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.
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?
SCRAP IT ALL , a creeping eventual total control of our foodstuff.Comment Tags: Scrap it.
To remove the need for clinical trials to be carried out on tried and time tested supplements and that, items such as colloidal silver should not be banned because it has not been pharmecutically trialed. When the government is seeking to save money on the burden on the NHS of prescription medicines, herbal supplements and medication should be allowed to continue but with a statment saying that they are at the users risk, rather like drug companies put on their leaflets about the side effects etc. sadly they do not put what damage their medicines cause in the process of correcting an imbalance.
I want to have choice as to how I treat my ailments with accurate information of the pro’s and cons this can also be applied to herbal medicine. Cautions should be made as to overdosing on these but that is all.Comment Tags: Making educated choices
I think the government ought to invrstigate the side effects from main stream pharmaceutical drugs and the damage they do, the money wasted by inefficient dangerous prescribing practices where elderly and sick people have medication prescribed on repeat prescriptions that they no longer need, and the amount of pharmaceutical medication being flushed into our water systems. Herbs are natural and have been benefiting our health for thousands of years. It is the prescribed drugs and how they are prescribed and disposed of that should be the focus of legislation/Comment Tags: herbs and new legislation, supplements
Herbs have been used for thousands of years as medicine safely, without these ludicrous regulations. Scrap the regs. These regs are the thin end of the wedge being used to drive herbs off the shelf for the ordinary person so that they are forced to use pharmaceutical drugs instead. These drugs do far more harm to people than herbs ever have, despite all the so called trials that they are put through.
I think the legislation should be scrapped, and that government attention should be focused on the harm caused by pharmaceutical drugs instead.
People understand that some herbs can be harmful, but in as much as herbal remedies have been in use for thousands of years, I believe that any danger has been minimised by experience and usage .
On the other hand, how many people die or develop disease from the use of toxic medications produced by pharmacuetical companies whose raison d’etre is to make profits to keep their shareholders happy.
Let people take responsibility for their own health with, of course, support from their doctors.Comment Tags: let care and compassion be the rule – not profit
IF SOMETHING AIN,T BROKEN DO NOT FIX IT. Old saying, and has never been superseaded by anything else.
I think it should be scrapped. Remedies that are made from pure ingredients are now becoming unavailable and replaced by ones that have unnecessary, questionable and potentially harmful additives that have EU certification. I would prefer to have the choice of taking remedies with pure ingredients, and am concerned that these new remedies that I am being forced to take against my will will not be as effective as the previous purer ones were.
Scientific Fact. How many cases are documented in this country where a herb has been proven to be the cause of serious illness or death. I would like to know what I am being protected from. What facts have caused the necessity for such draconian,costly and unpopular measures in this country? I believe I may no longer state to customers that water would correct dehydration, therefore isnt the public already protected from erroneous advice? Why cant the public be trusted to make their own choices? If they feel that something is unsafe, they won’t buy it, it won’t sell and the the supply and demand economics will collapse.Comment Tags: stop being dictated to by the large pharmicutical companies
I think the legislation should be scrapped, and that government attention should be focused on the harm caused by pharmaceutical drugs instead.
SCRAPPING IT would be the biggest improvement but failing that, instead of restricting sales of certain herbs etc, where there are interactions with drugs (St Johns Wort for instance) then appropriate warnings should be on the labels. Let’s face it, had asprin been a recent discovery it probably would never have made it to the market yet herbs, which have been used for centuries, are under threat, it’s stupid to say the least.Comment Tags: are under threat, herbs, it’s stupid to say the least., which have been used for centuries
Scrap the act as it is unnecessary and a bar to free trade.
I believe the law is misguided and should be thought out in a balanced and informed manner. It is attempting to take away our right to take responsibility for our own health, and it will dramatically affect jobs.
I am very disappointed in the authoritarian stance of the EU lawmakers. It is attempting to control & take away choice from people to take comparatively harmless & health giving natural herbs that have been traditionally used throughout the world.
The unreasonable levies for THMPD registration are anti competitive giving large companies carte blanche whilst smaller companies will have to stop trading as they could not afford the swinging charges.
Where is the logic that allows a potential poison, for example such as paracetamol to be readily available, and yet beneficial herbs are to be controlled in such a heavy handed way.
Highly undesirable tobacco, proven carcinogens in cold meats & gas guzzling polluting automobiles are allowed though saw palmetto & gingko biloba is not, George Orwell could not have written a more bizarre storyComment Tags: Our right to choice and freedom to take responsibility for our own health
Please just leave the system as it is. It served us well for many years. This is just something to satisfy pharmaceuticals and beauracrats.
We have enaugh of goverments telling us what to do
The legislation is totally unnecessary and contrived in order that the large pharaceutical companies can make more money. It is not to protect our health. NATURAL MEDICINE IS BETTER AND CHEAPER.Comment Tags: Let us keep our freedom of choice.
The legslation should be scrapped. People should be allowed to consume whatever herbs, vitamins and supplements they like. The State Busy Bodies & Quango Apparatchiks should find other things to do.
I think we should scrap the regulations altogether and allow us, as grown up human beings with brains, to make up our own minds as to what we believe in, and ingest what we believe, are highly effective complementary solutions to our health regimes.Comment Tags: STOP THE RED TAPE AND MARCH OF THE NANNY STATES
Get RID of the RED TAPE the EU give us. We do not need it. WIthout the herbal supplements in the format they are in I would NOT be here. As they have given me back my health. I know I speak for many. We apparently have our human rights along with iledged our rights – what about our right to choose what we buy and in what format regarding herbal mediciene.Comment Tags: STOP READ ACT NOW AND LISTEN TO US PLEASE
The legislation should be dropped entirely. We do not need someone to tell us whether we can use a certain herb or vitamin supplement. We are responsible for our own life in front of our Creator. An unelected government in the EU wants to dictate what we need to eat and buy. Everything what God gave us to eat is good to eat, now they come and they tell us that God’s given food must be subjected to big pharmaceutical companies diktats and billionaire procedures, for increasing their revenues by limiting the health choice available for every individual. Hundreds thousands people die because of pharmaceutical drugs side effect, none ever died by using traditionally consumed herbs and supplements.
I would propose a different legislation, every food available in nature should be considered SAFE for the general public until proven the contrary by a multibillion dollars study. Not the other way around. On the opposite, every synthetic food (partially or totally synthesized in a chemical plant) must be considered UNSAFE until proven safe by a multibillion dollars studyComment Tags: Freedom of choice, health right, supplements
I would just like to say that i do not wish to be dictated to by the government as to the products i choose to take for whatever reason! I f they can dish out toxic chemicals in the form of drugs via the NHS, i wish to be free to choose safer alternatives.
It’s legal to fill our foods with synthetic chemicals and additives but not eat pure natural foods that have health benefits because one person might react bad and die? Ban peanuts then…
I’ve given up voting as what’s the point when we’re ruled by world quangos.