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

  • Robert Verkerk PhD said on April 12, 2012 at 3:07 pm

    This is an erratum for the comments we have just submitted, currently in moderation. The first paragraph included an incorrect number of respondents, and should be replaced with the following:

    The following comments are made on behalf of the Alliance for Natural Health Europe (www.anh-europe.org) and are supported by a questionnaire [see summary at: http://www.anh-europe.org/sites/default/files/120412-ANH-Red-Tape-Questionnaire_summary.pdf we prepared associated with the medicines/traditional herbal medicines themes, to which 51 responses were received (34 practitioners, 13 consumers and 4 manufacturers).

    Apologies for the inconvenience caused.

  • Robert Verkerk PhD said on April 12, 2012 at 2:41 pm

    The following comments are made on behalf of the Alliance for Natural Health Europe (www.anh-europe.org) and are supported by a questionnaire [see summary at: http://www.anh-europe.org/sites/default/files/120412-ANH-Red-Tape-Questionnaire_summary.pdf we prepared associated with the medicines/traditional herbal medicines themes, to which 41 responses were received (28 practitioners, 11 consumers and 2 manufacturers).

    In terms of products that may be regarded as traditional herbal products or medicines, we uphold that:
    1. The requirement for registered products to be able to demonstrate 15 years EU use is arbitrary and inappropriate. While it is reasonable to require a 30-year period of safe use in place of safety studies, the requirement to prove 15 years usage in the EU has no scientific rationale and could be regarded as a protectionist measure.
    2. Significant amounts of non-herbal ingredients should be allowed in products on the condition that the products is both safe and ethically-sourced. The restriction of active ingredients to herbal ones unfairly excludes a large number of traditional medicines from the registration scheme. Minerals, in particular, should be allowed where these are used in traditional medicines.
    3. The high cost of data compilation, stability tests and ongoing compliance is a barrier to smaller companies. Simplified data requirements would greatly increase the possibility of herbal products being registered and would avoid the proportionately greater burden on smaller operators that characterise UK herbal suppliers and manufacturers.
    4. The THR scheme’s restriction to minor ailments unfairly limits its applicability.We are not aware of a specific rationale to support the view either a) that herbal products intended to support minor ailments are intrinsically safer than those intended for use in those with major ailments, or b) that persons suffering major ailments who are using herbal products will avoid medical support and will so endanger their health
    5. Food supplements containing the same botanicals sources as those present in products with traditional herbal registrations (THRs) should be allowed to remain on the market if they have a history of safe food or food supplement usage.
    6. Traditional medicines have typically had traditional indications, some of which are not relevant to Western medicine (e.g. because they refer to energetic states or body types, doshas, etc.). The inability to use traditional indications (e.g. for Asian medicines) for products registered as traditional medicines is a problem and could mean that products were not used for the appropriate purpose.
    7. The proposed statutory regulation of herbalists is viewed by many practitioners as being unlikely to adequately safeguard the practice of herbal medicine. Many practitioners are concerned that the rights that have enabled them in the UK to prescribe unregistered herbal medicines under the terms of the Section 12(1) of the Medicines Act 1968 will not be fully carried through to statutory regulation, and/or that significant numbers of practitioners currently practicing herbal medicine may not be able to gain access to the statutory register of herbalists.
    8. Many herbalists are of the view that the Section 12(1) Medicines Act 1968 exemption for herbalists has not exposed patients to unnecessary risk, and therefore does not warrant being repealed.
    Additional comments (9 in total) supplied by respondents to our questionnaire [see http://www.anh-europe.org/sites/default/files/120412-ANH-Red-Tape-Questionnaire_summary.pdf were as follows:
    1. Regulators should look at the figures for deaths and injuries caused by prescription medication – difficult to find in UK as disguised in with other statistics. Compare even a rough estimate to the number of deaths/injuries from herbs and food supplements
    2. We have removed the relevant products from our range as the stock has diminished, however, we have noted that others have not. We feel this creates confusion for consumers and unfair competition, particularly when other companies have launched entirely new, unlicensed, retracted herbal formulas.
    3. If people cant get what they need in the UK (customers) they will source it from elsewhere. This may encourage the black market sale of sub-standard contaminated herbs from elsewhere. What scientific evidence have the MHRA et al got to prove that unlicensed medicines are dangerous when taken as directed on the packet? Shouldn’t they publish proof of their actions too?
    4. There is an unfair bias towards pharmaceuticals. Pharmaceutical companies have large budgets to test all products, at the detriment to patient choice and increased costs to the health care system. There are more deaths and side effects per annum from prescribed drugs than from things that grow naturally. Natural products cannot be controlled in the same way as pharmaceuticals, they by their nature are variable. Chemicals are controllable by manufacturers and therefore should be regulated.
    5. Something that grows wild cannot and should not be controlled. I personally feel that legislation aimed at Traditional Herbal medicines is flawed and is an unnecessary waste of time, money and effort. It also deprives people of choice, not only a choice of medication, but a choice of choosing natural versus chemical.
    6. I have successfully used European and Maharishi Ayurveda products for 35 years. Such use has saved me pain and disability and the NHS many tens of thousands of pounds. There must be freedom to prescribe, use and buy products proven in traditional use.
    7. Herbal practitioners have been safely and conscientiously treating their patients for many years. I know of no herbalist that would even consider using a medicine if they were not sure of its safety, effectiveness or possible interactions with other medicines etc.
    8. Consumers should be allowed to make their own informed choices on what health products or herbs they take. Individual responsibility for ones own health should be encouraged and celebrated. Pharmaceutical drugs are by no means safer or even more effective than herbal remedies. Who gains really from these types of legislative decisions, the public or Big Pharma???????”
    9. Western medicine should get its facts clear about alternative therapies – that they are ‘alternatives’ to the medical format not something that is trying to replace visiting a doctor to help with a broken arm etc. Vitamins, herbs, Ayurveda and traditional Chinese medicine provide an alternative therapy to people where western drugs or treatment pose too many side effects, are too costly, not specific enough for their treatment, or as I mentioned HAVE TOO MANY SIDE EFFECTS. Its about choice. About finding what works for YOU as an individual not as a statistic. Its about using herbs that have been successfully helping people for thousands of years and been ‘tested’ on countless people through time. Western medical ‘trials’ have proven again and again how unsuccessful their model can be (thanks western medicine for your trials with thalidomide), and most drugs are on the market without even having been tested at all. How can western medicine then say that alternative models such as the use of herbs, Ayurveda or traditional Chinese medicine are “untested” when they have been around for much longer that the western model and in some cases have even contributed to treatment methods/drugs now being offered within the western medical system? It is sad that in the end we have to entertain a debate that is all about big companies and the financial threat they feel from ‘alternatives’ to their model. And it is seriously worrying that legislation could take away peoples freedom to make their own informed choices where health is concerned. I know certain western medically minded readers will say “but reaching for vitamin c or a garlic capsule or a cup of raspberry leaf tea isn’t making an informed choice!”, and I guess they’re right, if reaching for Zoloft, Benzodiazepines, Risperdal, Visine or countless other “safe” drugs with serious side effects is a better way to go. Taking away people’s freedom is a worrying and dangerous game to play.

    Comment Tags: ANH, Asian, Ayurveda, practitioner, TCM, THR

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