ability to withdraw us from such legislation if
    it is damaging to the UKs economic interests. It has been done over
    other issues such as bank regulation, prisoners rights, etc. Why not
    over this?

    • Stephen Tonkin said on April 2, 2012 at 8:43 am

      “They fail to differentiate between the various disciplines such as western herbal medicine, Chinese, Indian, etc. ”

      This is a red herring. All products sold as medicines or remedies, regardless of “discipline”, must be subjected to the same regulations and be required to demonstrate, via properly conducted double-blinded randomised control trials that they are safe and effective. If the purveyors of herbal medicines really believed that they are safe and effective, they would not object to their being treated in hte same way as proper medicines.

      Comment Tags: herbal RCT

    • Belfast Herbalist said on April 4, 2012 at 8:08 am

      There is a very clear need to differentiate a pharmaceutical substance – such as a synthetic or isolated active ingredient – from a naturally occurring plant which has an array of active ingredients but can contain constituents which mediate side effects often seen in isolates but not in whole herb preparations. Further whole herb preparations can demonstrate more than one positive action.

      Those who perpetuate the evidence-based, gold plated RCT need to demonstrate an understanding of this very obvious difference if they are to continue to promote the RCT as an accurate assessment.

      Unfortunately the RCT is generally biased to the pharmaceutical model and fails to appreciate traditional whole herb applications and the fact that centuries of established use have already long determined efficacy and safety.

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